Coronavirus, COVID-19 & Clinical Research: an overview

Last updated: 1 November 2020, 6:17 PM (CET)

This page is no longer being actively updated and information presented on this page may be outdated. Other information will be transferred to the “Biomedical Research” section of the weblog. Please check the websites of the organizations for the most up-to-date information.

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Content

Public consultations Global Europe/European Union Countries Africa America (North & South) Asia Australia Europe Middle East Organizations, Professional Associations, Research Networks Clinical trials Biobanking, Biospecimens Patient Registries, Artificial Intelligence, Data management, Datasets Resources Grants Other news Webinars

Quick links ACRO Clinical trial registries European Medicines Agency Investigational Medicinal Products Netherlands United Kingdom United States World Health Organization   Suggestions, missing links or broken links? Please use the contact form or covid@bontrop.com to contact me.

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Global

International Coalition of Medicines Regulatory Authorities (ICMRA)

During the ongoing COVID-19 pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) is acting as a forum to support strategic coordination and international cooperation among global medicine regulatory authorities.

• COVID-19

International Pharmaceutical Federation (FIP)

• FIP Covid-19 Information Hub

Nuffield Council on Bioethics

• COVID-19 ethics resources
• Health and society: COVID-19
• Liberty, solidarity and the biopolitics of COVID-19 (1 April 2020).
• Nuffield Council on Bioethics. Research in Global Health Emergencies. January, 2020.
• Research ethics: Research in global health emergencies

Patient Focused Medicines Development (PFMD)

• Coronavirus Resource Hub.

UNESCO/International Bioethics Committee

• Statement on COVID-19: ethical considerations from a global perspective

Unicef

• Discussion Paper: Ethical Considerations for Evidence Generation Involving Children on the COVID-19 Pandemic (April 2020). Unicef.

World Health Organization

• Global research on coronavirus disease (COVID-19)
• R&D Blueprint and COVID-19. Coronavirus disease (COVID-2019).
• WHO: Epidemic Intelligence from Open Sources (EIOS)
• Country & Technical Guidance – Coronavirus disease (COVID-19)
• Coronavirus disease (COVID-19): Vaccines (Q&A).
• Coronavirus disease (COVID-19): Vaccine research and development (Q&A)
• Global leaders unite to ensure everyone everywhere can access new vaccines, tests and treatments for COVID-19 (24 April 2020).
• Ethics and COVID-19: resource allocation and priority-setting (20 April 2020).
• Guidance
  • Ethics
    • Ethical Standards for Research During Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. 2020.
    • Ethical Considerations for Use of Unregistered Interventions for Ebola Viral Disease: Report of an Advisory Panel to WHO. 2014.
  • Laboratory tests, Biospecimens
    • Laboratory testing for coronavirus disease (‎‎COVID-19)‎‎ in suspected human cases: interim guidance (19 March 2020).
    • Laboratory biosafety guidance related to coronavirus disease (‎COVID-19)‎: interim guidance (19 March 2020).
    • Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus: interim guidance (2 March 2020)
    • Laboratory testing of human suspected cases of novel coronavirus (‎‎‎‎‎‎‎‎nCoV)‎‎‎‎‎‎‎‎ infection: interim guidance (10 January 2020)
  • Research
    • Core Protocol for vaccines against COVID-19 (17 April 2020).
    • Overview of the types/classes of candidate therapeutics (21 March 2020).
    • COVID-19 Therapeutic Trial Synopsis (18 February 2020).
    • Outline of trial designs for experimental therapeutics (27 January 2020).
    • Outline of designs for experimental vaccines and therapeutics (20 January 2020).
  • Clinical management,Vaccination
    • Guiding principles for immunization activities during the COVID-19 pandemic (24 April 2020).
    • Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected, Interim guidance (13 March 2020).
    • Vaccination in Acute Humanitarian Emergencies. A Framework for Decision Making. May 2017.

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Europe/European Union

Association of European-level Research Infrastructure Facilities (ERF-AISBL)

• Research Infrastructures and COVID-19 Research

CEN CENELEC

• CEN and CENELEC make European standards available to help prevent the COVID-19 contagion (20 March 2020).

Council of Europe

• The Chair of the Committee of Convention 108 and the Data Protection Commissioner of the Council of Europe recall the principles of data protection in these times of fight against the COVID-19 pandemic (30 March 2020).
• Saving lives, respecting data protection (30 March 2020).

European Centre for Disease Prevention and Control

• COVID-19 pandemic

European Clinical Research Infrastructrure Network (ECRIN)

• European Research Infrastructures against COVID-19
• COVID-19 Taskforce.
• COVID-19 Trials registries
• Regulatory – ethical considerations for ongoing trials during Pandemic
• Fast track procedure for COVID 19 Clinical trials.
• Clinical Research Metadata Repository
• COVID-19 Literature reviews
• Other COVID-19 resources

European Commission

• Coronavirus research
• Monitor research landscape Covid 19
• Coronavirus response: Public health
• European Commission research actions on Coronavirus (Coronavirus factsheet) (March 2020).
• Joint Research Centre
  • Solidarity with Europe – JRC science to tackle the coronavirus crisis (31 March 2020). EU Science Hub.

European Confederation of Pharmaceutical Entrepreneurs (AISBL)

• COVID-19 Corona Virus updates

European Council

• Conclusions by the President of the European Council following the video conference on COVID-19 (10 March 2020).

European CRO Federation (EUCROF)

• COVID-19 Pandemic: Information & Guidance
• CORONAVIRUS and Clinical Trials – Advice requested from EMA (13 March 2020)
• Legislations & Regulations

European Data Protection Board

• Guidance
  • Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak (21 April 2020).
• Statements
  • Statement on the processing of personal data in the context of the COVID-19 outbreak (20 March 2020).
  • Statement of the EDPB Chair on the processing of personal data in the context of the COVID-19 outbreak (16 March 2020).
• Plenary sessions
  • Twenty-fourth Plenary session: EDPB doubles down on COVID-19 guidance in newly adopted letters (24 April 2020).
  • Twentieth plenary session of the European Data Protection Board – scope of upcoming guidance on data processing in the fight against COVID-19 (7 April 2020).
    • Request for mandate regarding the processing of health data for research purposes in the context of the COVID-19 outbreak – CEH ESG (7 April 2020).
    • European Data Protection Board to issue guidance on data processing in the fight against COVID-19 (3 April 2020).

European Medicines Agency

• Guidance and conditions
  • Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic.
  • Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials.
  • Guidance on remote GCP inspections during the COVID-19 pandemic (18 May 2020).
• COVID-19: What’s new
• Coronavirus disease (COVID-19).

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

• ENCePP Steering group: Mandate for ENCePP support to COVID-19 activities (25 mei 2020). EMA.
• EU PAS Register

EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) encouraged all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register. They should also upload and make their study protocols public, with a description of the data collected or planned to be collected. This is to facilitate collaborations and speed up the design of observational studies by others. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of all COVID-19-related studies via the ‘Title of Study’ search filter.
– Bron: EMA

Heads of Medicines Agencies

• Link to National guidance on CT management during the COVID-19 pandemia

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Countries

Europe

Netherlands

• CBG
  • Column ‘Over medicijnen’: Waarom doen we zo moeilijk? (6 May 2020).
  • Speciaal wetenschappelijk advies voor onderzoek naar medicijnen tegen COVID-19 (23 April 2020).
  • Oproep EMA: werk samen in onderzoek naar medicijnen tegen corona (20 March 2020).
  • Updates: Medicijnen tegen coronavirus en beschikbaarheid van andere medicijnen
• Centrale Commissie Dierproeven (CCD)
  • Verlengen onderzoeksperiode dierproef is mogelijk vanwege Corona-maatregelen (10 April 2020).
  • Coronamaatregelingen en projectbeoordeling (23 March 2020).
• Centrale Commissie Mensgebonden Onderzoek (CCMO)
  • Informatie CCMO naar aanleiding van uitbraak coronavirus.
• IGJ:
  • Guidance and conditions
    • Coronavirus (COVID-19): impact op het verrichten en uitvoeren van klinisch onderzoek dat onder de Wet medisch wetenschappelijk onderzoek met mensen (WMO) valt.
    • Voorwaarden (her)start klinisch onderzoek, niet zijnde klinisch onderzoek op CRU’s.
  • News
    • Klinisch onderzoek met proefpersonen kan gefaseerd hervat worden (25 June 2020).
    • Klinisch onderzoek met proefpersonen in clinical research units kan gefaseerd hervat worden (22 May 2020).
    • Coronavirus: impact op klinisch onderzoek met proefpersonen (14 April 2020).
    • IGJ stopt alle reguliere inspecties (31 March 2020). Skipr.
    • Coronavirus: gevolgen voor GMP- en GDP-inspecties en -certificaten (21 March 2020).
    • Coronavirus: impact op medisch-wetenschappelijk onderzoek met mensen (20 March 2020).
    • Meldpunt bij IGJ ook in het weekend open (20 March 2020)
• KNAW
  • Uitloop van onderzoekstrajecten: onderzoeksinstellingen werken aan oplossingen (8 April 2020). VSNU, NFU, NWO, ZonMw, PNN en Postdoc.nl.
    • Hulp bij uitloop onderzoekstrajecten (10 April 2020).
• Loket Gentherapie
  • Onderzoek naar behandeling en vaccin COVID-19 versneld middels spoedregeling (2 April 2020).
  • From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority (16 March 2020).
  • Vanaf 13 maart 2020 indiening onderzoeksdossiers gentherapie en geneesmiddelen met GGO rechtstreeks bij betrokken instantie (13 March 2020).
• Ministerie IenW
  • Regeling van de Minister van Infrastructuur en Waterstaat van 28 maart 2020, nr. IENW/BSK-2020/57427, houdende spoedmaatregelen met betrekking tot gentherapie ter bestrijding van COVID-19 (Tijdelijke regeling afwijkende behandeling vergunningaanvragen gentherapie in verband met bestrijding COVID-19). Staatscourant (30 March 2020).

• RIVM
  • Databronnen COVID-19
  • Coronavirus kaart van Nederland per gemeente
  • Informatie over coronavirus (COVID-19) voor zorgprofessionals
• GDPR (Algemene verordening gegevensbescherming)
  • COREON publiceert statement over nader gebruik van patiëntgegevens bij spoedsituaties (7 April 2020). Nieuwsbrief voor Goede Onderzoekspraktijken, supplement Nieuwsflits.
  • Statement delen van patiëntgegevens bij observationeel wetenschappelijk onderzoek in spoedsituaties (6 april 2020). COREON.

Belgium

• AFMPS/FAGG
  • Guidance on the Management of Clinical Investigations during the COVID-19 (Coronavirus) pandemic.
    • Coronavirus: nationale richtlijn voor het beheer van klinische onderzoek voor medische hulpmiddelen tijdens de coronaviruspandemie (3 May 2020).
  • Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 2 (29 April 2020).
    • Coronavirus: nieuwe versie Belgische richtsnoer voor het beheer van klinische proeven tijdens de coronaviruspandemie (30 April 2020).
  • Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, version 1 (25 March 2020).
    • Coronavirus: Belgische richtsnoer voor het beheer van klinische proeven tijdens de coronaviruspandemie (25 March 2020).
  • Coronavirus: vergunning voor eerste klinische proef met COVID-19-vaccin in België (19 June 2020).
  • Coronavirus – hydroxychloroquine: off-label gebruik sterk ontmoedigd en nieuwe baten/risicoanalyses voor klinische proeven (27 May 2020).
  • Richtlijn voor rechtstreekse aflevering van geneesmiddel aan patiënt in klinisch proef (16 March 2020)
  • COVID-19: elektronische indiening van dossiers (14 March 2020)
• Verkorte termijn voor klinische studies voor vaccins en nieuwe behandelingen tegen COVID-19 (4 April 2020). Pharma.be.
• Federale Regering en Belgische biofarma-industrie versnellen de inspanningen in de strijd tegen COVID-19 (4 April 2020). Pharma.be.
• Expertise bundelen in de strijd tegen COVID-19 (4 April 2020). Pharma.be.
• Via BeCRO: COVID-19 impact on clinical trials, please find hereby communication from the agency (13 March 2020)
• (Research) Ethics Committee
  • Ethics Committee Research UZ/KU Leuven: COVID-19 Advice EC Research
• GDPR
  • Belgium: Public Health and Data Privacy are Not Incompatible (16 March 2020). LexBlog.
  • Belgian Supervisory Authority Issues Guidance on Data Protection and Coronavirus (16 March 2020). LexBlog.

Austria

• BASG
  • Clinical studies and COVID-19
  • Frequently Asked Questions
  • Häufige Fragen

Bulgaria

• Recommendations to the Sponsors for managing of Clinical Trials during the COVID-19 pandemic and the declared State of emergency in the Republic of Bulgaria

Czech Republic

• Opinion of SÚKL’s Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation

Croatia

• Smjernice Ministarstva zdravstva vezano uz provođenje kliničkih ispitivanjaza vrijeme pandemije bolesti COVID-19 v.1

Denmark

• Lægemiddelstyrelsen
  • Extraordinary measures for clinical trials due to COVID-19
  • COVID-19: Danish Medicines Agency puts inspection and control tasks on hold (26 March 2020).

Estonia

• Ravimiamet: Guidance on clinical trial management in the context of COVID-19 pandemic

Finland

• FIMEA: Clinical trials during the coronavirus epidemic (COVID-19)

France

• ANSM
  • Covid 19 – Ongoing clinical trials
• GDPR
  • CNIL
    • Recherches sur le COVID-19 : la CNIL se mobilise (26 March 2020).
    • Coronavirus (Covid-19) : les rappels de la CNIL sur la collecte de données personnelles.
  • COVID-19: ANSM guidance on Data Protection requirements for on-going trials (20 April 2020). Bird & Bird.
  • Recommendations by the CNIL in the Context of COVID-19 (16 March 2020). LexBlog.
  • France Offers Guide for Processing COVID-19 Related Data Under GDPR (9 March 2020). LexBlog.

Germany

• BFArM
  • Clinical Trials during the COVID-19 Pandemic – Information on the authorisation and conduct of clinical trials of medicinal products during the COVID-19 pandemic
  • Supplementary recommendations to the document European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
  • Klinische Prüfungen während der COVID-19 Pandemie – Hinweise zur Genehmigung und Durchführung klinischer Arzneimittelprüfungen während der COVID-19 Pandemie
  • Ergänzende Empfehlungen zum Europäischen Dokument Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
  • New information in the topic Clinical Trials
•  GDPR
  • BfDI: Datenschutzrechtliche Informationen zur Verarbeitung von personenbezogenen Daten durch Arbeitgeber und Dienstherren im Zusammenhang mit der Corona-Pandemie.
  • New German Legislation Facilitates Scientific Research in the Health Sector (7 April 2020). LexBlog.
  • German Authorities Issue Guidance Related to Coronavirus (17 March 2020). LexBlog.

Greece

• National Organization for Medicines

Hungary

• OGYÉI: Information on the continuity of clinical trials under COVID-19 (coronavirus)
• Tájékoztatás klinikai vizsgálatok folytonosságáról a COVID-19 (koronavírus) alatt (24 March 2020).
• OGYÉI: Koronavírus

Ireland

• HPRA: Guidance on the Management of Clinical Trials during COVID-19 (Coronavirus).

Italy

• AIFA
  • COVID-19 Emergency

Latvia

• ZVA: Potential changes in the conduct of clinical trials in relation to COVID-19
• ZVA: Iespējamās izmaiņas klīnisko pētījumu veikšanā saistībā ar COVID-19

Norway

• Statens legemiddelverk (NoMA): Management of Clinical Trials in relation to covid-19.

Portugal

• Infarmed: COVID-19
• Infarmed: Ensaios clínicos
• Infarmed: COVID-19: Medidas excecionais no âmbito da realização de Ensaios Clínicos durante o período de risco para a saúde pública

Romania

• AMNDMR
  • COVID-19 Clinical Trials Information
  • In atentia Companiilor care desfasoara studii clinice (25 March 2020).
  • In atentia companiilor care desfasoara studii clinice in Romania.

Slovakia

• ŠÚKL: Mimoriadne opatrenia pre klinické skúšania v dôsledku COVID-19 (16 March 2020).
• ŠÚKL: Usmernenie – výdaj skúšaných liekov pacientom v klinickom skúšaní počas mimoriadnej situácie COVID – 19 (13 March 2020).
• ŠÚKL: Extraordinary measures for clinical trials due to COVID-19.

Slovenia

• JAZMP: Koronavirus (COVID-19) – obvestilo glede poslovanja JAZMP (13 March 2020).

Spain

• AEMPS: Medidas excepcionales aplicables a los ensayos clínicos para gestionar los problemas derivados de la emergencia por COVID-19
• AEMPS: Última información de la AEMPS acerca del COVID-19.

Switzerland

• Swissmedic: Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic

Ukraine

• COVID-19: Ukraine makes possible access to new therapies and off-label use (1 April 2020). Borys Danevych, via LinkedIn.

United Kingdom

• National Institute for Health Research
  • A framework for restarting NIHR research activities which have been paused due to COVID-19 (21 May 2020).
  • Urgent Public Health COVID-19 Studies.
• NHS Health Research Authority
  • COVID-19 research (guidance etc.)
  • Approved COVID-19 research
  • Timelines for fast-track review during the COVID-19 pandemi
  • COVID-19: Guidance for sponsors, sites and researchers (v2.2 26 March 2020)
  • Pharmacy and Radiation Assurance for COVID-19 studies
  • Research in the NHS during the COVID-19 pandemic
  • NHS Health Research Authority COVID-19
• MHRA – Guidance
  • Guidance – Managing clinical trials during Coronavirus (COVID-19)
  • Guidance – Clinical trials applications for Coronavirus (COVID-19)
  • Guidance – Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
  • Guidance MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
  • Guidance Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
  • Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak.
  • Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
  • Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)
  • Guidance Good laboratory practice (GLP) for safety tests on chemicals
  • Guidance on Coronavirus (20 March 2020).
  • Collection – MHRA guidance on Coronavirus (COVID-19)
• MHRA – Other
  • Press release COVID-19 treatments could be fast-tracked through new national clinical trial initiative (29 April 2020).
  • MHRA approves COVID-19 vaccine trial in 7 working days (23 April 2020).
  • Status of Phase 1 clinical trials in response to coronavirus (COVID-19) (31 March 2020).
  • MHRA Good Practice (GxP) inspections during the COVID19 outbreak (23 March 2020).
  • New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19) (20 March 2020).
  • Advice for Management of Clinical trials in relation to Coronavirus (12 March 2020)
  • Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak (29 April 2020). European Pharmaceutical Review.
• Public Health England
  • Guidance COVID-19: safe handling and processing for samples in laboratories.
• GDPR
  • ICO: Data protection and coronavirus: what you need to know
  • ICO: Data protection and coronavirus (12 March 2020).

Africa

Kenia

• Guidance to Sponsors and Investigators for Conduct of Clinical Trials During the COVID-19 Pandemic in Kenya.

South Africa

• SAHPRA Policy on Conduct of Clinical Trials of Health Products during the current COVID-19 Pandemic

America

Brazil

• Condução de pesquisas clínicas autorizadas pela Anvisa e estudos de bioequivalência (BE), considerando as medidas de enfrentamento do novo coronavírus

Canada

• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors.

Colombia

• INVIMA: Descargar medidas excepcionales de investigacion clinica
• INVIMA: Preguntas frecuentes para Centros de investigación clínica, Comités de ética y Patrocinadores/CRO frente a planes de contingencia por COVID-19
• INVIMA: Estrategia de evaluación expedita de protocolos de investigación con medicamentos para COVID-19.
• INVIMA: Lineamientos investigación clínica Coronavirus (COVID-19)

Peru

• OGIT: Fecha de publicación en la página web del REPEC: 30 de marzo  2020
• OGIT: Fecha de publicación en la página web del REPEC: 26 de marzo  2020. Medidas excepcionales de seguridad aplicables a los ensayos clínicos en atención al Decreto Supremo que declara Estado de Emergencia Nacional por las graves ircunstancias que afectan la vida de la Nación a consecuencia del brote del COVID-19
• OGIT: Fecha de publicación en la página web del REPEC: 18 de marzo  2020

United States

• CDC:
  • Information for Laboratories
  • Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
  • Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
• FDA
  • COVID MyStudies Application (App)
    • COVID MyStudies Application (App)
    • FDA’s MyStudies Application (App) Technical Background
    • GitHub: FDA MyStudies Mobile Application System
    • Google Play: COVID MyStudies
  • Guidance
    • Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
    • Guidance for Industry on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
    • Guidance for Industry: Development and Licensure of Vaccines to Prevent COVID-19 (June 2020).
    • Guidance for Industry – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
    • Guidance for Industry – Investigational COVID-19 Convalescent Plasma
    • Recommendations for Investigational COVID-19 Convalescent Plasma.
  • Other
    • Coronavirus Treatment Acceleration Program (CTAP)
    • Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections (10 March 2020).
    • Coronavirus Disease 2019 (COVID-19)
• NIH
  • Coronavirus (COVID-19)
  • Ethical Considerations for Zika Virus Human Challenge Trials. Report and Recommendations. 2017.
• Office for Human Research Protections
  • OHRP Guidance on COVID-19

FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. FDA has issued guidance for industry, investigators, and IRBs. The guidance is intended to provide general considerations to assist in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
– FDA, 18 March 2020

• National Academy of Sciences, Engineering, and Medicine
  • Integrating Clinical Research into Epidemic Response: The Ebola Experience. 2017.

Asia

Japan

• PMDA pledge to tackle COVID-19 Pandemic (31 March 2020)
• Pharmaceutical and Medical Device Agency (PMDA) guidance on handling clinical trials during COVID-19
• Q & A on conducting clinical trials of pharmaceuticals under the influence of new coronavirus infection (2 April 2020)

Singapore

• HSA: Guidance on the Conduct of Clinical Trials in Relation to the COVID-19 Situation

Australia

Australia

• TGA/NHMRC/CTPRG: COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors

Middle East

Jordan

• Jordan Food & Drug Administration: Non-binding guideline on managing Clinical Trials during COVID-19.
• Clinical Studies Continuity in Jordan during COVID-19 (29 March 2020). Rana Musa al-ali “Malkawi”, via LinkedIn.

Turkey

• COVID-19 Pandemisi Nedeniyle Klinik Araştırmalarda Alınacak Tedbirler Sıkça Sorulan Sorular.

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Organizations, Professional Associations, Research networks

Association of Clinical Research Organizations (ACRO)

• Considerations to Support Clinical Trial Monitoring Oversight During COVID-19 (13 March 2020).
• ACRO’s Recommendations in order to Support Clinical Trial Monitoring Oversight During COVID-19
• ACRO Feedback on Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020).
• The Global Clinical Research Industry’s Commitment to Collaboration during the COVID-19 Pandemic (17 March 2020).
• COVID-19 Resource Center
• COVID-19 Member Corner

Associatie van Contract Research Organisaties in Nederland (ACRON)

• Onderzoek tijdens COVID-19: is remote SDV een optie? Hoe gaat patiënttoestemming in spoedsituaties? Extra ACRON nieuwsbrief (9 April 2020)
• VIG en ACRON in overleg met IGJ over mogelijkheden remote SDV (8 April 2020).
• ACRON levert input voor update sponsor-richtlijn Europese Commissie.
• Klinisch onderzoek ten tijde van de coronacrisis (25 March 2020).

Association of Clinical Research Professionals (ACRP)

• COVID-19 News & Resource Center
• FDA Issues ‘All-Hands’ Program to Battle Coronavirus, Boost Clinical Trial Efforts (1 April 2020).

Clinical Data Interchange Standards Consortium (CDISC)

• Interim User Guide – COVID-19.

Clinical Trials Transformation Initiative

• Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials (19 June 2020). Clinical Trials Transformation Initiative.
• Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet (18 May 2020).

Coalition for Epidemic Preparedness Innovation (CEPI)

• Calls for proposals.
• CEPI’s response to COVID-19
• CEPI publishes analysis of COVID-19 vaccine development landscape (9 April 2020).

Cochrane

• Cochrane: Coronavirus (COVID-19) – Cochrane resources and news
• An update on Cochrane’s COVID-19 response (18 March 2020).

Combacte

• COMBACTE: Statement: PREPARE Activated to Mode 3 as Novel Coronavirus Cases in Europe are Rapidly Increasing (4 March 2020).

Drug Information Association

• DIA Now In Focus: COVID-19

Dutch Clinical Research Foundation

• DCRF enquête impact COVID-19 resultaten (management samenvatting), versie 1.2, d.d. 11 mei 2020.
  • Resultaten DCRF-enquête knelpunten klinisch onderzoek tijdens coronacrisis (19 mei 2020).
  • Bart Scheerder bij BNR Radio over impact coronacrisis op klinisch onderzoek (25 mei 2020).
    • Luister naar fragment BNR Nieuwsradio: Bart Scheerder over impact coronacrisis op klinisch onderzoek’
  • Veel klinisch onderzoek in problemen door covid-19 (22 mei 2020). Medisch Contact.
  • ‘Klinisch onderzoek viel rigoureus stil bij corona-uitbraak’ (18 mei 2020). Zorgvisie.

European Network of Research Ethics and Research Integrity (ENERI)

• COVID-19 – The importance of research ethics and research integrity standards during the pandemic.

Global Infectious Diseases and Epidemiology Network (GIDEON)

• Global Infectious Diseases and Epidemiology Network (GIDEON)

Health-RI

• Dutch Covid-19 Data Support Programme
• COVID-19 related data initiatives
• Call for COVID-19 data initiatives (26 March 2020).
• Health-RI facilitating COVID-19 research.
  Dutch Covid-19 Research Data Support Programme. (26 March 2020).
• Podium : Providing access to data
• Personal Health Train: Making data interoperable
• XNAT: Sharing Radiology images

International Association of Privacy Professionals (IAPP)

• COVID-19 Guidance and Resources
• DPA guidance on COVID-19.
• Infographic: IAPP Resources for COVID-19.
• How is COVID-19 affecting privacy programs? A call for research action (10 April 2020).

Life Science Research Infrastructures

• LS RIs Respond to COVID-19

Medical associations and organizations

• American Board of Radiology (ABR)
• American College of Physicians (ACP)
• American College of Radiology (ACR)
• American Lung Association
• American Medical Association (AMA)
• American Public Health Association (APHA)
• American Roentgen Ray Society (ARRS)
• American Society of Clinical Oncology (ASCO)
• American Society of Radiologic Technologists (ASRT)
• Canadian Association of Radiologists (CAR)
• European Society of Radiology (ESR)
• Federatie Medisch Specialisten
  • Overzichtspagina COVID-19
  • Richtlijnen, handreikingen, leidraden
• National Academy of Medicine
• Nederlands Huisartsen Genootschap (NHG): Dossier Coronavirus (COVID-19)
• Nederlandse Vereniging voor Medische Oncologie (NVMO): Dossier COVID-19
• Radiological Society of North America (RSNA)
  • Radiology of Coronavirus: Spectrum of imaging findings
  • RSNA Case Collection: Coronavirus Cases
  • Images in Radiology
• The Royal Australian and New Zealand College of Radiologists (RANZCR)
• Society of Critical Care Medicine (SCCM)
  
  • SCCM COVID-19 Journal Articles
  • Webcast series addresses clinical issues and questions related to the pandemic.
  • Critical Care for the Non-ICU Clinicians – Free Training for Non-ICU Clinicians

Pharma.be

• Topic COVID-19
• Covid-19: versnelde procedures voor de behandeling van aanvragen voor klinische studies (20 May 2020).

Regulatory Science Network Netherlands

• Covid-19: Regulatory response to the public health crisis (31 March 2020).

Research Data Alliance

• RDA-COVID19
• RDA COVID-19 Case Statement (30 March 2020).
• Data Together COVID-19 Appeal And Actions (30 March 2020).

Research Quality Association (RQA)

• Discussion Forums: COVID-19

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Clinical trials

BMC Trials

• COVID-19 randomised trial protocols: rapid publication without barriers

Centre for Evidence-Based Medicine (CEBM)

• Covid-19 TrialsTracker
• Oxford COVID-19 Evidence Service
• COVID-19 Registered Trials – and analysis (17 March 2020).

Clinical trial data sharing

• Vivli: A global clinical research data sharing platform
• Vivli: Share your COVID-19-related Trials on the Vivli Portal

Clinical trial registries, Research registries

• ENCePP: EU PAS Register

EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) encouraged all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register. They should also upload and make their study protocols public, with a description of the data collected or planned to be collected. This is to facilitate collaborations and speed up the design of observational studies by others. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of all COVID-19-related studies via the ‘Title of Study’ search filter.
– Bron: EMA

• EU Clinical Trials Register: Clinical trials for COVID-19
• Nederlands Trial Register: Trials for COVID
  The search function of NTR is not so accurate. Search results also shows trials not associated with COVID-19.
• WHO International Clinical Trials Registry Platform (ICTRP): WHO ICTRP Search Portal
  To view the COVID-19 trials worldwide you must enter the search term ‘Covid-19’ in the search field.

Clinical trial trackers, Study registries, Therapeutics trackers, Vaccine Trackers

• Artis Ventures:
  • Fight the Pandemic
  • Diagnostics in development
  • Treatments in development
  • Vaccines in development
• Bill & Melinda Gates Foundation, Cytel: Global Coronavirus COVID-19 Clinical Trial Tracker.
• Clinical Trials Viewer – Search for clinical trials and FDA info
• Cochrane’s COVID-19 Study Register
• HealthMatch COVID-19 Clinical Trials Tracker
• Heidelberg University
  • Mapping COVID-19 Research
  • COVID-19 Map of Hope
• London School of Hygiene & Tropical Medicine
  • COVID-19 vaccine development pipeline
• Milken Institute
  • COVID-19 Treatment and Vaccine Tracker
• National Institute for Health Research (NIHR)
  • Innovation Observatory – COVID-19 Updates – daily updates in the dashboard below of clinical trials in the pipeline for potential Coronavirus (COVID-19) treatments
• NHS Health Research Authority
  • Approved COVID-19 research
• Regulatory Focus
  • COVID-19 Therapeutics Tracker
  • COVID-19 Vaccine Tracker
• STAT
  • STAT’s Covid-19 Drugs and Vaccines Tracker.
• Trial Insights
  • Portfolio Summary: Covid-19 OR Coronavirus
  • Trial Insights Data Sources
• Trial Scope
  • Coronavirus Clinical Trials
• Other
  • A real-time dashboard of clinical trials for COVID-19 (24 April 2020). The Lancet.

Clinical Research Organisations

• COVANCE
  • Coronavirus (COVID-19) Update
• Delta Healthcare Consulting
  • Covid-19 – Clinical Trial Rescue (16 March 2020). (‘visit subject at home‘)
• ICON
  • COVID-19 CEO Letter
  • Coronavirus Observatory
• IQVIA
  • White paper – Rising to the challenge. Five key focus areas for Life Sciences during and after the COVID-19 pandemic (7 April 2020).
  • COVID-19 Trial Matching Tool
    Trial matching tool that includes all research projects seeking participants in the United States.
  • IQVIA launches new COVID-19 trial ‘matching service’ in U.S. (7 April 2020). Fierce Biotech.
• Medidata
  • COVID-19 Regulatory Developments Impacting Technology Use in Clinical Trials (23 March 2020).
  • COVID 19 and Clinical Trials: The Medidata Perspective (23 March 2020).
• PRA Health Sciences
  • Maatregelen vanwege Coronavirus: Onderzoekscentrum in Groningen sluit tijdelijk voor onderzoeken met gezonde deelnemers. (1 April 2020).
• Robarts Clinical Trials: RCTI Covid-19 Sponsor Update (26 March 2020).

Clinical research resources

• ISARIC
  • COVID-19 Clinical Research Resources
  • Novel Coronavirus (nCoV) Acute Respiratory Infection Clinical Characterisation Data Tool.
• The Global Health Network
  • Clinical Characterisation Protocol (CCP)
  • UK-Public Health Rapid Support Team Knowledge Hub
  • Kownledge Hub Coronavirus Outbreak
  • Course: Research in global health emergencies: Ethical issues
  • Resource List: Social Science Research during the COVID-19 Pandemic (6 August 2020).
  • Open Workshops.
• Advarra
  • Coronavirus Guidance – Answers to Your Urgent Questions About the Research Impact of COVID-19
• Halloran Consulting Group
  • Adjusting to Remote Monitoring During COVID-19: Working Smarter & Safer Lessons Learned from a Virtual Town Hall held on April 3, 2020
• ICON
  • Coronavirus Observatory
• Johns Hopkins University
  • COVID-19 Research Response (guidance & communications)
  • Research: Human Subject Research Contingency Plan – Phase 2
• TrialHub
  • Resource Hub COVID-19
• WIRB-Copernicus Group
  • Resource Center: COVID-19 and Clinical Trial Operations

Good Research Practices

Investigational Medical Products, Pharmaceutics

• Drugs.com
  • COVID-19: Prevention & Investigational Treatments
• University of Liverpool
  • COVID-19 Drug Interactions

Outcomes

• COVID-19 Core Outcomes – An international initiative to establish critically important core outcomes for trials in COVID-19

Society for Clinical Research Sites (SCRS)

• SCRS Calls on Sponsors to Release Holdback Funds in Response to COVID-19 (2 April 2020).
• SCRS COVID-19 Resource Center

Vaccine development

• News and publications
  • Covid-19 vaccine tracker updated to include GSK/Sanofi collaboration (16 April 2020). Endpoints News.
  • The COVID-19 vaccine development landscape (9 Apil 2020). Nature Reviews Drug Discovery.
  • COVID-19 Vaccine Frontrunners (7 April 2020). The Scientist.
  • Ton de Boer (CBG) over sneller traject vaccinontwikkeling (7 April 2020). Vereniging Innovatieve Geneesmiddelen.
    • Sprankje hoop op snel coronavaccin (6 April 2020). BNR
  • Scientists Rush to Find Coronavirus Cure—but It Still Isn’t Fast Enough (6 April 2020). The Wall Street Journal.
  • GlaxoSmithKline and Vir aim to take on Covid-19 with antibodies and CRISPR (6 April 2020). STAT.
  • BioNTech, CureVac tell regulators to lower clinical trial bar if they want a COVID-19 vaccine quickly (3 April 2020). Fierce Biotech.
  • The world must devise a globally fair covid-19 vaccine allocation system (3 April 2020). The Economist.
  • Update on treatments and vaccines against COVID-19 under development (31 March 2020). EMA.
  • Developing Covid-19 Vaccines at Pandemic Speed (30 March 2020). NEJM.
  • ‘It’s a razor’s edge we’re walking’: inside the race to develop a coronavirus vaccine (27 March 2020). The Guardian.
  • Should scientists infect healthy people with the coronavirus to test vaccines? (26 March 2020). Nature.
  • COVID-19 vaccine & therapy research boosted by six new projects in rapid response (23 March 2020). Medical Research Council.
  • The Risky Race for a Quick Coronavirus Vaccine (16 March 2020). The New Republic.
  • Everything You Need to Know About Coronavirus Vaccines (4 March 2020). Wired.
• Services
  • Eatris / TRANSVAC: Services to COVID-19 vaccine developers

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Biobanking, Patient Registries

BBMRI

• BBMRI-ERIC
  • BBMRI-ERIC Directory (biobank explorer)
  • BBMRI-ERIC response to the coronavirus pandemic. Resources from biobanks across Europe available for research on COVID-19 (updated 6 April 2020).
  • BBMRI-ERIC response to COVID-19: Resources from biobanks across Europe available for research on COVID-19. BBMRI-ERIC, via LinkedIn.
• BBMRI.de – German Biobank Node (GBN)
  
  • Covid-19: Gemeinsam gegen das Coronavirus
  • Covid-19: Arbeiten mit SARS-CoV-2-Proben
•  BBMRI.it
  • Biobancare per la ricerca COVID-19
• BBMRI.nl
  • BBMRI.nl Catalogue: COVID 19
  • BBMRI.nl: Catalogue – Collections

Biosafety

• Biosafety Level Guidance for COVID-19 Research (31 March 2020). Consolidated Sterlizer Systems.

Biosample Hub

• Biosample Hub, For research, not-for-profit

COPP studie

• COPP studie: Landelijke registratie studie naar COVID-19 bij kinderen

COVIDPredict

• COVIDPredict

Guidance biobanking and biospecimines

• CDC – Guidelines
  • Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
  • Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
• University of California San Francisco: COVID-19 Biospecimen Guidelines (15 March 2020).
• WHO – Guidance
  • Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus: interim guidance (2 March 2020).
  • Laboratory testing for coronavirus disease (‎‎COVID-19)‎‎ in suspected human cases: interim guidance, (19 March 2020)
  • Laboratory biosafety guidance related to coronavirus disease (‎COVID-19)‎: interim guidance (19 March 2020)
  • Laboratory testing of human suspected cases of novel coronavirus (‎‎‎‎‎‎‎‎nCoV)‎‎‎‎‎‎‎‎ infection: interim guidance (10 January 2020)
• Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial (3 April 2020). Journal of Empirical Research on Human Research Ethics.

International Society for Biological and Environmental Repositories (ISBER).

• COVID-19 Discussion and Information Series

Lifelines

• Lifelines: ruim 60 procent ouderen bezorgd ziek te worden van coronavirus (10 April 2020). Dagblad van het Noorden.
• Groot onderzoek gestart naar risicofactoren coronavirus (30 March 2020).

UKCRC Tissue Directory and Coordination Centre

• How is COVID-19 affecting UK biobanking?
• Response to COVID-19

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Patient Registries, Artificial Intelligence, Data management, Datasets

Artificial Intelligence/Kunstmatige Intelligentie

• Gezien bij Op1: Paul Elbers over de inzet van AI tegen COVID-19 (25 March 2020). Vincent Bontrop (website/blog).
• Towards an Artificial Intelligence Framework for Data-Driven Prediction of Coronavirus Clinical Severity (30 March 2020). Tech Science Press.
• Mapping the Landscape of Artificial Intelligence Applications against COVID-19 (25 March 2020). arXiv:2003.11336 [cs.CY].
• AI en covid-19: Een pandemie mag geen excuus zijn voor ‘function creep’ (26 March 2020). Kenniscentrum Data & Maatschappij.
• Ethics of Using and Sharing Clinical Imaging Data for Artificial Intelligence: A Proposed Framework (24 March 2020). Radiology.
• Responsible AI in times of pandemic (20 March 2020). Virginia Dignum, via LinkedIn.
• To fight the coronavirus pandemic effectively we need lots more data (18 March 2020). New Scientist.
• Phones Could Track the Spread of Covid-19. Is It a Good Idea? (15 March 2020). Wired.
• How Artificial Intelligence is Aiding the Fight Against Coronavirus (13 March 2020). Center for Data Innovation.
• How digital humanities can help in a pandemic (20 March 2020). EPFL.
• Machine learning and artificial intelligence research for patient benefit: 20 critical questions on transparency, replicability, ethics, and effectiveness BMJ 2020; 368 :l6927.

ASH RC COVID-19 Registry for Hematologic Malignancy

• ASH RC COVID-19 Registry
• ASH Research Collaborative Data Hub Launches COVID-19 Registry for Patients with Hematologic Malignancies (4 April 2020). Trial Site News.

AWS Cloud

• A public data lake for analysis of COVID-19 data (8 April 2020).
• AWS COVID-19 data lake

CAPACITY registry

• European registry of patients with COVID-19 including cardiovascular risk and complications.

Covid19 Challenge.eu

• Covid19Challenge.eu – A platform for open research on large Covid-19 imaging datasets

COVID-evidence

• COVID-evidenc: continuously updated database of the worldwide available evidence on interventions for COVID-19.

COPP Studie

• COPP Studie: landelijke registratie studie naar COVID-19 bij kinderen

Data Archiving and Networked Services (DANS)

• NARCIS biedt wetenschappelijke informatie over corona en aanverwant onderzoek

Data management

• COVID-19 & Risk-areas and potential impact to clinical data. SCDM.
• COVID-19 | Data Management| Impact on Clinical Database & DMPs (19 March 2020). David Edghill, via LinkedIn.
• Making data on COVID-19 available to the scientific community (7 April 2020). Universiteit Utrecht.
• Working safely with research data from home (n.d.). Universiteit Utrecht.

Data Networks and research

• ELIXIR’s services to support COVID-19 research (24 March 2020).
• ELIXIR support for SARS-CoV-2 research
  As the ESFRI Research Infrastructure for life science data, ELIXIR Nodes provide a range of services that can be used by researchers and consortia working on SARS-CoV-2 research.
• GO FAIR Foundation: Virus Outbreak Data Network (VODAN)
  • ZonMw: Start datanetwerk coronavirus (13 March 2020).
• Hohns Hopkins CSSE: 2019 Novel Coronavirus Visual Dashboard (data repository in GitHub).
• Health Data Research UK: Coronavirus (COVID-19) Useful Resources (GitHub)
• Kaggle: Help us better understand COVID-19
• Kaggle: COVID-19 Open Research Dataset Challenge (CORD-19)
  An AI challenge with AI2, CZI, MSR, Georgetown, NIH & The White House
• Medium – Towards data science: 5 Datasets About COVID-19 you can Use Right Now (27 March 2020).
• Tableau: COVID-19 Data Hub
  • How Tableau is making real-time COVID-19 data accessible to everyone (27 March 2020). TechRepublic.
• US Office of Science and Technology Policy: Call to Action to the Tech Community on New Machine Readable COVID-19 Dataset (16 March 2020).

Data sharing

• Prediction models for diagnosis and prognosis of covid-19 infection: systematic review and critical appraisal 7 April 2020). BMJ 2020;369:m1328.

… Immediate sharing of well documented individual participant data from covid-19 studies is needed for collaborative efforts to develop more rigorous prediction models and validate existing ones. …
–BMJ 2020;369:m1328

Electronic Data Capturing

• Mitigating the impact of COVID-19 on clinical research (7 April 2020). Castor EDC.
• Castor launches COVID-19 monitoring and research platform, and is supporting over 100 trials globally (2 April). Castor EDC.
• Castor EDC: Castor vs. the Coronavirus (COVID19) (13 February 2020). Castor EDC.

Castor has joined the global fight against the Coronavirus by making our research data capture platform available for free for all non-profit COVID19 research projects. We have developed ready for use eCRFs based on the WHO standard CRFs, to help researchers start their study or registry in less than an hour. The lack of quality data should not be the reason for a delay in finding a cure.
– Derk Arts, 13 February 2020

• How REDCap is being used in response to COVID-19 (n.d.). REDCap.

EMBL-EBI

• COVID-19 Data Portal
• European COVID-19 Data Platform

Imaging COVID-19 AI initiative

• Imaging COVID-19 AI initiative

Indian Institute of Technology Kharagpur

• COVID-19 Action Group on AI and Radiology

Lean European Open Survey on SARS-CoV-2 Infected Patients

• LEOS: Studying SARS-CoV-2 in European patients
• COVID-19: Set Up of European Registry for Coronavirus Patients (19 March 2020). German Center for Infection Research (DZIF).

Nationale Intensive Care Evaluatie (NICE)

• COVID-19 infecties op de IC’s
• COVID-19 infecties op de verpleegafdeling
• COVID-19 Rapport Patiëntkarakteristieken en uitkomsten (14 April 2020).

Observational Health Data Sciences (OHDSI)

• COVID-19 Updates Page
• Researchers hold ‘study-a-thon’ to tackle COVID-19 (22 April 2020). Outsourcing Pharma com.

Publications Office of the European Union

• EU Datathon – The Coronavirus pandemic

Secure Collective Covid-19 Research

• Secure Collective Covid-19 Research

Society of Critical Care Medicine (SCCM) – VIRUS

• Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry and Validation of Critical Care Data Dictionary (C2D2) (VIRUS study). Prospective, cross-sectional, observational study and registry.

Trackers & maps

• John Hopkins University: Map of global infections
• STAT: The Covid-19 Tracker
• Worldometer: COVID-19 Coronavirus Pandemic

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Resources

Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)

• NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options (17 April 2020). NIH.
• Secretary Azar Statement on New Partnership to Develop National Strategy for COVID-19 Therapies and Vaccines (17 April 2020). HHS.
• NIH partners with 16 drug companies in hopes of accelerating Covid-19 treatments and vaccines (17 April 2020). STAT.

Animal research

• Public attitudes to animal research under COVID-19 Survey report (April 2020). Understanding Animal Research, London.
• The NC3Rs and the 3Rs during COVID-19 (3 April 2020). National Centre for the Replacement & Reduction of Animals in Research.
• Proefdiervrij: Corona en dierproeven
• Norecopa
  • COVID-19 pandemic. Be Prepared.
  • Newsletter no. 4-2020 from Norecopa (17 June 2020)
  • Newsletter 3-2020 (27 April)

API (application programming interface)

• APIs to Track Coronavirus COVID-19 (24 April 2020). ProgrammableWeb.

Center for Open Science

• Center for Open Science. Coronavirus Outbreak Research Collection.
• COS homepage
• COS Search term ‘covid-19’

Courses, Educative, Training

• COVID-19: What You Need to Know
• DIA: Now In Focus: COVID-19
• Imperial College London & Coursera: Free COVID-19 online course re-launches to learners worldwide.
• JoVE: Coronavirus Free Access Resource Center
• London School of Hygiene & Tropical Medicine: Future Learn – COVID-19: Tackling the Novel Coronavirus
• Personal Health Train: Personal Health Train will help research on viral outbreaks (16 March 2020).

Collaboration

• ResilientSociet: Co-creation platform for the COVID-19 crisis.

Researchers, care professionals, the manufacturing industry and governments are actively seeking each other out to bring society’s urgent and long-term supply and demand together. We all aim to do this effectively without duplicating our efforts, and with the aim of making the greatest possible impact. To meet that need, Dutch universities, national and regional governments, businesses and many more public and private partners are launching the ResilientSociety platform. – About ResilientSociety

Communication and digital solutions, GDPR

• ICT & health
  • Overzicht Oplossingen
• NHG
  • Corona – inzet van digitale communicatiemiddelen en applicaties
• Siilo
  • How Users are Working with Siilo to Address Covid-19
• Signal
  • Signal, for messages and calls
• SURF (SURFfile sender)
  • Coronavirus and SURF
  • COVID-19 Fast Track for Computing Time Call (30 March 2020). 
  • Persoonlijke cloudopslagdienst voor het Nederlandse onderwijs en onderzoek
• Privacy cheat sheet (7 April 2020). Nuno Lima da Luz, via LinkedIn.
• What You Should Know About Online Tools During the COVID-19 Crisis (19 March 2020). EFF.

#CoronavirusSyllabys (on Twitter)

• #CoronavirusSyllabus at Twitter
• #coronavirussyllabus at Google Docs
   a crowdsourced cross-disciplinary resource (open access)

Covid-19, Coronavirus disease 2019

• DynaMed: COVID-19 (Novel Coronavirus).
• Coronavirus disease 2019 (COVID-19): Epidemiology, virology, clinical features, diagnosis, and prevention. UpToDate.

Diagnostics, Genomics, Viral strains

• COVID-19 Beacon – The COVID-19 Beacon is a service that enables discovery of genetic variants that have been identified in genomes of the COVID-19 virus and associated information (e.g. location). 
• GenBank: SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) Sequences
• Icahn School of Medicine at Mount Sinai – The Krammer Laboratory: COVID-19
• Nextstrain: Genomic epidemiology of novel coronavirus
• Public Health Alliance for Genomic Epidemiology (PHA4GE)
• Terra: Broad scientists release COVID-19 best-practices workflows and analysis tools in Terra (18 March 2020).
• Terra: COVID-19 workspaces, data and tools in Terra (17 March 2020).
• The COVID-19 Host Genetics Initiative

Ethiek

• The ethics of conducting clinical trials in the search for treatments and vaccines against COVID-19 (21 April 2020). Faculty of Pharmaceutical Medicine.
• Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I) (10 April 2020). Bill of Health, Petrie-Flom Center at Harvard Law School.
• Beyond liberty: social values and public health ethics in responses to COVID-19 (26 March 2020). Nuffliec Council of Bioethics.
• The Hastings Center
  • Equitably Sharing the Benefits and Burdens of Research: Covid‐19 Raises the Stakes (14 May 2020). Ethics & Human Research.
  • Ethics Resources on the Coronavirus (COVID-19).

Good Manufacturing Practice

• COVID-19 Pandemic and Your GMP Audit Schedule for 2020 (20 March 2020). Govzilla.

Hacking Health

• Dutch Hacking Health: Hack Corona!

High Ambiguity Driven protein-protein DOCKing (HADDOCK)

• HADDOCK to support COVID-19 research (6 April 2020).

Infectious Diseases Data Observatory

• Living systematic review COVID-19
• A Living Systematic Review Protocol for COVID-19 Clinical Trial Registrations (2 April 2020). Wellcome Open Res. 2020;5:60.

Internet Book of Critical Care (IBCC)

• IBCC COVID-19.

Medical Devices

• Forum MedTech Pharma : Covid-19 Portal
• Is de corona app een medisch hulpmiddel (26 April 2020). Quality Business Support Blog.
• Communication from the Commission Guidelines on COVID-19 in vitro diagnostic tests and their performance (15 April 2020). European Commission.

OpenAIRE

• OpenAIRE for COVID-19 (6 April 2020).

Open Knowledge Foundation

• Coronavirus: why an open future has never been more important (16 April 2020).
• Supporting the Open COVID Pledge (9 April 2020).
• Staying open: how we will continue our work despite COVID-19 (19 March 2020).

RADAR-CNS

• Impact of the COVID-19 pandemic on RADAR-CNS (20 April 2020).

Research output

• Annals of Internal Medicine COVID-19
• bioRxiv & medRxiv: COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv
• British Medical Journal COVID-19
• Cell COVID-19
• eLife: Peer Review: Publishing in the time of COVID-19
• Elsevier: Novel Coronavirus Information Center
• EPPI-Centre: Evidence Map COVID-19
• Figshare: COVID-19 research data
• Google Scholar search strategy
• Infectious Diseases Data Observatory: Living systematic review COVID-19
• JAMA Network COVID-19
• Journal of Medical Virology COVID-19
• Liebert portfolio: Coronavirus Highlights Urgent Need for Science-Backed Research
• LitCovid: Curated literature hub for tracking up-to-date scientific information about the 2019 novel Coronavirus
• L·OVE: Coronavirus – COVID-19
• Medisch Contact COVID-19
• Nederlands Tijdschrift voor Geneeskunde COVID-19
• New England Journal of Medicine COVID-19
• NIH: Disaster Lit search strategy
• NIHR Innovation Observatory: COVID-19 Updates
• Open Access.nl: Open Access voor COVID-19 en gerelateerd onderzoek.
• Preprints COVID-19
• PubMed search strategy
• ResearchGate: Combating COVID-19
• RSNA Journal: Special Focus – COVID-19
• Science Open: COVID-19 resources on ScienceOpen: Find and share research outputs (17 March 2020).
• Semantic Scholar: CORD-19 Discourse
• Semantic Scholar: Your First Research Feed
• The Allen Institute for Artificial Intelligence: The CORD-19 explorer is a full-text search engine for the COVID-19 Open Research Dataset.
• The Allen Institute & Semantic Scholar: COVID-19 Open Research Dataset (CORD-19)
• The Allen Institute: CoViz
  • CoViz: Helping scientists visualize and explore COVID-19 literature with AI (3 April 2020). Medium.
• The Lancet COVID-19
• Trials: COVID-19 randomised trial protocols: rapid publication without barriers
• Trip medical database
• Twitter: Search results #CORD19

Resources

• COVID-19-Research: Researcher Resources

Social Sciences and Humanities, Expertise

• COVID-19 Social Science Research Tracker (GitHub).
• SSH & COVID-19

SSH COVID-19 portal aims to consolidate and organize the SSH expertise across the Dutch universities in a publicly available national portal, ensuring fast and direct access to academic experts.
– Bron: SSH

TrialForge

• Resource collection– COVID-19 trial participant information leaflets and consent forms (ID RC2) – Trial Forge.
• Resource Collection– Plain language COVID-19 glossary (ID RC1) – Trial Forge.
• Video– Predicting trial site recruitment in COVID-19 and other trials – Trial Forge.

Updates

• Cafepharma
• Clinical Informatics Research Unit: R&D Data & Dashboard to support the COVID-19 pandemic response
• NTvG: Dossier COVID-19
• Science Business: LIVE BLOG: R&D response to COVID-19 pandemic
• WHO EIOS: Coronavirus news as reported through publicly available web sites

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Grants, Funding

• EuropeBio:Funding Opportunities for biotech in the fight against COVID-19.
• ECRIN: Funding Calls
• National Health and Medical Research Council (NHMRC): COVID-19 impacts
• National Institutes of Health (NIH): Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding.
• NWO: Maatregelen rondom coronavirus
• Wellcome: Sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak (31 January 2020).
• ZonMw
  • Coronavirus
  • Belangrijkste maatregelen.
  • Onderzoek naar corona en COVID-19

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Webinars

Past webinars

• RSNA: Radiology Preparedness for COVID-19: Radiology Scientific Expert Review Panel (18 March 2020).
• Brookwood Global: Ways to Manage Clinical Trial Challenges in a Pandemic Period (25 March 2020). (download slides/notes)
• Castor EDC: Webinar: Research Continuity During COVID-19 (27 March 2020).
• Clinical Trials Transformation Initiative: Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic (31 March 2020). (Download slides/notes)
• Clinipace – Business Continuity: GCP Compliant Clinical Trials (31 March 2020).
• RQA Webinar: COVID-19 ‘GxP Insights on Building Resilience and Agility’ (31 March 2020).
• BBMRI.QM : Web conference – Biobanking in times of COVID-19: Risks and Opportunities for Biobanks (1 April 2020).
• GCP Central: Live Webinar ‘Clinical trials during corona – a risk-based approach in the interest of patients and data’ (2 April 2020).
• Imaging COVID-19 AI project: Using AI with CT images to diagnose COVID-19 – AI Suisse (3 April 2020).
• Nuffield Council of Bioethics: Ethics in the research response to COVID-19 (3 April 2020).
• Syneos Health: Implementing Remote Clinical Trial Monitoring to Ensure Continuity of Trials and Data Preservation – While Keeping Patients Safe (3 April 2020).
• ISBER: Understanding COVID-19 Webinar (7 April 2020).
• GCP Central: Live Webinar ‘Clinical trials in tijden van corona: een gerichte aanpak in het belang van patiënt en data” (7 April 2020).
• Pharmaphorum & ERT: webinar Vaccines trials in the era of COVID-19 – balancing study speed, accuracy and patient experience (8 April 2020).
• EC, HMA & EMA: Webinaron the Guidance on the management of clinical trials during the COVID-19 pandemic (15 May 2020).

Missing important links or found any broken links? Please use this form to report broken/missing links.

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Other news

The news feed below is no longer updated. For more news, please visit news.bontrop.com

2 July 2020

• Global scientific community unites to track progress on COVID-19 R&D, identifies new research priorities and critical gaps (2 July 2020). WHO.
• One U.K. trial is transforming COVID-19 treatment. Why haven’t others delivered more results? (2 July 2020). Science.

1 July 2020

• International regulators provide guiding principles for COVID-19 clinical trials (1 July 2020). EMA.
• FDA says COVID-19 vaccine would need to be at least 50% effective to be approved (1 July 2020). Pharmafile.
• FDA will not ‘cut corners’ in assessing Covid-19 vaccines, commish says (1 July 2020). MedCity News.
• Covid-19 has roiled clinical trial plans around the world, raising concerns over the industry’s future on new drug approvals (1 July 2020). Endpoints News.

30 June 2020

• Inovio claims positive results on Covid-19 vaccine but critical data are missing (30 June 2020). STAT.
• Top European hospitals deny providing data for retracted Covid-19 research (30 June 2020). POLITICO.
• Here’s what we’ve learned in six months of COVID-19 — and what we still don’t know (30 June 2020). Science News.

29 June 2020

• Covid-19 and the long history of ignoring women in medical research (29 June 2020). The Guardian.
• Accepting the Challenge: Covid Vaccine Challenge Trials Can Be Ethically Justified (29 June 2020). The Hastings Center.
• Advocacy Group Worries European COVID-19 Trials Won’t Publish Results (29 June 2020) WCG CenterWatch.
• Coronacrisis versnelt onderzoek, ook als het niets met corona te maken heeft (29 June 2020). Medisch Contact.
• New journal will vet Covid-19 preprints, calling out misinformation and highlighting credible research (29 June 2020). STAT.

27 June 2020

• The Lancet Editor’s Wild Ride Through the Coronavirus Pandemic (27 June 2020). The New Yorker.

26 June 2020

• Green light for COVID-19 trial recruitment (26 June 2020). MHRA.
• Covid-19 vaccine research must involve Black and Latinx participants. Here are 4 ways to make that happen (26 June 2020). STAT.

24 june 2020

• Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines (24 June 2020). EMA.

23 June 2020

• Pandemic publishing poses a new COVID-19 challenge (23 June 2020). Nature Human Behaviour.

22 June 2020

• How is COVID-19 impacting the rare disease community? (22 June 2020). Pharmafile.

20 June 2020

• Sanquin begint met verzamelen plasma voor mogelijk geneesmiddel coronavirus (20 June 2020). Ministerie van Volksgezondheid, Welzijn en Sport.

19 June 2020

• FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency (19 June 2020). LexBlog.

18 June 2020

• International regulators stress value of safe and effective vaccines (18 June 2020). EMA.
• FDA joins new, public-private COVID-19 diagnostic research accelerator effort (18 June 2020). Fierce Biotech.
• Scientists Take Aim at Another Coronavirus Study in a Major Journal (18 June 2020). The New York Times.
• Public Health on Call 097 – Retractions of COVID-19 Research Papers: How the Race to Find Treatments Could Mean Sloppy Science (18 June 2020). Johns Hopkins.

17 June 2020

• Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again? (17 June 2020). STAT.
• WHO drops hydroxychloroquine from Covid-19 clinical trial (17 June 2020). STAT.
• What Patients Expect from Clinical Trials in the COVID-19 Era (17 June 2020). Applied Clinical Trials.

16 June 2020

• ‘We have suspends recruitment to COVID-19 hydroxychloroquine trials (16 June 2020). MHRA.
• Immune status could determine efficacy of COVID-19 therapies (16 June 2020). Nature Reviews Drug Discovery.

15 June 2020

• Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4 (15 June 2020). EMA.
• How Did This Pass Peer Review? Thoughts on the Lancet and NEJM COVID-19 Retractions (15 June 2020).Medscape.
• COVID-19: UK and Europe life sciences regulatory developments (15 June 2020). Pharmafile.

10 June 2020

• EMA issues guidance on remote GCP inspections (10 June 2020). Regulatory Focus.
• Retracted COVID-19 studies expose holes in vetting of data firms (10 June 2020). Reuters.

8 June 2020

• COVID-19 vaccines start moving into advanced trials (8 June 2020). Nature Reviews Drug Discovery.
• First antibody against COVID-19 spike protein enters phase I (8 June 2020). Nature Reviews Drug Discovery.

5 June 2020

• Flexibility Touted as Key to Success for Research Professionals in Post COVID-19 Workforce (5 June 2020). ACRP, Blog.

4 June 2020

• Author of Two Retracted COVID-19 Studies Once Bemoaned Misconduct (4 June 2020). Medscape.
• Lancet, NEJM retract controversial COVID-19 studies based on Surgisphere data (4 June 2020). Retraction Watch.

3 June 2020

• Resultaten DCRF enquête over klinisch onderzoek tijdens COVID-19 bekend (3 June 2020). ACRON.

1 June 2020

• How You Should Read Coronavirus Studies, or Any Science Paper (1 juni 2020). The New York Times.

28 May 2020

• Principles for Clinical Studies into COVID-19 (28 May 2020). Faculty of Pharmaceutical Medicine.
• Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity. JAMA. Published online May 28, 2020.
• Goedkeuring nieuwe medicijnen sneller door het coronavirus? (28 May 2020). PGO Support.

27 May 2020

• EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines (27 May 2020). EMA.
• UMC Utrecht and Utrecht University will lead European project. Monitoring the benefits and safety of the new corona vaccines (27 May 2020). Universiteit Utrecht.
• COVID-19 Pandemic Readiness: Let’s not reinvent the wheel – European Medical Research Infrastructures are part of the global response (27 May 2020). Euractiv.

26 May 2020

• EMA strengthens ENCePP mandate to address COVID-19 pandemic (26 mei 2020). Regulatory Focus.
• EMA calls for high-quality observational research in context of COVID-19 (26 May 2020). EMA.
• Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust. JAMA. Published online May 26, 2020.

20 may 2020

• Global regulators commit to cooperate on observational research in the context of COVID-19 (20 May 2020). EMA.

19 May 2020

• Zorgvisie: ‘Klinisch onderzoek viel rigoureus stil bij corona-uitbraak’ (19 May 2020). Vereniging Innovatieve Geneesmiddelen.
• Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies (19 May 2020). JAMA Intern Med.

18 May 2020

• FDA updates COVID-19 clinical trials guidance to address serious adverse events (18 May 2020). Regulatory Focus.
• Data Safety Monitoring during Covid‐19: Keep On Keeping On (18 May 2020). Ethics & Human Research.
• Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet (18 May 2020). Clinical Trials Transformation Initiative.

15 may 2020

• International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials (15 May 2020). EMA.

14 May 2020

• Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity? (14 May 2020). Clinical Pharmacology & Therapeutics.
• Covid-19 roundup: Counting 1,087 trials for coronavirus, R&D experts say much of it is a complete waste; WHO scientist portends it will be ‘years’ before Covid-19 threat will be contained (14 May 2020). Endpoints News.

13 May 2020

• Where’s the data? In a pandemic, now is no time to sit on Covid-19 trial results (13 Mary 2020). STAT.

11 May 2020

• Inside the NIH’s controversial decision to stop its big remdesivir study (11 May 2020). STAT.

8 May 2020

• The ​University of Iceland uses SMART-TRIAL and eConsent to uncover the impacts of COVID-19 on a modern society (8 May 2020). SMART-TRIAL.
• Building An Infrastructure for High-Quality Clinical Trials (8 May 2020). Combacte.
• The U.S. government contributed research to a Gilead remdesivir patent — but didn’t get credit (8 May 2020). STAT.

7 May 2020

• Autopsy slowdown hinders quest to determine how coronavirus kills (7 May 2020). Nature.
• EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19 (7 May 2020). Arnold & Porter, BioSlice Blog.
• Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19) (7 May 2020). Jama Pediatrics.

6 May 2020

• ‘It will not be easy.’ As labs begin to reopen, enormous challenges remain (6 May 2020). Science.
• China is promoting coronavirus treatments based on unproven traditional medicines (6 May 2020) Nature.
• Mounting promises on Covid-19 vaccines are fueling false expectations, experts say (6 May 2020). STAT.
• ‘We’re all in this together’ – what does this mean for COVID-19 research? (6 May 2020). Nuffield Council of Bioethics.

5 May 2020

• Efforts to beat back the coronavirus are critical. They’re also making clinical trials harder (5 May 2020). STAT.
• Were researchers wrong to move the goalposts on remdesivir? In the end, it may not have mattered (5 May 2020). STAT.

4 May 2020

• COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines (4 May 2020). EMA.
• EMA details rapid procedures for COVID-19 products (4 May 2020). Regulatory Focus.
• Covid-19 has shuttered scientific labs. It could put a generation of researchers at risk (4 May 2020). STAT.

2 May 2020

• CROs Move to Digital Clinical Trials Due to Constraints of COVID-19 Pandemic: PPD’s Story (2 May 2020). Trial Site News.
• Dutch Researchers Confirm that SARS-CoV-2 Infects the Intestine (2 May 2020). Trial Site News.

1 May 2020

• As Covid-19 Research Raises Hopes, Experts Urge Caution (1 May 2020). Undark.
• Pressure Is Mounting on Regulators as Covid-19 Drug Efforts Race Ahead (1 May 2020). Barron’s.
• Coronavirus in context: Scite.ai tracks positive and negative citations for COVID-19 literature (1 May 2020). Nature.

30 April 2020

• Regulatory and Ethics Perspective on COVID-19 Data Sharing (30 April 2020). Global Alliance for Genomics and Health.
• Coronacrisis zorgt voor omslag: van data delen naar data raadplegen (30 April 2020). Zorgvisie.
• Urgentielijst kan datalacunes niet vullen (20 April 2020). Skipr.

29 April 2020

• The COVID-19 pandemic is influencing consumer health behavior. Are the changes here to stay? PwC Health Research Institute.
• “Following the science” in the COVID-19 pandemic (29 April 2020). Nuffield Council of Bioethics.

28 April 2020

• Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU (28 April 2020). European Commission.
• Science Has an Ugly, Complicated Dark Side. And the Coronavirus Is Bringing It Out. (28 April 2020). Mother Jones.

27 April 2020

• Pseudoscience and COVID-19 — we’ve had enough already (27 April 2020). Nature.
• Scientists who express different views on Covid-19 should be heard, not demonized (27 April 2020). STAT.

26 April 2020

• Germany’s Covid-19 expert: ‘For many, I’m the evil guy crippling the economy’ (26 April 2020). The Guardian.

25 April 2020

• Artsen bezorgd over gebruik urgentielijst als triagemiddel (25 April 2020). Skipr.

24 April 2020

• Ethical collection of data from children during the COVID-19 pandemic (24 April 2020). Unicef.
• Open science takes on the coronavirus pandemic (24 April 2020). Nature.
• Chinese state censorship of COVID-19 research represents a looming crisis for academic publishers (24 April 2020). The London School of Economics and Political Science.
• A real-time dashboard of clinical trials for COVID-19 (24 April 2020). The Lancet.
• Chloroquine hype is derailing the search for coronavirus treatments (24 April 2020). Nature.
• New Normal? Takeaways from A Virtual Regulatory Inspection During COVID-19 (n.d.). DIA Global.
• A Stanford Professor’s Wife Recruited People For His Coronavirus Study By Claiming It Would Reveal If They Could “Return To Work Without Fear” (24 April 2020). Buzzfeed.
• WHO launches ambitious global project to develop Covid-19 medical products (24 April 2020). STAT.
• Why was an obscure federal bureaucrat involved in Trump’s emergency hydroxychloroquine authorization? (24 April 2020). STAT.
• Eli Lilly execs have been thinking about the longterm effects of the pandemic and damage control. Here’s what they believe (24 April 2020). Endpoints News.
• Advice for the worried (24 April 2020). Science.
• European countries wary about confronting China over COVID-19 death figures (24 April 2020). Pharmafile.
• Recon: Gilead disputes report remdesivir flopped in first trial; WHO launches COVID-19 development initiative (24 April 2020). Regulatory Focus.

23 April 2020

• Electronic Informed Consent in Mobile Applications Research. The Journal of Law, Medicine & Ethics, 48(1_suppl), 147–153.
• Consent in the time of COVID-19 (23 April 2020). Blog, Journal of Medical Ethics.
• COVID-19: Research professionals over de gevolgen, implicaties en kansen (23 April 2020). Vincent Bontrop.
• Against pandemic research exceptionalism (23 April 2020). Science.
• A Number Of Coronavirus Studies Are Now Being Released. How Do We Gauge Their Validity? (23 April 2020). AirTalk.
• New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope (23 April 2020). STAT.
• ‘It’s noisy’: Competing Covid-19 efforts could hamper progress, experts warn (23 April 2020). STAT.
• ‘Het kankeronderzoek ligt goeddeels stil’ (23 April 2020). NRC.

22 April 2020

• Pandemic Pandemonium: Pausing Clinical Research During the COVID-19 Outbreak (22 April 2020). Circulation.
• Hundreds of people volunteer to be infected with coronavirus (22 April 2020). STAT.
• People are dying from coronavirus because we’re not fast enough at clinical research (22 April 2020). STAT.
• The purpose of publications in a pandemic and beyond (22 April 2020). Wonkhe.
• Sweden Health Agency Withdraws Controversial Coronavirus Report (22 April 2020). Forbes.
• UPDATED: Deposed BARDA chief blasts Trump administration on promoting unproven drugs as Covid-19 panacea: ‘Science — not politics or cronyism — has to lead the way’ (22 April). Endpoints News.
• An ousted vaccine agency director offers an explosive, direct allegation: Trump is politicizing science (22 April 2020). STAT.
• Ousted vaccine expert battles with Trump team over his abrupt dismissal (22 April 2020). POLITICO.
• Coronavirus updates: autopsy results drastically change US coronavirus timeline (22 April 2020). Nature.
• Why the World Bank ex-chief is on a mission to end coronavirus transmission (22 April 2020). Nature.

21 April 2020

• How To Transition To A Remote Clinical Trial (21 April 2020). Compliance in Focus, IMARC Research.
• Mike Clarke: How can we avoid research waste during the covid-19 pandemic and plan for the future? (21 April 2020). The BMJ Opinion.
• Coronavirus Is Forcing Medical Research to Speed Up (21 April 2020). The New York Times.
• NIH Director Francis Collins on Tony Fauci, the WHO, and running a $39 billion research agency from home (23 April 2020). STAT.
  

20 April 2020

• How scientists can volunteer to help fight COVID-19 (20 April 2020). Biotechnology Community.
• Everything we know about coronavirus immunity and antibodies — and plenty we still don’t (20 April 2020). STAT.
• Managing a pharma company during three crises: lessons learned for Covid-19 (20 April 2020). STAT.

19 April 2020

• Biobanks, Industry and the Covid-19 Pandemic (19 April 2020). Robert Hewitt, via LinkedIn.

17 April 2020

• How Not to Lose the COVID-19 Communication War (17 April 2020). Slate.
• UPDATED: NIH corrals biopharma companies, regulators and trial networks to coordinate Covid-19 R&D (17 April 2020). Endpoints News.
• Østens visdom (n.d.). Weekendavisen.
• How research funders are tackling coronavirus disruption (17 April 2020). Nature.
• How does coronavirus kill? Clinicians trace a ferocious rampage through the body, from brain to toes (17 April 2020). Science.
• Wat maakt dit coronavirus zoveel gevaarlijker dan zijn voorgangers? (17 April 2020). NRC.

16 April 2020

• Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data (16 April 2020). EMA.
• How is biomedical research funding faring during the COVID-19 lockdown? (16 April 2020). Nature Medicine.
• Finding Effective Treatments for COVID-19: Scientific Integrity and Public Confidence in a Time of Crisis. JAMA. Published online April 16, 2020.
• Harvard profs maintain that the FDA’s recent actions on Covid-19 devalue the gold standard and threaten public trust (16 April 2020). Endpoints News.
• Coronavirus clue? Most cases aboard U.S. aircraft carrier are symptom-free (16 April 2020). Reuters.
• On the front lines of the coronavirus-vaccine battle (16 April 2020). Nature.

15 April 2020

• China is tightening its grip on coronavirus research (15 April 2020). Nature.
• Boosting the arsenal against COVID-19 through computational drug repurposing (15 April 2020). Drug Discovery Today.
• The Wild Wild West of COVID-19 Testing Products: Are Shoddy Antibody Testing Products Getting Past FDA? (15 April 2020). TrialSite News.
• Major League Baseball Joins The Fight Against Coronavirus In A Big Way (15 April 2020). NPR.
• Promoveren in tijden van corona (15 April 2020). ScienceGuide.

14 April 2020

• SRTI, Stanford Health Launch mHealth Consortium for COVID-19 Research (14 April 2020). mHealth Intelligence.
• COVID19: Serology is harder than it looks (14 April 2020). Drug Baron.
• Coronavirus Tests Science’s Need for Speed Limits (14 April 2020). The New York Times.

Unfortunately people in times of crisis forget that science is a proposition and a conversation and an argument. I know everybody’s desperate for absolute truth, but any scientist will say that’s not what we’re dealing with.
– Ivan Oransky

• Rapid Registered Reports initiative aims to stop coronavirus researchers following false leads (14 April 2020). Nature Index.
• An audience with: John-Arne Røttingen (14 April 2020). Nature Reviews Drug Discovery.

Over 180 clinical trials of proposed COVID-19 drugs are already recruiting patients, and another 150 are registered to start recruiting patients soon. But many of these trials are small and not designed to identify the best treatment strategies for the COVID-19 pandemic.
– John-Arne Røttingen

• Despite COVID-19, Patients Are Interested In New Trials (14 April 2020). Clinical Leader.
• Pfizer’s digital chief: Technology can speed the race to a COVID-19 vaccine (14 April 2020). Fast Company.
• Tests mit Unsicherheiten (14 April 2020). Süddeutsche Zeitung.
• How To Measure COVID-19’s Impact On Clinical Trials In A Given Country (14 April 2020). Clinical Leader.

13 April 2020

• Hurry, Don’t Rush (13 April 2020). Medium.
• COVID-19 Clinical evidence downtime: How to make use of it! (13 April 2020). Medical Devices Clinical.
• Read the New Publications and News for April 13. National Academies Press.
• Cell therapy trials for COVID-19 accelerate & some early reports (13 April 2020). The Niche, Knoepfler Lab Stem Cell Blog.
• Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. Published online April 13, 2020.
• Journalists are recognizing they’re writing a rough draft of history – and can’t say definitively ‘that’s the way it is’ (13 April 2020). The Conversation.

11 April 2020

• False Negatives Raise Doctors’ Doubts About Coronavirus Tests (11 April 2020). Bloomberg.
• New Normal? Takeaways from A Virtual Regulatory Inspection During COVID-19 (n.d.). DIA.
• China clamping down on coronavirus research, deleted pages suggest (11 April 2020). The Guardian.

10 April 2020

• EMA Stands up Task Force to Oversee Regulatory Response to COVID-19 (10 April 2020). Regulatory Focus.
• Covid-19 : Guidance on more regulatory flexibility for medicines (10 April 2020). European Commission.
• ‘Covidisation’ of academic research: opportunities and risks (10 April 2020). Madhukar Pai, via Nature Microbiology Community.

The ongoing COVID-19 pandemic has inspired a flood of research activities, special funding opportunities, and potential career paths. But this ‘Covidisation’ can come at the risk of undermining other areas of research and scholarship.
– Madhukar Pai

• The Real Question on the Hydroxychloroquine Mystery: Why are Doctors Prescribing It? (10 April 2020). Bioethics.net.
• Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19 (10 April 2020). FDA.
• FDA Grants First EUA for Blood Purification Device for COVID-19 Patients (10 April 2020). Regulatory Focus.
• The Need for Virtual Trials: A Site s Perspective (10 April 2020). Applied Clinical Trials.
• Are Clinical Research Sites the Next Victim of COVID-19? (10 April 2020). Matt Maxwell, via LinkedIn.
• More Coronavirus Vaccines and Treatments Move Toward Human Trials (10 April 2020). PharmaVoice.com
• Searching for an effective Covid-19 treatment: promise and peril (10 April 2020). STAT.
• Doctors ‘keep an open mind’ about unproven coronavirus drug, but worry it could do more harm than good (10 April 2020). STAT.
• Hydroxychloroquine And Azithromycin For COVID-19: Benefits TBD, Risks Clear (10 April 2020). Forbes.

9 April 2020

• EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines (9 April 2020). EMA.
• Global regulators stress need for robust evidence on COVID-19 treatments (9 April 2020). EMA.
• Regulators Urge RCTs With Control Arms for COVID-19 Drug Trials (9 April 2020). Regulatory Focus.
• Shut-in scientists are spending more time on research papers (9 April 2020). Nature Index.
• “Human challenge trials,” where healthy volunteers would be exposed to Covid-19, explained (9 April 2020). Vox.
• Trials of anti-tumour necrosis factor therapy for COVID-19 are urgently needed (9 April 2020). The Lancet.
• The Viral ‘Study’ About Runners Spreading Coronavirus Is Not Actually a Study (9 April 2020). Vice.
• Regulators Urge RCTs With Control Arms for COVID-19 Drug Trials (9 April 2020). Regulatory Focus.
• How soon can we respond to COVID-19? (n.d.). EuroBio.
• Is Hydroxychloroquine Making Covid-19 Clinical Trials Harder? (9 April 2020). Undark.
• Is it Time to Hit the Clinical Trial ‘Reset’ Button? (9 April 2020). ACRP.
• Applied Clinical Trials Vol. 29, No 4, April 2020.
• How does COVID-19 kill? Uncertainty is hampering doctors’ ability to choose treatments (9 April 2020). Nature.

8 April 2020

• New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (8 April 2020). Medicaldeviceslegal.
• Possible causes for decreased susceptibility of children to coronavirus (8 April 2020). Pediatric Research.
• Global clinical trials take a major hit from pandemic, with endocrine targeted tests worst hit (8 April 2020). Fierce Biotech.
• COVID-19 Vaccine and Antiviral Drug Development (8 April 2020). Faculty of Pharmaceutical Medicine.
• Survey Shows One Third of Clinical Trial Study Sites Fear Total Closure; 77% Indicate at Least Some Ongoing Research Trials Have Been Impacted Due to COVID-19 (8 April 2020). ACRP.
• Did Gilead just lower the bar on crucial remdesivir trials for Covid-19? Switching endpoints, amping up trial size stir analysts’ fears — and hopes (8 April 2020). Endpoints News.

7 April 2020

• Global regulators discuss observational studies of real world data for COVID-19 medicines (7 April 2020). EMA.
• SARS-CoV-2 Infects T Lymphocytes Through Its Spike Protein-Mediated Membrane Fusion (7 April 2020). Cellular & Molecular Immunology.
• Has COVID-19 Permanently Reshaped the Clinical Trial Landscape? (7 April 2020). ACRP.
• Is the Pandemic a Time for Inflection or Reflection? (7 April 2020). Applied Clinical Trials.
• How the coronavirus will transform science (7 April 2020). C&EN.
• Pandemie: gevolgen voor wetenschappelijk onderzoek (7 April 2020). NTvG.

6 April 2020

• ICMRA meeting: COVID-19 Real-World Evidence and Observational studies (6 April 2020). ICMRA.
• Safely Conducting Essential Research in the Face of COVID-19 (6 April 2020). Bioethics.com
• Medical journal fast-tracks free publication of Covid-19 research (6 April 2020). Research Professional News.
• COVID-19/SARS-CoV-2 Pandemic (6 April 2020). Faculty of Pharmaceutical Medicine blog.
• Critical Illness in Patients With COVID-19: Mounting an Effective Clinical and Research Response. JAMA. Published online April 06, 2020.
• The Quest for a Pandemic Pill (6 April 2020). The New Yorker.
• WHO director-general endorses a voluntary intellectual property pool to develop Covid-19 products(6 April 2020). STAT.

5 April 2020

• Interview with Sean Morrison on cellular therapies for COVID-19 (5 April 2020). The Niche, Knoepfler Lab Stem Cell Blog.
• SARS-CoV-2 and SARS-CoV differ in their cell tropism and drug sensitivity profiles – preprint – (5 April 2020). bioRxiv 2020.04.03.024257.
• Scripps Research Discovers New COVID-19 Antibody Known as CR3022 (5 April 2020). TrialSite News.

4 April 2020

• The unbearable lack of accessible Covid-19 imaging data (4 April 2020). Medium.
• A German Exception? Why the Country’s Coronavirus Death Rate Is Low (4 April 2020). The New York Times.

3 April 2020

• International regulators discuss available knowledge supporting COVID-19 medicine development (3 April 2020). EMA.
• Infect Volunteers to Speed a Coronavirus Vaccine? (3 April 2020). Science 368(6486):16.
• Coronavirus: Medical chiefs call for patients to be enrolled in clinical trials (3 April 2020). Sky news.
• Safely conducting essential research in the face of COVID-19 (3 April 2020). Nature.
• The outbreak that invented intensive care (3 April 2020). Nature.

2 April 2020

• No ‘Magic Pill’: The Fight Over Unproven Drugs for Coronavirus (2 April 2020). Politico.
• Global coalition to accelerate COVID-19 clinical research in resource-limited settings (2 April 2020). The Lancet.
• Viewpoint: It’s time to coordinate the global COVID-19 research effort (2 April 2020). Science Business.
• Camostat bald in klinischen Studien gegen SARS-CoV-2 (2 April 2020). Deutsche Apotheker Zeitung.
• Coronacrisis: een les in risicomanagement (2 april 2020). Quality Business Support.

1 April 2020

• Global regulatory workshop on COVID-19 vaccine development (1 April 2020). PMDA.
• Remote Monitoring, Protocol Amendments Spike With COVID-19 Spread (1 April 2020). CenterWatch.
• FDA Works Around the Clock, Provides More Detailed Guidance on the Conduct of Clinical Trials Amidst the COVID-19 Pandemic (1 May 2020). FDA Law Blog.
• Microneedle Array Delivered Recombinant Coronavirus Vaccines: Immunogenicity and Rapid Translational Development (1 April 2020). EBioMedicine.
• Clinical Trials During COVID-19: Updates From FDA, MHRA and TGA (1 April 2020). Regulatory Focus.
• COVID-19 toont wetenschap en samenleving het belang van open science (1 April 2020). Science Guide.
• FDA Relaxes Clinical Trial Rules for Covid-19 Emergencies (1) (18 March 2020).
• UCSF’s QBI Coronavirus Research Group Identify 69 COVID-19 Potential Drug Candidates based on Protein-based Research (1 April 2020). TrialSite News.
• Strong caveats are lacking as news stories trumpet preliminary COVID-19 research (1 April 2020). HealthNewsReview.org.
• FDA aims to accelerate COVID-19 therapies with new programme (1 April 2020). Pharmafile.
• Sheep and bacteria are helping in the fight against coronavirus – here’s how (1 April 2020). The Conversation.
• Is Remote Clinical Trial Monitoring the New Norm? (1 April 2020). IMARC Research.
• The twenty-two regulatory pathways the FDA is likely to leverage to get new COVID-19 therapies to patients (n.d.). AgencyIQ.
• De medisch professionele standaard in tijden van het coronavirus (1 April 2020). Van Benthem & Keulen.

31 March 2020

• FDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic (31 March 2020). LexBlog.
• Update on treatments and vaccines against COVID-19 under development (31 March 2020). EMA.
• Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure (31 March 2020). The Journal of Infectious Diseases, jiaa152.
• ‘Panic Prescribing’ Untested Coronavirus Treatments: A Danger to Patients Today and Tomorrow (31 March 2020). Health Affairs Blog.
• COVID-19: wat moeder overdraagt op baby (31 March 2020). NTvG.
• COVID-19 Impact on European Trials (31 March 2020). Avania.
• Erasmus MC start met toedienen antistoffen (31 March 2020). Skipr.
• White House pressures FDA on unproven Japanese drug (31 March 2020). POLITICO.
• We shouldn’t rush to use an unproven malaria drug to treat the coronavirus (31 March 2020). STAT.

30 March 2020

• Appendix FAQ Added by FDA to COVID-19 Clinical Trial Guidance (30 March 2020). Clinical Pathways.
• A Rush to Judgment? Rapid Reporting and Dissemination of Results and Its Consequences Regarding the Use of Hydroxychloroquine for COVID-19 (30 March 2020). Annals of Internal Medicine.
• Publishing During the COVID-19 Epidemic: Prompt Conclusions or Quality Studies? (30 March 2020). Johns Hopkins Berman Institute of Bioethics.
• Cull, release or bring them home: Coronavirus crisis forces hard decisions for labs with animals (30 March 2020). Nature.
• Optimizing the Trade-off Between Learning and Doing in a Pandemic. JAMA. Published online March 30, 2020.
• Debate flares over using AI to detect Covid-19 in lung scans (30 March 2020). STAT.
• Biobanks in times of a pandemic like Covid-19 (30 March 2020). Erik Steinfelder, via LinkedIn.
• Covid-19 Hastens Embrace Of Virtual Trials (30 March 2020). Clinical Leader.

29 March 2020

• WHO SOLIDARITY Trial Enrolls First Patient in Norway: The World Requests more Transparency (29 March 2020). TrialsSite News.
• Silicon Valley, Follow, Don’t Lead. Jules Polonetsky, via LinkedIn.

28 March 2020

• The race to develop coronavirus treatments pushes the ethics of clinical trials (28 March 2020). Quartz.
• Plagiarism in Plaguetime (28 March 2020). JURIST Commentary.
• Federale regering en Belgische biofarma-industrie versnellen de inspanningen in de strijd tegen COVID-19 (28 March 2020). Pharma.be
• The Science of This Pandemic Is Moving at Dangerous Speeds (28 March 2020). Wired.

27 March 2020

• Valse hoop? (27 March 2020). NTvG.
• Known Drugs Being Tried Against the Coronavirus: Runner-Up Candidates (27 March 2020). Science Translational Medicine.
• Pivoting health research to take on COVID-19 – What one team learned (27 March 2020). World Economic Forum.
• COVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions (27 March 2020). Parexel.
• How sick will the coronavirus make you? The answer may be in your genes (27 March 2020). Science.
• Transparency & Other Takeaways from COVID-19 Clinical Trials (27 March 2020). TrialScope.
• Digital technology and COVID-19 (27 March 2020). Nature.
• Guidance from the EU EMA and UK MHRA on clinical trials during the COVID-19 Pandemic (27 March 2020). BioSlice Blog, Arnold & Porter.
• COVID-19 needs a Manhattan Project (27 March 2020). Science.

26 March 2020

• Using European supercomputing to treat the coronavirus (26 March 2020). European Commission.
• To Help Develop the Safest, Most Effective Coronavirus Tests, Treatments, and Vaccine, Ensure Public Access to Clinical Research Data (26 March 2020). Health Affairs Blog.
• Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic (26 March 2020). CMAJ.
• As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes? (26 March 2020). The Niche, Knoepfler Lab Stem Cell Blog.
• How Monoclonal Antibodies Might Prove Useful Against The Coronavirus (26 March 2020). NPR.
• Responding to COVID‐19: How to Navigate a Public Health Emergency Legally and Ethically (26 March 2020). The Hastings Center Report.
• ‘Drug development is a long, long process’: pharma CEO in Italy sounds a note of caution on Covid-19 (26 March 2020). STAT.
• ‘We’re racing against the clock’: Researchers test wearables as an early warning system for Covid-19 (26 March 2020). STAT.
• Science-ing from home (26 March 2020). Nature.
• What we’ve learned about the coronavirus — and what we still need to know (26 March 2020). STAT.
• Latest Guidance of the EMA and European and UK National Authorities on Crisis Management of Clinical Trials and Medicine Supplies During the COVID-19 Pandemic (26 March 2020). Arnold & Porter.
• COVID19 Expected to Impact Clinical Trials and Slow Down Drug Development (26 March 2020). ADC Review.
• Wetenschappers in verzet tegen lockdown: ‘We moeten de paniek bezweren’ (26 March 2020). Het Parool.
• What it’s like to go into the lab at a biopharma company during the coronavirus pandemic (26 March 2020). STAT.

25 March 2020

• Join the AI-ROBOTICS vs COVID-19 initiative of the European AI Alliance (25 March 2020). European Commission.
• Gezien bij Op1: Paul Elbers over de inzet van AI tegen COVID-19 (25 March 2020). Vincent Bontrop (website/blog).
• COVID-19: faecal–oral transmission? (25 March 2020). Nature Reviews Gastroenterology & Hepatology.
• Coronavirus shuts down trials of drugs for multiple other diseases (25 March 2020). Nature.
• Geneesmiddelen bij COVID-19 (25 March 2020). NTvG.
• Optimizing COVID‐19 candidate therapeutics: Thinking Without Borders (25 March 2020). Clinical and Translational Science.
• Elsevier: Infographic: global research trends in infectious disease (25 March 2020).
• Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. Published online March 25, 2020.
• Covid-19 roundup: Bristol Myers suspends clinical trials, grounds field team; Vir ushers antibody candidates to human testing (25 March 2020). Endpoints News.
• COVID-19 Vaccine Test Lab Hit by Maze Ransomware (25 March 2020). LexBlog.
• Commission working on proposal to postpone MDR date of application for one year (25 March 2020). Medicaldeviceslegal.

24 March 2020

• Global regulators map out data requirements for phase 1 COVID-19 vaccine trials (24 March 2020). ICMRA.
• Global regulators map out data requirements for phase 1 COVID-19 vaccine trials (24 March 2020). EMA.
• ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies (24 March 2020). Regulatory Focus.
• An Experimental Coronavirus Vaccine is Already Being Tested in People (24 March 2020). OneZero.
• Coronavirus te lijf met big data (24 March 2020). MUMC+
• Onderzoek met ‘big data’ naar beste behandeling coronavirus (24 March 2020). Skipr.
• Sites Increasingly Worried About Coronavirus-Related Trial Interruptions (24 March 2020). ACRP.
• Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. Published online March 24, 2020.
• Covid-19 raakt biotech hard (24 March 2020). HollandBIO.
• DCRF buigt zich over impact corona op klinisch onderzoek (24 March 2020). Vereniging Innovatieve Geneesmiddelen.

23 March 2020

• FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development (23 March 2020). FDA.
• EMA calls to scale up COVID-19 trials for conclusive data (23 March 2020). Outsourcing Pharma Com.
• Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic. JAMA. Published online March 23, 2020.
• Covid-19: How unprecedented data sharing has led to faster-than-ever outbreak research (23 March 2020). Horizon.
• As Covid-19 spreads, disruptions to clinical trial and drug development accelerate (23 March 2020). STAT.
• Pharma boss: EU will have to focus on long-term medical research ecosystem (23 March 2020). Euractiv.
• EU Guidance on Conduct of Clinical Trials During COVID-19 Pandemic and Specific Advice on Initiation of Clinical Trials for Treatments of COVID-19 (23 March 2020). Van Bael & Bellis.
• UK launches whole genome sequence alliance to map spread of coronavirus (23 March 2020). Medical Research Council.
• Academic Library Response to COVID-19: Real-Time Data Gathering and Dissemination (23 March 2020). The Scholary Kitchen.
• Covid-19 is reshaping the world of bioscience publishing (23 March 2020). STAT.

22 March 2020

• Coronavirus: How Artificial Intelligence, Data Science And Technology Is Used To Fight The Pandemic (22 March 2020). Bernard Marr, via LinkedIn.
• WHO launches global megatrial of the four most promising coronavirus treatments (22 March 2020). Science.

21 March 2020

• Hunt for coronavirus cure is making science more open (21 March 2020). University World News.
• Cardialysis: Update via LinkedIn (21 March 2020).

20 March 2020

• Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (20 March 2020). EMA.
• EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic (20 March 2020). Regulatory Focus.
• NIH shifts non-mission-critical laboratory operations to minimal maintenance phase (20 March 2020). NIH.
• CLAIRE: Open Letter Leveraging artificial intelligence to help manage the Covid-19 crisis.
• The coronavirus is imperiling drug studies. A virtual study of the Apple Watch could be positioned to thrive (20 March 2020). STAT.

19 March 2020

• FDA Provides Welcome Guidance for Clinical Trials During COVID-19 (19 March 2020). BioSpace.
• FDA Releases Guidance on Clinical Trial Conduct During COVID-19 Pandemic (19 March 2020). Covington.
• Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments (19 March 2020). EMA.
• Coronavirus lockdown: What I learnt when I shut my cancer lab in 48 hours (19 March 2020). Nature.
• 8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them (19 March 2020). Med Device Online.
• Call To Pool Research Resources into Large Trials to Generate Evidence On COVID-19 Treatments (19 March 2020). Applied Clinical Trials.
• Biotech in the time of the coronavirus: Disruptions continue, but there’s some good news, too (19 March 2020). STAT.
• Clinical Trial Practitioners Grapple with Challenges from Pandemic (19 March 2020). ACRP.
• NVIC verwacht komende week grote toename ic-opnames door corona (19 March 2020. Medisch Contact.
• 4 principles journals can embrace to aid reproducibility of research (19 March 2020). Elsevier.
• UAntwerpen (Flanders) leads European coronavirus taskforce (19 March 2020). Flanders.bio.

18 March 2020

• Conducting a Clinical Trial Amidst the COVID-19 Pandemic? FDA Issues Guidance to Help Sponsors with Decision-making to Overcome Challenges (18 March 2020). FDA Law Blog.
• FDA Urges Clinical Researchers to go Virtual in Response to COVID-19 Pandemic (18 Marcho 2020). Fierce Biotech.
• First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development (18 March 2020). EMA.
• How to Salvage Clinical Trials During an Epidemic (18 March 2020). ACRP.
• Desk-based Health Authority Inspections: A Risk-based Approach to Compliance (18 March 2020). Parexel.
• WHO to launch multinational trial to jumpstart search for coronavirus drugs (18 March 2020). STAT.
• FDA urges clinical researchers to go virtual in response to COVID-19 pandemic (18 March 2020). FierceBiotech.
• Coronavirus will have a ‘big impact’ on one-third of U.S. clinical trial sites, survey finds (18 March 2020). STAT.
• Clinical trial sites anticipate disruption due to Covid-19; FDA issues guidance for trials amid pandemic (18 March 2020). MedCity News.
• FDA urges virtual patient visits as coronavirus disrupts clinical trials – Reuters (18 March 2020). Reuters.
• Coronavirus led one biotech to pause a key trial, as more begin to follow (18 March 2020). BioPharma Dive.
• As Covid-19 R&D goes into overdrive, nuts-and-bolts biopharma research is hitting the skids. How bad is it? (18 March 2020). Endpoints News.
• De farmaceutische sector en de strijd tegen het COVID-19 virus (18 March 2020). Pharma.be.
• Sponsors Offer Tips to Help Maintain Trials During Coronavirus Crisis (18 March 2020). ACRP.

17 March 2020

• Syneos Health: Our Connected Community: Syneos Health Response to COVID-19 (17 March 2020).
• COVID-19 Briefing: Notes from Covington & Burling March 13 Teleconference “COVID-19: Evolving Considerations for the Life Sciences Industry” (17 March 2020). Govzilla.
• Navigating Clinical Trials in the Coronavirus Era (March 2020). Science37.
• Report sees ‘untold’ coronavirus impact on clinical research (17 March 2020). Outsourcing Pharma com.
• Effect COVID-19 op klinische studies (17 March 2020). Dutch Oncology Research Platform.
• COVID-19: Corona and Clinical Trials (17 March 2020). Trial & Eric.
• ACRO Calls for Increased Centralized Monitoring, New Guidelines to Assist Trial Conduct Amidst Corona Disruption (17 March 2020). ACRP.
• Novel coronavirus (COVID-19) (17 March 2020). IFPMA.
• A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data (17 March 2020). STAT.

16 March 2020

• Editorial Concern—Possible Reporting of the Same Patients With COVID-19 in Different Reports. JAMA. Published online March 16, 2020.

The editors have become aware that some of the patients described in some of these manuscripts, sometimes with overlapping authorship, have been reported in more than 1 submission. This inclusion of the same patients in more than 1 report has not been clearly indicated in the submitted manuscripts. This is of concern and may represent a lapse in ethical standards of scientific reporting.
– Editorial, JAMA, 16 March 2020, doi:10.1001/jama.2020.3980

• To spur new AI tools to fight coronavirus, tech leaders launch open database of scientific articles (16 March 2020). STAT.
• The global impact of COVID-19 on clinical trials and countermeasure development (16 March 2020). Hogan Lovells.
• Publishers make coronavirus (COVID-19) content freely available and reusable (16 March 2020). Wellcome
• Recruitment platform offered free-of-charge for coronavirus clinical trials (16 March 2020). Outsourcing Pharma com.
• Kennissector gaat op slot door coronacrisis (16 March 2020). ScienceGuide.
• Pfizer schetst ‘Vijf-Punten Plan’ om COVID-19 te bestrijden (16 March 2020). Pfizer.
• COVID-19 Upends Business-as-usual Research and Regulatory Practices (16 March 2020). PharmExecCom.
• Biowetenschappen en Maatschappij Cahier: Help, ik ben besmet! (16 March 2020).

15 March 2020

• Sponsors Delay Trials and Shift Toward Using Remote Procedures (15 March 2020). CenterWatch.

14 March 2020

• Coronavirus pandemic forces some research labs to shut down, with uncertain futures for scientific projects (14 March 2020). STAT.

13 March 2020

• COVID-19: developers of medicines or vaccines to benefit from free scientific advice (13 March 2020). EMA.
• Elsevier gives full access to its content on its COVID-19 Information Center for PubMed Central and other public health databases to accelerate fight against coronavirus (13 March 2020).
• Data Sharing and Open Source Software Help Combat Covid-19 (13 March 2020). Wired.

12 March 2020

• Clinical Trials Feel the Coronavirus Crunch (12 March 2020). Applied Clinical Trials.
• Changes To Research Made In Response To COVID-19 (12 March 2020). Clinical Leader.

10 March 2020

• As Covid-19 Fears Mount, a Face Mask Shortage Imperils Research (10 March 2020). Undark.

6 March 2020

• How It All Started: China’s Early Coronavirus Missteps (6 March 2020). The Wall Street Journal.

19 Februari 2020

• Speed science: The risks of swiftly spreading coronavirus research (19 Februari 2020). Reuters.

3 February 2020

• Quick retraction of a faulty coronavirus paper was a good moment for science (3 February 2020). STAT.

Older

• The Ebola clinical trials: a precedent for research ethics in disasters. Journal of Medical Ethics 2018;44:3-8.
• Ethical Criteria for Human Challenge Studies in Infectious Diseases. Public Health Ethics 2016;9(1):92-103.
• Ebola Vaccine Trials Raise Ethical Issues. Science 2014;346(6207):289-290.
• Evaluating Novel Therapies During the Ebola Epidemic. JAMA 2014;312(13):1299-1300.
• Ethical Considerations of Experimental Interventions in the Ebola Outbreak. Lancet 2014;384:1896-1899.

Overige berichtgeving mbt. AVG, Bescherming persoonsgegevens, Privacy

• EDPB Publishes Guidelines on COVID-19 Related Data Usage (14 May 2020). LexBlog.
• EDPB’s New Guidelines – Clinical Trials in the EU and COVID-19 (1 May 2020). LexBlog.
• Carrying the torch in times of darkness (30 April 2020). European Data Protection Supervisor.
• Using Health Data in Europe During COVID-19 (30 April 2020). LexBlog.
• European Data Protection Board Issues Guidelines on Processing Personal Data for Scientific Research Related to COVID-19 (27 April 2020). LexBlog.
• EDPB Adopts Guidelines on the Processing of Health Data During COVID-19 (22 April 2020). LexBlog.
• Medisch data-onderzoek in het AVG-tijdperk: een zoektocht naar de juiste regels (April 2020). Tijdschrift voor Gezondheidsrecht.
• Open Letter: Contact Tracking and NHSX (21 April 2020). Medium.
• Inderdaad, bescherming van persoonsgegevens gaat over veel meer dan privacy (20 April 2020). Internetrecht door Arnoud Engelfriet.
• COVID-19 Bulletin: Recent Zoom Security Issues Serve as a Cautionary Tale for Businesses in Times of Crisis (and not) (16 April 2020). LexBlog.
• Data crossing borders. Data Sharing and Protection in Times of Coronavirus (15 April 2020). Verfassungsblog.
• How much access to data should be permitted during the COVID-19 pandemic? (14 April 2020). Harvard Law Today.
• Fundamental Rights More Important Than Ever (9 April 2020). VUB.
• Why data protection law is uniquely equipped to let us fight a pandemic with personal data (6 April 2020). pdpEcho.
• EU privacy experts push a decentralized approach to COVID-19 contacts tracing (6 April 2020). Techcrunch.
• The Coronavirus Crisis and EU Adequacy Decisions for Data Transfers (3 April 2020). European Law Blog.
• Volgens mij bestaat “echt geanonimiseerde data” helemaal niet bij locatiedata, maar goed (2 April 2020). Internetrecht door Arnoud Engelfriet.
• The Italian Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency (30 March 2020). LexBlog.
• EDPS Publishes Letter Addressing Coronavirus and Monitoring Location Data (27 March 2020). Privacy & Information Security Law Blog.
• The Corona Effect of Shaping the Future. On Trojan Horses and ‘The New Normal’ (27 March 2020). Marlon Domingus, via LinkedIn.
• Verzameling van metadata door de Europese Commissie – noodzaak in crisistijd? (27 March 2020). Sybren Spoelstra, via LinkedIn.
• Privacy and Pandemics: A Thoughtful Discussion (27 March 2020). Future of Privacy Forum.
• EDPS Letter Monitoring spread of COVID-19 (25 March 2020). European Data Protection Supervisor.
• Data in de strijd tegen corona – hoe zit het met de privacy? (24 March 2020). SOLV.
• UK Information Commissioner Releases COVID-19 Guidance for Controllers and Health and Care Practitioners (23 March 2020). LexBlog.
• Global Privacy Assembly Tracking Data Protection Authority Guidance on COVID-19 (23 March 2020). LexBlog.
• COVID-19, Scientific Research and the GDPR – Some Basic Principles (20 March 2020). Inside Privacy, Covington.
• Ensuring Data Security and Privacy During Coronavirus (19 March 2020). LexBlog.
• EDPB Clarifies Privacy Rules for COVID-19 (17 March 2020). LexBlog.
• COVID-19 Update: Limited Waiver of HIPAA Sanctions and Penalties for Certain Hospitals (17 March 2020). LexBlog.
• HIPAA Privacy Rule Waiver, Other Medical Information Questions During the COVID-19 Pandemic (17 March 2020). LexBlog.
• EDPB Chair Issues Statement on Data Protection and COVID-19 (16 March 2020). LexBlog.
• Coronavirus and Data Protection: Europe’s Data Protection Authorities’ Views (16 March 2020). LexBlog.
• Coronavirus and data protection –Guidance by data protection authorities (Last updated: 16 March 2020). Hogan Lovells.
• COVID-19 Bulletin: Balancing Privacy and Public Health Needs (16 March 2020). LexBlog.
• AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency (13 March 2020). Hogan Lovells.
• Spanish Data Protection Authority: Protect Personal Data Without Hindering Pandemic Response (13 March 2020). LexBlog.
• Coronavirus en het medisch beroepsgeheim (13 March 2020). TeekensKarstens Advocaten.
• Coronavirus en privacy: onze tips voor werkgevers (6 March 2020). TeekensKarstens Advocaten.
• Key COVID-19 Issues for Privacy Professionals (10 March 2020). LexBlog.
• Data Protection Issues Raised by Guidance and Efforts to Prevent the Spread of COVID-19 (9 March 2020). LexBlog.
• Danish Data Authority Issues Guidance on COVID-19 Data Disclosure 9 March 2020). LexBlog.
• Norwegian Supervisory Authority Issues COVID-19 Guidance (10 March 2020). LexBlog.
• Is corona een vrijbrief om privacy te schenden? Privacylab.
• Genomineerd voor een prijs: Hoe we het huisadres van duizenden militairen en inlichtingenmedewerkers vonden in een fitness-app (7 March 2020). De Correspondent.

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