Coronavirus, COVID-19 & Clinical Research: an overview

Last updated: 5 July 2020, 1:12 PM (CET)
The overview below originates from the ‘Nieuwsbrief voor Goede Onderzoekspraktijken (#110, 15 March 2020)‘ (translation: Newsletter for Good Research Practices) and supplemented by information that has since become available on the internet.

As developments regarding COVID quickly follow, the content of this page may be outdated tomorrow. As soon as new information is available it will be added to this page. But please always check the original source for actual information.

If there are important links missing, or if you have found any broken links, please contact me by using the contact form.

In the case of important developments for the Netherlands, I will share them with my subscribers via a separate notification message. More information, click here (in Dutch).

Do you have any additions or suggestions? Send an email to covid@bontrop.com

Onderstaand overzicht is overgenomen uit de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘nr. 110 van 15 maart 2020 en aangevuld met informatie die ondertussen beschikbaar is gekomen op internet. Het betreft uiteraard een tijdsopname en informatie kan morgen alweer achterhaald zijn. Zodra er nieuwe informatie beschikbaar is zal deze worden toegevoegd aan deze pagina.

Als u belangrijke informatie en/of verwijzing mist dan kunt u die met mij delen via het contact formulier. Mochten er voor Nederland belangrijke ontwikkelingen zijn dan zal ik dat met mijn abonnees delen via een apart notificatie bericht. Meer informatie, klik hier.

Heeft u een aanvulling of suggesties? Stuur een e-mail naar covid@bontrop.com

Ook interessant: ‘COVID-19: Research professionals over de gevolgen, implicaties en kansen‘, ‘Gezien bij Op1: Paul Elbers over de inzet van AI tegen COVID-19‘ en ‘Voor Nederland bruikbare guidance voor mensgebonden onderzoek in verband met COVID-19‘.

Content

Quick links

 

Suggestions, missing links or broken links?

Please use the contact form or covid@bontrop.com to contact me.


Global

Committee on Publication Ethics  (COPE)

Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)

International Coalition of Medicines Regulatory Authorities (ICMRA)

Internation Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

International Pharmaceutical Federation (FIP)

Medical Dictionary for Regulatory Activities (MedDRA)

Nuffield Council on Bioethics

Pan American Health Organization and World Health Organization (PAHO)

Patient Focused Medicines Development (PFMD)

TransCelerate

UNESCO/International Bioethics Committee

Unicef

Wellcome

World Health Organization

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


Europe/European Union

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

CEN CENELEC

Council of Europe

European Centre for Disease Prevention and Control

European Clinical Research Infrastructrure Network (ECRIN)

European Commission

European Confederation of Pharmaceutical Entrepreneurs (AISBL)

European Council

European CRO Federation (EUCROF)

European Data Protection Board

European Data Protection Supervisor

European Federation of Academies of Sciences and Humanities – All European Academies (ALLEAN

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Medicines Agency

European Network for Health Technology Assessment (EUnetHTA)

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

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

European Network of Research Integrity Offices (ENRIO)

European Organisation for Research and Treatment of Cancer (EORTC)

European Patients’ Academy on Therapeutic Innovation (EUPATI)

European Strategy Forum on Research Infrastructures (ESFRI)

Heads of Medicines Agencies

Medical Devices Coordination Group (MDCG)

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


Countries

Europe

Netherlands

Dit servicedocument biedt instellingen handreikingen waarmee zij in de praktijk invulling kunnen geven aan de maatregelen voor het hoger onderwijs om de verspreiding van het coronavirus tegen te gaan. – Ministerie OCW

Belgium

Austria

Bulgaria

Czech Republic

Croatia

Cypres

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Malta

Norway

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

Switzerland

Ukraine

United Kingdom

Africa

Kenia

South Africa

America

Brazil

Canada

Colombia

Peru

United States

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

Asia

Japan

Singapore

Australia

Australia

Middle East

Jordan

Turkey

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


Organizations, Professional Associations, Research networks

Association of Clinical Research Organizations (ACRO)

Associatie van Contract Research Organisaties in Nederland (ACRON)

Association of Clinical Research Professionals (ACRP)

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Trials Transformation Initiative

Coalition for Epidemic Preparedness Innovation (CEPI)

Cochrane

Combacte

Drug Information Association

Dutch Clinical Research Foundation

European Network of Research Ethics and Research Integrity (ENERI)

Global Infectious Diseases and Epidemiology Network (GIDEON)

Health-RI

International Association of Privacy Professionals (IAPP)

Life Science Research Infrastructures

Medical associations and organizations

Nederlandse Federatie van Universitair Medische Centra (NFU)

Pharma.be

Regulatory Science Network Netherlands

Research Data Alliance

Research Quality Association (RQA)

Society for Clinical Data Management (SCDM)

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


Clinical trials

BMC Trials

Centre for Evidence-Based Medicine (CEBM)

Clinical trial data sharing

Clinical trial registries, Research registries

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

Clinical Research Organisations

Clinical research resources

Good Research Practices

Investigational Medical Products, Pharmaceutics

Outcomes

Society for Clinical Research Sites (SCRS)

Vaccine development

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


Biobanking, Patient Registries

BBMRI

Biosafety

Biosample Hub

COPP studie

COVIDPredict

Guidance biobanking and biospecimines

International Society for Biological and Environmental Repositories (ISBER).

Lifelines

UKCRC Tissue Directory and Coordination Centre

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


Patient Registries, Artificial Intelligence, Data management, Datasets

Artificial Intelligence/Kunstmatige Intelligentie

ASH RC COVID-19 Registry for Hematologic Malignancy

AWS Cloud

CAPACITY registry

Covid19 Challenge.eu

COVID-evidence

COPP Studie

Data Archiving and Networked Services (DANS)

Data management

Data Networks and research

Data sharing

… 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

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

EMBL-EBI

Imaging COVID-19 AI initiative

Indian Institute of Technology Kharagpur

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

Luscii

Nationale Intensive Care Evaluatie (NICE)

Observational Health Data Sciences (OHDSI)

Publications Office of the European Union

Secure Collective Covid-19 Research

Society of Critical Care Medicine (SCCM) – VIRUS

Trackers & maps

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


Resources

Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)

Animal research

API (application programming interface)

Center for Open Science

Courses, Educative, Training

Collaboration

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

#connectuniversitiesNL

#CoronavirusSyllabys (on Twitter)

Covid-19, Coronavirus disease 2019

Diagnostics, Genomics, Viral strains

Ethiek

Good Manufacturing Practice

Hacking Health

High Ambiguity Driven protein-protein DOCKing (HADDOCK)

Infectious Diseases Data Observatory

Internet Book of Critical Care (IBCC)

Medical Devices

OpenAIRE

Open Knowledge Foundation

RADAR-CNS

Research output

Resources

Social Sciences and Humanities, Expertise

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

Updates

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


Grants, Funding

Crowdhelix Network

EuropeBio

European Commission, H2020

Europen Coorperation in Science & Technology – COST

European Research Council (ERC)

Funding opportunities

Funding

Funding support

Health Holland

Innovative Medicines Initiative

KCE Trials

League of European Research Universities

Marie Skłodowska-Curie

Medical Research Council

National Health and Medical Research Council (NHMRC)

National Institutes of Health (NIH)

NWO

UK Research and Innovation (UKRI)

Wellcome

ZonMw

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


Webinars

Past webinars

  • The Global Health Network: The COVID-19 Open Workshop for Research Implmentation, Session 1 (13 March 2020)
    View recording/summary
  • The Global Health Network: The COVID-19 Open Workshop for Research Implmentation, Session 2 (13 March 2020)
    View recording/summary
  • The Global Health Network: Como estamos respondendo ao desafio de pesquisa em COVID-19? (31 March 2020)
    View recording/summary
  • RSNA: Radiology Preparedness for COVID-19: Radiology Scientific Expert Review Panel (18 March 2020).
    View recording
  • Castor EDC: Webinar: Research Continuity During COVID-19 (27 March 2020).
    View recording
  • Clinical Trials Transformation Initiative: Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic (31 March 2020).
    View recording
    Download slides/notes
  • Clinipace – Business Continuity: GCP Compliant Clinical Trials (31 March 2020).
    Download slides/notes
  • RQA Webinar: COVID-19 ‘GxP Insights on Building Resilience and Agility’ (31 March 2020).
    View recording
  • GCP Central: Live Webinar ‘Clinical trials during corona – a risk-based approach in the interest of patients and data’ (2 April 2020).
    View recording
  • Imaging COVID-19 AI project: Using AI with CT images to diagnose COVID-19 – AI Suisse (3 April 2020).
    View recording
  • Nuffield Council of Bioethics: Ethics in the research response to COVID-19 (3 April 2020)
    View recording
  • Syneos Health: Implementing Remote Clinical Trial Monitoring to Ensure Continuity of Trials and Data Preservation – While Keeping Patients Safe (3 April 2020).
    View recording
  • ISBER: Understanding COVID-19 Webinar (7 April 2020).
    View recording
  • Pharmaphorum & ERT: webinar Vaccines trials in the era of COVID-19 – balancing study speed, accuracy and patient experience (8 April 2020)
    View recording
  • EC, HMA & EMA: Webinaron the Guidance on the management of clinical trials during the COVID-19 pandemic (15 May 2020)
    View recording

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


Other news

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

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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

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

13 April 2020

11 April 2020

10 April 2020

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

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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

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