Coronavirus, COVID-19 & Clinical Research: an overview

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This page is no longer being actively updated and information presented on this page may be outdated.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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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.

International Pharmaceutical Federation (FIP)

Nuffield Council on Bioethics

Patient Focused Medicines Development (PFMD)

UNESCO/International Bioethics Committee

Unicef

World Health Organization

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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 Medicines Agency

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

Heads of Medicines Agencies

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Countries

Europe

Netherlands

Belgium

Austria

Bulgaria

Czech Republic

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Norway

Portugal

Romania

Slovakia

Slovenia

Spain

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

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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

Pharma.be

Regulatory Science Network Netherlands

Research Data Alliance

Research Quality Association (RQA)

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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

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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

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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

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

EMBL-EBI

Imaging COVID-19 AI initiative

Indian Institute of Technology Kharagpur

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

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

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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

#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

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Grants, Funding

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Webinars

Past webinars

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Other news

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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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