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The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days.

Identifieur interne : 000196 ( Main/Exploration ); précédent : 000195; suivant : 000197

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days.

Auteurs : Perrine Janiaud [États-Unis, Suisse] ; Cathrine Axfors [États-Unis, Suède] ; Janneke Van'T Hooft [États-Unis, Pays-Bas] ; Ramon Saccilotto [États-Unis] ; Arnav Agarwal [Canada] ; Christian Appenzeller-Herzog [Suisse] ; Despina G. Contopoulos-Ioannidis [États-Unis] ; Valentin Danchev [États-Unis] ; Ulrich Dirnagl [Allemagne] ; Hannah Ewald [Suisse] ; Gerald Gartlehner [Autriche, États-Unis] ; Steven N. Goodman [États-Unis] ; Noah A. Haber [États-Unis] ; Angeliki Diotima Ioannidis [États-Unis] ; John P A. Ioannidis [États-Unis, Allemagne] ; Mark P. Lythgoe [Royaume-Uni] ; Wenyan Ma [Suisse] ; Malcolm Macleod [Royaume-Uni] ; Mario Mali Ki [États-Unis] ; Joerg J. Meerpohl [Allemagne] ; Yan Min [États-Unis] ; David Moher [Canada] ; Blin Nagavci [Allemagne] ; Florian Naudet [France] ; Christiane Pauli-Magnus [Suisse] ; Jack W. O'Sullivan [États-Unis] ; Nico Riedel [Allemagne] ; Jan A. Roth [Suisse] ; Mandy Sauermann [Suisse] ; Stefan Schandelmaier [Suisse, Canada] ; Andreas M. Schmitt [Suisse] ; Benjamin Speich [Suisse, Royaume-Uni] ; Paula R. Williamson [Royaume-Uni] ; Lars G. Hemkens [États-Unis, Suisse, Allemagne]

Source :

RBID : pubmed:33082937

Descripteurs français

English descriptors

Abstract

Background: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic. Methods: Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020. Results: Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited <20% of the targeted sample; 27 between 20-50%; and 30 over 50% (median 14.8% [IQR 2.0-62.0%]). Conclusions: The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.

DOI: 10.12688/f1000research.26707.2
PubMed: 33082937
PubMed Central: PMC7539080


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<name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name>
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<country xml:lang="fr">Suisse</country>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
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<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
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<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford</wicri:regionArea>
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<country xml:lang="fr">Royaume-Uni</country>
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<country xml:lang="fr">Suisse</country>
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<title xml:lang="en">The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days.</title>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
</placeName>
<orgName type="university">Université Stanford</orgName>
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<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
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<name sortKey="Axfors, Cathrine" sort="Axfors, Cathrine" uniqKey="Axfors C" first="Cathrine" last="Axfors">Cathrine Axfors</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<orgName type="university">Université Stanford</orgName>
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<country xml:lang="fr">Suède</country>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Medicine, University of Toronto, Toronto, Ontario</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
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<region type="state">Ontario</region>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University Medical Library, University of Basel, Basel</wicri:regionArea>
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<country xml:lang="fr">États-Unis</country>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford Prevention Research Center, Department of Medicine,, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
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<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Berlin</wicri:regionArea>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>University Medical Library, University of Basel, Basel</wicri:regionArea>
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<nlm:affiliation>Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems</wicri:regionArea>
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<country xml:lang="fr">États-Unis</country>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
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<orgName type="university">Université Stanford</orgName>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford University School of Medicine, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
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<name sortKey="Haber, Noah A" sort="Haber, Noah A" uniqKey="Haber N" first="Noah A" last="Haber">Noah A. Haber</name>
<affiliation wicri:level="4">
<nlm:affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
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<orgName type="university">Université Stanford</orgName>
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<nlm:affiliation>Molecular Toxicology Interdepartmental Program, University of California, Los Angeles, Los Angeles, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Molecular Toxicology Interdepartmental Program, University of California, Los Angeles, Los Angeles, California</wicri:regionArea>
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<region type="state">Californie</region>
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<name sortKey="Ioannidis, John P A" sort="Ioannidis, John P A" uniqKey="Ioannidis J" first="John P A" last="Ioannidis">John P A. Ioannidis</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford Prevention Research Center, Department of Medicine,, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford University School of Medicine, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
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<country xml:lang="fr">États-Unis</country>
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<region type="state">Californie</region>
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<nlm:affiliation>Department of Surgery & Cancer, Imperial College London, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Surgery & Cancer, Imperial College London, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Ma, Wenyan" sort="Ma, Wenyan" uniqKey="Ma W" first="Wenyan" last="Ma">Wenyan Ma</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Macleod, Malcolm" sort="Macleod, Malcolm" uniqKey="Macleod M" first="Malcolm" last="Macleod">Malcolm Macleod</name>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh</wicri:regionArea>
<placeName>
<settlement type="city">Édimbourg</settlement>
<region type="country">Écosse</region>
</placeName>
<orgName type="university">Université d'Édimbourg</orgName>
</affiliation>
</author>
<author>
<name sortKey="Mali Ki, Mario" sort="Mali Ki, Mario" uniqKey="Mali Ki M" first="Mario" last="Mali Ki">Mario Mali Ki</name>
<affiliation wicri:level="4">
<nlm:affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
</placeName>
<orgName type="university">Université Stanford</orgName>
</affiliation>
</author>
<author>
<name sortKey="Meerpohl, Joerg J" sort="Meerpohl, Joerg J" uniqKey="Meerpohl J" first="Joerg J" last="Meerpohl">Joerg J. Meerpohl</name>
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<country xml:lang="fr">Allemagne</country>
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<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Fribourg-en-Brisgau</region>
<settlement type="city">Fribourg-en-Brisgau</settlement>
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</affiliation>
<affiliation wicri:level="3">
<nlm:affiliation>Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Cochrane Germany, Cochrane Germany Foundation, Freiburg</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Fribourg-en-Brisgau</region>
<settlement type="city">Fribourg-en-Brisgau</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Min, Yan" sort="Min, Yan" uniqKey="Min Y" first="Yan" last="Min">Yan Min</name>
<affiliation wicri:level="4">
<nlm:affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
</placeName>
<orgName type="university">Université Stanford</orgName>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Stanford University School of Medicine, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name>
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<country xml:lang="fr">Canada</country>
<wicri:regionArea>Centre for Journalology, Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa</wicri:regionArea>
<placeName>
<settlement type="city">Ottawa</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Nagavci, Blin" sort="Nagavci, Blin" uniqKey="Nagavci B" first="Blin" last="Nagavci">Blin Nagavci</name>
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<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Institute for Evidence in Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Fribourg-en-Brisgau</region>
<settlement type="city">Fribourg-en-Brisgau</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Naudet, Florian" sort="Naudet, Florian" uniqKey="Naudet F" first="Florian" last="Naudet">Florian Naudet</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)],, University of Rennes 1, Rennes</wicri:regionArea>
<placeName>
<region type="region">Région Bretagne</region>
<region type="old region">Région Bretagne</region>
<settlement type="city">Rennes</settlement>
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<author>
<name sortKey="Pauli Magnus, Christiane" sort="Pauli Magnus, Christiane" uniqKey="Pauli Magnus C" first="Christiane" last="Pauli-Magnus">Christiane Pauli-Magnus</name>
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<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="O Sullivan, Jack W" sort="O Sullivan, Jack W" uniqKey="O Sullivan J" first="Jack W" last="O'Sullivan">Jack W. O'Sullivan</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
</placeName>
<orgName type="university">Université Stanford</orgName>
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<nlm:affiliation>Division of Cardiology, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Cardiology, Department of Medicine, Stanford University School of Medicine, Stanford, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Riedel, Nico" sort="Riedel, Nico" uniqKey="Riedel N" first="Nico" last="Riedel">Nico Riedel</name>
<affiliation wicri:level="3">
<nlm:affiliation>QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>QUEST Center for Transforming Biomedical Research, Berlin Institute of Health, Berlin</wicri:regionArea>
<placeName>
<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
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<name sortKey="Roth, Jan A" sort="Roth, Jan A" uniqKey="Roth J" first="Jan A" last="Roth">Jan A. Roth</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Sauermann, Mandy" sort="Sauermann, Mandy" uniqKey="Sauermann M" first="Mandy" last="Sauermann">Mandy Sauermann</name>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Schandelmaier, Stefan" sort="Schandelmaier, Stefan" uniqKey="Schandelmaier S" first="Stefan" last="Schandelmaier">Stefan Schandelmaier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario</wicri:regionArea>
<orgName type="university">Université McMaster</orgName>
<placeName>
<settlement type="city">Hamilton (Ontario)</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Schmitt, Andreas M" sort="Schmitt, Andreas M" uniqKey="Schmitt A" first="Andreas M" last="Schmitt">Andreas M. Schmitt</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1">
<nlm:affiliation>Deparment of Medical Oncology, University Hospital Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Deparment of Medical Oncology, University Hospital Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Speich, Benjamin" sort="Speich, Benjamin" uniqKey="Speich B" first="Benjamin" last="Speich">Benjamin Speich</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4">
<nlm:affiliation>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford</wicri:regionArea>
<placeName>
<settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author>
<name sortKey="Williamson, Paula R" sort="Williamson, Paula R" uniqKey="Williamson P" first="Paula R" last="Williamson">Paula R. Williamson</name>
<affiliation wicri:level="1">
<nlm:affiliation>MRC/NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>MRC/NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool</wicri:regionArea>
<wicri:noRegion>Liverpool</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Hemkens, Lars G" sort="Hemkens, Lars G" uniqKey="Hemkens L" first="Lars G" last="Hemkens">Lars G. Hemkens</name>
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<nlm:affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California</wicri:regionArea>
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<region type="state">Californie</region>
<settlement type="city">Stanford (Californie)</settlement>
</placeName>
<orgName type="university">Université Stanford</orgName>
</affiliation>
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<nlm:affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Research, University of Basel, Basel</wicri:regionArea>
<wicri:noRegion>Basel</wicri:noRegion>
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<nlm:affiliation>Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany.</nlm:affiliation>
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<wicri:regionArea>Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin</wicri:regionArea>
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<settlement type="city">Berlin</settlement>
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<term>Betacoronavirus (MeSH)</term>
<term>Biomedical Research (trends)</term>
<term>COVID-19 (MeSH)</term>
<term>China (MeSH)</term>
<term>Clinical Trials as Topic (MeSH)</term>
<term>Coronavirus Infections (prevention & control)</term>
<term>Coronavirus Infections (therapy)</term>
<term>Humans (MeSH)</term>
<term>Pandemics (prevention & control)</term>
<term>Pneumonia, Viral (prevention & control)</term>
<term>Pneumonia, Viral (therapy)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>United States (MeSH)</term>
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<term>Betacoronavirus (MeSH)</term>
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<div type="abstract" xml:lang="en">
<b>Background</b>
: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic.
<b>Methods:</b>
Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020.
<b>Results:</b>
Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited <20% of the targeted sample; 27 between 20-50%; and 30 over 50% (median 14.8% [IQR 2.0-62.0%]).
<b>Conclusions:</b>
The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" VersionID="2" VersionDate="2020/10/26" IndexingMethod="Curated" Owner="NLM">
<PMID Version="2">33082937</PMID>
<DateCompleted>
<Year>2020</Year>
<Month>11</Month>
<Day>06</Day>
</DateCompleted>
<DateRevised>
<Year>2021</Year>
<Month>01</Month>
<Day>10</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection">
<Journal>
<ISSN IssnType="Electronic">2046-1402</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>9</Volume>
<PubDate>
<MedlineDate>2020</MedlineDate>
</PubDate>
</JournalIssue>
<Title>F1000Research</Title>
<ISOAbbreviation>F1000Res</ISOAbbreviation>
</Journal>
<ArticleTitle>The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days.</ArticleTitle>
<Pagination>
<MedlinePgn>1193</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.12688/f1000research.26707.2</ELocationID>
<Abstract>
<AbstractText>
<b>Background</b>
: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic.
<b>Methods:</b>
Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020.
<b>Results:</b>
Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited <20% of the targeted sample; 27 between 20-50%; and 30 over 50% (median 14.8% [IQR 2.0-62.0%]).
<b>Conclusions:</b>
The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.</AbstractText>
<CopyrightInformation>Copyright: © 2020 Janiaud P et al.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Janiaud</LastName>
<ForeName>Perrine</ForeName>
<Initials>P</Initials>
<Identifier Source="ORCID">https://orcid.org/0000-0001-7684-8014</Identifier>
<AffiliationInfo>
<Affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Department of Clinical Research, University of Basel, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Axfors</LastName>
<ForeName>Cathrine</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Department for Women's and Children's Health, Uppsala University, Uppsala, Sweden.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Van't Hooft</LastName>
<ForeName>Janneke</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Amsterdam University Medical Center, Amsterdam University, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Saccilotto</LastName>
<ForeName>Ramon</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Meta-Research Innovation Center at Stanford (METRICS), Stanford University,, Stanford, California, USA.</Affiliation>
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