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

Janiaud, Perrine and Axfors, Cathrine and Van't Hooft, Janneke and Saccilotto, Ramon and Agarwal, Arnav and Appenzeller-Herzog, Christian and Contopoulos-Ioannidis, Despina G. and Danchev, Valentin and Dirnagl, Ulrich and Ewald, Hannah and Gartlehner, Gerald and Goodman, Steven N. and Haber, Noah A. and Ioannidis, Angeliki Diotima and Ioannidis, John P. A. and Lythgoe, Mark P. and Ma, Wenyan and Macleod, Malcolm and Malički, Mario and Meerpohl, Joerg J. and Min, Yan and Moher, David and Nagavci, Blin and Naudet, Florian and Pauli-Magnus, Christiane and O'Sullivan, Jack W. and Riedel, Nico and Roth, Jan A. and Sauermann, Mandy and Schandelmaier, Stefan and Schmitt, Andreas M. and Speich, Benjamin and Williamson, Paula R. and Hemkens, Lars G.. (2020) The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days. F1000Research, 9. p. 1193.

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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.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung
03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB
10 Zentrale universitäre Einrichtungen > Universitätsbibliothek
UniBasel Contributors:Appenzeller-Herzog, Christian and Saccilotto, Ramon and Ewald, Hannah and Pauli-Magnus, Christiane and Roth, Jan Adam and Sauermann, Mandy and Schandelmaier, Stefan and Schmitt, Andreas and Hemkens, Lars G.
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:F1000Research
ISSN:2046-1402
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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edoc DOI:
Last Modified:02 Nov 2020 08:48
Deposited On:02 Nov 2020 08:48

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