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@article{Janiaud:2020:10.12688/f1000research.26707.2,
author = {Janiaud, P and Axfors, C and van't, Hooft J and Saccilotto, R and Agarwal, A and Appenzeller-Herzog, C and Contopoulos-Ioannidis, DG and Danchev, V and Dirnagl, U and Ewald, H and Gartlehner, G and Goodman, SN and Haber, NA and Ioannidis, AD and Ioannidis, JPA and Lythgoe, MP and Ma, W and Macleod, M and Maliki, M and Meerpohl, JJ and Min, Y and Moher, D and Nagavci, B and Naudet, F and Pauli-Magnus, C and O'Sullivan, JW and Riedel, N and Roth, JA and Sauermann, M and Schandelmaier, S and Schmitt, AM and Speich, B and Williamson, PR and Hemkens, LG},
doi = {10.12688/f1000research.26707.2},
journal = {F1000Research},
pages = {1--19},
title = {The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days},
url = {http://dx.doi.org/10.12688/f1000research.26707.2},
volume = {9},
year = {2020}
}

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TY  - JOUR
AB  - 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
AU  - Janiaud,P
AU  - Axfors,C
AU  - van't,Hooft J
AU  - Saccilotto,R
AU  - Agarwal,A
AU  - Appenzeller-Herzog,C
AU  - Contopoulos-Ioannidis,DG
AU  - Danchev,V
AU  - Dirnagl,U
AU  - Ewald,H
AU  - Gartlehner,G
AU  - Goodman,SN
AU  - Haber,NA
AU  - Ioannidis,AD
AU  - Ioannidis,JPA
AU  - Lythgoe,MP
AU  - Ma,W
AU  - Macleod,M
AU  - Maliki,M
AU  - Meerpohl,JJ
AU  - Min,Y
AU  - Moher,D
AU  - Nagavci,B
AU  - Naudet,F
AU  - Pauli-Magnus,C
AU  - O'Sullivan,JW
AU  - Riedel,N
AU  - Roth,JA
AU  - Sauermann,M
AU  - Schandelmaier,S
AU  - Schmitt,AM
AU  - Speich,B
AU  - Williamson,PR
AU  - Hemkens,LG
DO  - 10.12688/f1000research.26707.2
EP  - 19
PY  - 2020///
SN  - 2046-1402
SP  - 1
TI  - The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days
T2  - F1000Research
UR  - http://dx.doi.org/10.12688/f1000research.26707.2
UR  - https://f1000research.com/articles/9-1193/v2
UR  - http://hdl.handle.net/10044/1/83467
VL  - 9
ER  -

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