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. 2022 Jan;28(1):1-5.
doi: 10.1016/j.cmi.2021.10.011. Epub 2021 Nov 8.

Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

EU-Response investigators group; Alpha Diallo  1 , Marius Trøseid  2 , Victoria Charlotte Simensen  3 , Anaïs Boston  2 , Jacques Demotes  4 , Inge Christoffer Olsen  3 , Florence Chung  5 , José Artur Paiva  6 , Maya Hites  7 , Florence Ader  8 , Jose Ramon Arribas  9 , Andreas Baratt-Due  10 , Øyvind Melien  11 , Evelina Tacconelli  12 , Thèrèse Staub  13 , Richard Greil  14 , Sotirios Tsiodras  15 , Matthias Briel  16 , Hélène Esperou  17 , France Mentré  18 , Joe Eustace  19 , Juliette Saillard  20 , Christelle Delmas  17 , Soizic LeMestre  21 , Marina Dumousseaux  22 , Dominique Costagliola  23 , John-Arne Røttingen  24 , Yazdan Yazdanpanah  25
Affiliations

Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

EU-Response investigators group et al. Clin Microbiol Infect. 2022 Jan.
No abstract available

Keywords: EU-RESPOSE; Financial hurdles; Legal hurdles; Platform trials; Regulatory hurdles.

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Figures

Fig. 1
Fig. 1
Flowchart highlighting the legal hurdles encountered in DisCoVeRy. Acronyms: CA, Consortium Agreement; CTA, Clinical Trial Agreement; CRO, Contract Research Organization; EN, English.
See this image and copyright information in PMC

References

    1. Mullard A. COVID-19 platform trial delivers. Nat Rev Drug Discov. 2020;19:501. - PubMed
    1. Ader F., Discovery French Trial Management Team Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. BMJ Open. 2020;10 - PMC - PubMed
    1. Woodcock J., LaVange L.M. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med. 2017;377:62–70. - PubMed
    1. WHO COVID-19 solidarity therapeutics trial. World Health Organization; 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-r... accessed July 2021. Available at:
    1. National Institute for Health Research (NIHR) – Written evidence (COV0041) https://committees.parliament.uk/writtenevidence/8275/pdf/ Available at: