07/11/21
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, Diallo A, Trøseid M, Simensen VC, Boston A, Demotes J, Olsen IC, Chung F, Paiva JA, Hites M, Ader F, Arribas JR, Baratt-Due A, Melien Ø, Tacconelli E, Staub T, Greil R, Tsiodras S, Briel M, Esperou H, Mentré F, Eustace J, Saillard J, Delmas C, LeMestre S, Dumousseaux M, Costagliola D, Røttingen JA, Yazdanpanah Y
Editor: The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered new approaches in clinical research. These include the conduct of adaptive platform trials, such as RECOVERY [1], REMAP-CAP and DisCoVeRy [2]. Platform trials allow the study of several target treatments in the same disease context on a perpetual basis, with therapies being allowed to enter or leave the platform based on a decision algorithm [3]. DisCoVeRy is part of a European project, EU-RESPONSE, originally set up in France as a WHO Solidarity trial add-on study [4]. EU-RESPONSE is funded by the Horizon 2020 programme to allow the expansion of DisCoVeRy to other European/associated countries, and the launch of ‘EU-SolidAct’, a second-generation pan-European platform trial for coronavirus disease 2019 (COVID-19)/emerging infectious diseases, implemented to extend what was initiated by DisCoVeRy. These trials have faced multiple hurdles.