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
Clin Microbiol Infect
.
2022 Jan;28(1):1-5.
doi: 10.1016/j.cmi.2021.10.011.
Epub 2021 Nov 8.
Authors
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
1
ANRS, Clinical Research Safety Department, France; INSERM, Clinical Research Safety Department, France.
2
Oslo University Hospital, Department of Rheumatology, Dermatology and Infectious Diseases, Norway.
3
Oslo University Hospital, Department of Research Support for Clinical Trials, Norway.
4
ECRIN, Director General, France.
5
Inserm Transfert SA, Department Collaborative Research Funding, France.
6
Centro Hospitalar Universitário de São João, Department of Critical Care Medicine, Portugal.
7
Erasmus Hospital, Infectious Diseases, Belgium.
8
Hospices Civils de Lyon, Service de Maladies Infectieuses et Tropicales, France.
9
La Paz University Hospital, Infectious Diseases Unit, Spain.
10
Oslo University Hospital, Department of Immunology, Norway.
11
Norwegian Institute of Public Health, Department of Assessment of Interventions, Norway.
12
University of Verona, Division of Infectious Diseases, University of Verona, Diagnostic and Public Health, Italy.
13
Centre Hospitalier de Luxembourg, Maladies Infectieuses, Luxembourg.
14
Paracelsus Medical University Salzburg, Laboratory of Immunological and Molecular Cancer Research, Austria.
15
National and Kapodistrian University of Athens - Faculty of Medicine, 4th Department of Internal Medicine, Greece.
16
University Hospital Basel, Clinical Research, Switzerland.
17
INSERM, Pôle de Recherche Clinique, France.
18
Hôpital Bichat Claude-Bernard, Epidémiologie, biostatistique et recherche clinique, France.
19
University College Cork, Clinical Research, Ireland.
20
INSERM, Project Manager Clinical Microbiology and Infection, France.
21
ANRS, Soutiens structurants à la recherche Gestion budgétaire et sites cliniques, France.
22
INSERM, Project Manager, France.
23
Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP), France.
24
Norwegian Institute of Public Health, Division of Infectious Disease Control, Norway.
25
INSERM, IAME, Hôpital Bichat - Claude-Bernard, Infectious Diseases Department, France. Electronic address: yazdan.yazdanpanah@inserm.fr.
PMID:
34763056
PMCID:
PMC8572734
DOI:
10.1016/j.cmi.2021.10.011
No abstract available
Keywords:
EU-RESPOSE; Financial hurdles; Legal hurdles; Platform trials; Regulatory hurdles.
MeSH terms
Adaptive Clinical Trials as Topic*
COVID-19*
European Union
Government Regulation
Humans
Pandemics