Many trials of hydroxychloroquine for SARS-CoV-2 were redundant and potentially unethical: an analysis of the NIH clinical trials registry.
COVID-19
Clinical trial regulation
Equipoise
Hydroxychloroquine
Randomized controlled trials
Research ethics
Journal
Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
11
05
2021
revised:
29
10
2021
accepted:
06
11
2021
pubmed:
16
11
2021
medline:
4
5
2022
entrez:
15
11
2021
Statut:
ppublish
Résumé
We sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. We identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020. Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10). Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.
Identifiants
pubmed: 34780978
pii: S0895-4356(21)00362-0
doi: 10.1016/j.jclinepi.2021.11.011
pmc: PMC8590481
pii:
doi:
Substances chimiques
Antiviral Agents
0
Hydroxychloroquine
4QWG6N8QKH
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
73-80Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
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