Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?


Journal

Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741

Informations de publication

Date de publication:
10 2020
Historique:
received: 01 05 2020
accepted: 13 05 2020
pubmed: 15 5 2020
medline: 30 9 2020
entrez: 15 5 2020
Statut: ppublish

Résumé

The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand-alone trials and observational studies of single-agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient-level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision-relevant clinical trials.

Identifiants

pubmed: 32407539
doi: 10.1002/cpt.1891
pmc: PMC7272975
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

730-733

Informations de copyright

© 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

Références

N Engl J Med. 2020 May 7;382(19):1787-1799
pubmed: 32187464
Lancet Infect Dis. 2020 Oct;20(10):1122-1123
pubmed: 32325035
Contemp Clin Trials Commun. 2018 Aug 07;11:156-164
pubmed: 30112460
Lancet. 2020 Apr 25;395(10233):1322-1325
pubmed: 32247324
N Engl J Med. 2020 Jun 11;382(24):2327-2336
pubmed: 32275812
Lancet. 2020 Apr 18;395(10232):1245-1246
pubmed: 32305088

Auteurs

Hans-Georg Eichler (HG)

European Medicines Agency (EMA), Amsterdam, The Netherlands.
Medical University of Vienna, Vienna, Austria.

Marco Cavaleri (M)

European Medicines Agency (EMA), Amsterdam, The Netherlands.

Harald Enzmann (H)

BfArM, Bonn, Germany.
EMA's Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.

Francesca Scotti (F)

European Medicines Agency (EMA), Amsterdam, The Netherlands.

Bruno Sepodes (B)

EMA's Committee for Medicinal Products for Human Use (CHMP), Amsterdam, The Netherlands.
Universidade de Lisboa, Lisbon, Portugal.

Fergus Sweeney (F)

European Medicines Agency (EMA), Amsterdam, The Netherlands.

Spiros Vamvakas (S)

European Medicines Agency (EMA), Amsterdam, The Netherlands.

Guido Rasi (G)

European Medicines Agency (EMA), Amsterdam, The Netherlands.
University Tor Vergata, Rome, Italy.

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Classifications MeSH