Choosing primary endpoints for clinical trials of health care interventions.
Biomarkers
Clinical trials
Endpoint determination
Outcome assessment
Research design
Surrogate
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
received:
01
06
2019
revised:
29
10
2019
accepted:
09
11
2019
entrez:
5
12
2019
pubmed:
5
12
2019
medline:
5
12
2019
Statut:
epublish
Résumé
The purpose of late phase clinical trials is to generate evidence of sufficient validity and generalisability to be translated into practice and policy to improve health outcomes. It is therefore crucial that the chosen endpoints are meaningful to the clinicians, patients and policymakers that are the end-users of evidence generated by these trials. The choice of endpoints may be improved by understanding their characteristics and properties. This narrative review describes the evolution, range and relative strengths and weaknesses of endpoints used in late phase trials. It is intended to serve as a reference to assist those designing trials when choosing primary endpoint(s), and for the end-users charged with interpreting these trials to inform practice and policy.
Identifiants
pubmed: 31799474
doi: 10.1016/j.conctc.2019.100486
pii: S2451-8654(19)30248-0
pii: 100486
pmc: PMC6881606
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
100486Informations de copyright
© 2019 Published by Elsevier Inc.
Déclaration de conflit d'intérêts
The author(s) declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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