Choosing primary endpoints for clinical trials of health care interventions

Charlie McLeod, Richard Norman, Edward Litton, Benjamin R. Saville, Steve Webb, Thomas L. Snelling

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish
Article number100486
JournalContemporary Clinical Trials Communications
Volume16
DOIs
Publication statusPublished - 1 Dec 2019

Fingerprint

Clinical Trials
Delivery of Health Care
Health

Cite this

@article{8c2f6c23f66b41f8ba91cbc5fefe34f5,
title = "Choosing primary endpoints for clinical trials of health care interventions",
abstract = "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.",
keywords = "Biomarkers, Clinical trials, Endpoint determination, Outcome assessment, Research design, Surrogate",
author = "Charlie McLeod and Richard Norman and Edward Litton and Saville, {Benjamin R.} and Steve Webb and Snelling, {Thomas L.}",
year = "2019",
month = "12",
day = "1",
doi = "10.1016/j.conctc.2019.100486",
language = "English",
volume = "16",
journal = "Contemporary Clinical Trials Communications",
issn = "2451-8654",
publisher = "Elsevier",

}

Choosing primary endpoints for clinical trials of health care interventions. / McLeod, Charlie; Norman, Richard; Litton, Edward; Saville, Benjamin R.; Webb, Steve; Snelling, Thomas L.

In: Contemporary Clinical Trials Communications, Vol. 16, 100486, 01.12.2019.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Choosing primary endpoints for clinical trials of health care interventions

AU - McLeod, Charlie

AU - Norman, Richard

AU - Litton, Edward

AU - Saville, Benjamin R.

AU - Webb, Steve

AU - Snelling, Thomas L.

PY - 2019/12/1

Y1 - 2019/12/1

N2 - 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.

AB - 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.

KW - Biomarkers

KW - Clinical trials

KW - Endpoint determination

KW - Outcome assessment

KW - Research design

KW - Surrogate

UR - http://www.scopus.com/inward/record.url?scp=85075324616&partnerID=8YFLogxK

U2 - 10.1016/j.conctc.2019.100486

DO - 10.1016/j.conctc.2019.100486

M3 - Review article

VL - 16

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

M1 - 100486

ER -