Understanding the Use of Composite Endpoints in Clinical Trials

The Western Journal of Emergency Medicine
C Eric McCoy

Abstract

Clinicians, institutions, healthcare networks, and policymakers use outcomes reported in clinical trials as the basis for medical decision-making when managing individual patients or populations. Therefore, the choice of a valid primary endpoint is crucial for randomized controlled trials (RCT) to demonstrate efficacy of new therapies. Recent improvements in treatment, however, have led to a decline in the morbidity and mortality of several common diseases, resulting in a reduction in relevant outcomes that can be used as clinical trial endpoints. Composite endpoints have been used as a solution to maintain the feasibility of RCTs, particularly when facing low event rates, high cost, and long follow-up. However, the benefits of using composite endpoints must be weighed against the risks of misinterpretation by clinicians and policymakers, as incorrect interpretation may have a detrimental effect on patients and populations. This paper defines a composite endpoint, discusses the rationale for its use, and provides a practical approach to interpreting results to aid in medical decision-making.

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Citations

Sep 8, 2019·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·David BricenoAndrea Natale
Jul 17, 2020·Journal of Medical Economics·Stephen P McKenna, Alice Heaney
Sep 18, 2020·Biometrical Journal. Biometrische Zeitschrift·Eva CantagalloJulien Péron
Mar 11, 2020·Perspectives in Clinical Research·Priya Ranganathan, Rakesh Aggarwal
Apr 20, 2019·Clinical Journal of the American Society of Nephrology : CJASN·Scott L WeissBenjamin L Laskin
May 18, 2019·General Thoracic and Cardiovascular Surgery·Ryo KoideToru Mizuguchi
Feb 7, 2021·BMC Pregnancy and Childbirth·Dylan HermanRohan D'Souza
Mar 25, 2021·Transplantation·Paulo N MartinsUNKNOWN ILTS Special Interest Group “DCD, Preservation and Machine Perfusion”
May 19, 2021·Transplantation and Cellular Therapy·Haesook T KimDaniel J Weisdorf
Jul 23, 2021·American Journal of Clinical Dermatology·Marianne de Brito, Zenas Z N Yiu

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