Trends in use of composite endpoints in clinical trials: A comparison between acute heart failure trials and COVID-19 trials

Lan Shi; Christopher John Lindsell; Dandan Liu

doi:10.1017/cts.2024.492

Trends in use of composite endpoints in clinical trials: A comparison between acute heart failure trials and COVID-19 trials

J Clin Transl Sci. 2024 Mar 8;8(1):e55. doi: 10.1017/cts.2024.492. eCollection 2024.

Authors

Lan Shi¹, Christopher John Lindsell², Dandan Liu¹

Affiliations

¹ Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
² Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA.

Abstract

Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly. We conducted a literature review to investigate the use of composite endpoints in acute heart failure and COVID-19 clinical trials. The results showed more frequent use of patient-oriented outcomes and ordinal composite endpoints in COVID-19 trials, which might be driven by global consensus on a set of common outcome measures.

Keywords: Acute heart failure; COVID-19; clinical trial; composite endpoint; patient-reported outcome.