Abstract
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.
Publisher
Cambridge University Press (CUP)
Reference20 articles.
1. 12. Food and Drug Administration. Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry. FDA, 2020. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/treatment-heart-failure-endpoints-drug-development-guidance-industry). Accessed October 4, 2023.
2. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
3. Procedures for Comparing Samples with Multiple Endpoints
4. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials.
5. Clinical trials of pharmacological therapies in acute heart failure syndromes;Felker;Circulation,2010