Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial.

Samvel B Gasparyan Joan Buenconsejo Elaine Kearney Kowalewski Jan Oscarsson Olof F BengtssonRussell EsterlineGary G KochOtavio BerwangerMikhail N Kosiborod

Published in: Therapeutic innovation & regulatory science (2022)

HCEs are flexible endpoints that can be adapted for use in different therapeutic areas, with win odds as the analysis method. DARE-19 is an example of a COVID-19 trial with an HCE as one of the primary endpoints for estimating a clinically interpretable treatment effect in the COVID-19 setting.

Keyphrases

coronavirus disease
sars cov
phase iii
study protocol
phase ii
clinical trial
randomized controlled trial
respiratory syndrome coronavirus
open label
combination therapy
replacement therapy
smoking cessation
data analysis