Seamless phase 2/3 design for trials with multiple co-primary endpoints using Bayesian predictive power

• Published in: BMC medical research methodology Vol. 24; no. 1; pp. 12 - 13
• Main Authors: Yang, Jiaying, Li, Guochun, Yang, Dongqing, Wu, Juan, Wang, Junqin, Gao, Xingsu, Liu, Pei
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 17.01.2024; BioMed Central; BMC
• Subjects: Bayes Theorem; Bayesian predictive power; Bayesian statistical decision theory; Binomial distribution; Clinical trials; Co-primary endpoints; Conditional power; Experimental design; Humans; Hypotheses; Medical Futility; Medical research; Methods; Probability; Research Design; Response rates; Sample Size; Seamless phase 2/3 design; Success; Vaccines; China; Bayesian predictive power; Co-primary endpoints; Seamless phase 2/3 design; Conditional power

Seamless phase 2/3 design has become increasingly popular in clinical trials with a single endpoint. Trials that define success based on the achievement of all co-primary endpoints (CPEs) encounter the challenge of inflated type 2 error rates, often leading to an overly large sample size. To tackle...