Bayesian joint models for multi-regional clinical trials

• Published in: Biostatistics (Oxford, England) Vol. 25; no. 3; pp. 852 - 866
• Main Authors: Bean, Nathan W, Ibrahim, Joseph G, Psioda, Matthew A
• Format: Journal Article
• Language: English
• Published: England Oxford Publishing Limited (England) 01.07.2024; Oxford University Press
• Subjects: Bayes Theorem; Bayesian analysis; Biostatistics - methods; Clinical trials; Clinical Trials as Topic - methods; Drug development; Humans; Information processing; Mathematical models; Models, Statistical; Multicenter Studies as Topic - methods; Pharmaceutical industry; Regional development; Rejection rate; Statistical methods; Survival; Survival Analysis; LEADER trial; Bayesian model averaging; Joint models; Bayesian clinical trials; Multi-regional clinical trials; Laplace approximation

In recent years, multi-regional clinical trials (MRCTs) have increased in popularity in the pharmaceutical industry due to their ability to accelerate the global drug development process. To address potential challenges with MRCTs, the International Council for Harmonisation released the E17 guidanc...