Open Access. Powered by Scholars. Published by Universities.®
Physical Sciences and Mathematics Commons™
Open Access. Powered by Scholars. Published by Universities.®
Dissertations & Theses (Open Access)
Early phase adaptive clinical trial design; BMA-CRM design; Bridging Study; Bayesian Biosimilar Design; Calibrated Power Prior
Articles 1 - 1 of 1
Full-Text Articles in Physical Sciences and Mathematics
Novel Bayesian Adaptive Clinical Trial Designs In Early Phases, Haitao Pan
Novel Bayesian Adaptive Clinical Trial Designs In Early Phases, Haitao Pan
Dissertations & Theses (Open Access)
Early phase, or phase I and phase II, trials are the first step in testing new medicines that have been developed in the lab. The main goal of phase I clinical trials is to establish the recommended dose of new drugs for phase II trials. For the cytotoxic drugs, the goal is to find maximum tolerated dose (MTD). The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Therefore, dose escalation methods, especially Bayesian designs, are recommended to be used in phase I …