5 papers
Regulatory Expectations for Bayesian Methods in Drug and Biologic Clinical Trials: A Practical Perspective on FDA's 2026 Draft Guidance
Yuan Ji, Ph. D
The U.S. Food and Drug Administration (FDA) released a landmark draft guidance in January 2026 on the use of Bayesian methodology to support primary inference in clinical trials of…
Precision Dose-Finding Design for Phase I Oncology Trials by Integrating Pharmacology Data
Kyong Ju Lee, Yuan Ji
Phase I oncology trials aim to identify a safe dose - often the maximum tolerated dose (MTD) - for subsequent studies. Conventional designs focus on population-level toxicity model…
Dynamic borrowing from historical controls via the synthetic prior with covariates in randomized clinical trials
Daniel E. Schwartz, Yuan Ji, Li Wang
Motivated by a rheumatoid arthritis clinical trial, we propose a new Bayesian method called SPx, standing for synthetic prior with covariates, to borrow information from historical…
BESS: A Bayesian Estimator of Sample Size
Dehua Bi, Yuan Ji
We consider a Bayesian framework for estimating the sample size of a clinical trial. The new approach, called BESS, is built upon three pillars: Sample size of the trial, Evidence…
PAM-HC: A Bayesian Nonparametric Construction of Hybrid Control for Randomized Clinical Trials Using External Data
Dehua Bi, Tianjian Zhou, Wei Zhong +1
It is highly desirable to borrow information from external data to augment a control arm in a randomized clinical trial, especially in settings where the sample size for the contro…