JD Supra

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...

BioStem Technologies Highlights Alignment with FDA’s Openness to Bayesian Statistical Approaches in Clinical Research

BioStem remains committed to advancing evidence-based innovation in wound care through rigorous clinical research and real-world data analysis, supported by its proprietary BioRetain ® process and ...
The BMJ

FDA is now “open to bayesian statistics”: transformational change or new Pandora’s box?

The US Food and Drug Administration (FDA) is now “open to bayesian statistics,” contrasting this with the frequentist approach that the agency and the drug industry have historically relied on for ...
Nature

Bayesian Analysis of Time Series Data

Bayesian analysis offers a robust framework for deciphering the intricate dynamics of time series data. By treating unknown parameters as random variables, this approach incorporates prior information ...
Becker's Hospital Review

FDA proposes new framework for clinical drug trial designs

The FDA has released new draft guidance outlining the use of Bayesian methodologies in clinical trials for drugs and biologics. The guidance is intended to help sponsors apply modern statistical ...
JSTOR Daily

Multivariate Fay–Herriot Bayesian estimation of small area means under functional measurement error

Journal of the Royal Statistical Society. Series A (Statistics in Society), Vol. 180, No. 4 (OCTOBER 2017), pp. 1191-1209 (19 pages) Area level models, such as the Fay–Herriot model, aim to improve ...
JSTOR Daily

Bayesian Analysis of Proportional Hazards Models Built from Monotone Functions

We consider the usual proportional hazards model in the case where the baseline hazard, the covariate link, and the covariate coefficients are all unknown. Both the baseline hazard and the covariate ...