RAPS

FDA issues guidance on use of Bayesian methods to support drug development

The US Food and Drug Administration (FDA) issued a draft guidance on Friday to assist sponsors in using Bayesian methods to support the safety and effectiveness of new drugs in clinical trials. These ...
RAPS

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
Medscape

FDA Changes Drug Trial Guidance: Experts Take Sides

The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development. But statisticians and researchers are divided on ...
insider.si.edu

Bayesian methods for data analysis / Bradley P. Carlin, Thomas A. Louis

Approaches for statistical inference -- The Bayes approach -- Bayesian computation -- Model criticism and selection -- The empirical Bayes approach -- Bayesian design -- Special methods and models -- ...
mccormick.northwestern.edu

MLDS 490: Bayesian Methods for Inference and Decision Making

This course offers a rigorous yet practical exploration of Bayesian reasoning for data-driven inference and decision-making. Students will gain a deep understanding of probabilistic modeling, and ...
ascopubs.org

Comparative Study of Bayesian Information Borrowing Methods in Oncology Clinical Trials

Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study We divided the borrowing ...
Nature

Bayesian Methods in Diagnostic Test Evaluation

Bayesian methods offer a coherent framework for evaluating diagnostic tests by combining prior knowledge with observed data to yield posterior estimates of test accuracy and disease prevalence. At the ...
JD Supra

FDA Modernizes Draft Guidance on Statistical Methods to Support Clinical Trial Data

Consistent with the Food and Drug Administration’s (FDA) commitment to streamlining the prescription drug and biologics approval processes by adopting innovative approaches to clinical trial design, ...
Nature

Bayesian Methods in Measurement Uncertainty Evaluation

Bayesian methods offer a coherent framework for quantifying and propagating uncertainty by combining prior knowledge with experimental data. Unlike classical ...
Reason

How To Speed Up the Search for Cures Through a Change in Probability Theory

Marty Makary was appointed commissioner of the Food and Drug Administration (FDA) in 2025. The prominent surgeon, medical researcher, bestselling author, and critic of the medical ...
eLife

High-frequency spike inference with particle Gibbs sampling

A Bayesian particle Gibbs framework enables unbiased spike time inference with millisecond resolution and jointly estimates uncertainties in both spike timing and model parameters from fast calcium ...