The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.
Real-world data (RWD) is transforming clinical research, augmenting existing randomized controlled trial (RCT) data to de-risk studies and improve generalizability. With regulators setting clearer ...
WASHINGTON, Jan. 20, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing ...
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 ...
We review Bayesian and Bayesian decision theoretic approaches to subgroup analysis and applications to subgroup-based adaptive clinical trial designs. Subgroup analysis refers to inference about ...