Drugs

Bayesian Statistical Analysis Demonstration Project

The CDER Center for Clinical Trial Innovation says its Bayesian Statistical Analysis demonstration project provides a structured opportunity to use Bayesian approaches for the pre-specified primary analysis, supplementary analysis, or monitoring of simple trials, such as trials with a non-adaptive or straightforward sequential design. A Center online post says participating in the demonstration project gives sponsors additional CDER support to align on the statistical analysis plan and fosters collaboration with FDA/CDER subject matter experts in Bayesian statistics, encouraging knowledge exchange and methodological refinement.

The post lists these eligibility requirements for demonstration project proposals:

the sponsor must have an active pre-IND or IND for the product(s) in the proposal;
the trial must be a Phase 3 efficacy or safety trial with a simple design;
the Bayesian analysis may be used either for pre-specified primary analysis, supplemental analysis of the primary endpoint in the overall population or relevant subgroups, or trial monitoring; and
the demonstration project is intended for less complex applications or applications where the proposed method is more familiar.

Instructions for submitting a project proposal are here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome