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# Bayesian Statistical Analysis Demonstration Project
- URL: https://www.fdaweb.com/bayesian-statistical-analysis-demonstration-project/
- Published: 2025-12-04T12:00:00.000Z
- Updated: 2026-09-14T15:28:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160324

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](https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/bayesian-statistical-analysis-bsa-demonstration-project?ref=fdaweb.com) 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](https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/c3ti-demonstration-program-proposal-submission?ref=fdaweb.com).