Patient-Centered Clinical Trial Design for Heart Failure Devices via Bayesian Decision Analysis.
Shomesh E ChaudhuriPhillip AdamsonDean Bruhn-DingZied Ben ChaouchDavid GebbenLiliana Rincon-GonzalezBarry LidenShelby D ReedAnindita SahaDaniel SchaberKenneth SteinMichelle E TarverAndrew W LoPublished in: The patient (2023)
A Bayesian decision analysis is a systematic, transparent, and repeatable process for combining clinical and statistical significance, explicitly incorporating burden of disease and patient preferences into the regulatory decision-making process.