*Advancing Adaptive Trial Design Methodology

The Food and Drug Administration is seeking to advance adaptive trial design methodology through a strategic investment focused on development, standardization, and implementation. This initiative targets three primary priority areas: the creation of Bayesian prior specification and sensitivity analysis frameworks, the application of adaptive trial designs specifically for medical device development and rare diseases, and the establishment of principled single-arm trial designs supported by robust inferential standards. Currently listed as a forecast, this opportunity is managed by the FDA with program inquiries directed to the CDRH Acquisition Liaison. The project aims to modernize clinical trial frameworks to improve efficiency and reliability in regulatory submissions across specialized medical fields.