[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to […]

CDER Center for Clinical Trial Innovation (C3TI) Content current as of: 04/15/2024 Regulated Product(s) Topic(s)

Content and Format of the C3TI Demonstration Program Proposal The C3TI Demonstration Program proposal should include the information below and not exceed 10 pages. The sponsor […]

CDER established the CDER Center for Clinical Trial Innovation (C3TI) in April 2024 to enable and amplify innovative approaches to clinical trials that are designed to […]

Overview The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides the opportunity to test, implement, and scale the integration of innovation into clinical trials […]

How will C3TI impact regulatory review? C3TI is likely to have an impact on regulatory review of new drugs in several ways, such as: More efficient […]

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of […]

Selective Safety Data Collection (SSDC) offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection […]

C3TI aims to promote the adoption of pragmatic design elements to integrate randomized trials into clinical practice and improve coordination and collaboration between CDER and sponsors […]