April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
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 […]
April 15, 2024
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a central hub that supports innovative approaches to clinical trials that […]
April 15, 2024
TOPLINE: Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested. METHODOLOGY: Combined pediatric dermatology-rheumatology clinics can improve patient outcomes […]
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