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