C3TI Demonstration Program CDER Center for Clinical Trial Innovation (C3TI) (+...)

https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/c3ti-demonstration-program?utm_medium=email&utm_source=govdelivery CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program Fosters Early Engagement with Drug Developers on Innovative Clinical Trial Approaches The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides an opportunity for drug developers to test and scale the integration of innovative approaches to clinical trial design and conduct. In this program, clinical trial sponsors can engage early with CDER review teams and subject matter experts in a structured and direct manner on innovative trial elements. A key objective of the C3TI Demonstration Program is to share insights related to the innovative elements of selected trials with the broader clinical trial community. To support this goal, participating sponsors and FDA will agree on what aspects of the development program can be shared publicly. Generally, participating sponsors will be expected to share select details of their clinical trials and the implementation of innovative approaches as the trials progress. This may include updates and insights that focus on general principles and innovative aspects while maintaining the necessary confidentiality of proprietary or sensitive information. The Demonstration Program accepts projects on a rolling basis and is open to selected sponsors conducting innovative clinical trials under a pre-investigational new drug application (pre-IND) or IND with CDER. These trials should be intended to support new drug approvals or changes to approved drug labeling. C3TI currently has three demonstration project areas: Bayesian Statistical Analysis Selective Safety Data Collection Streamlined Trials Embedded in clinical Practice More information about C3TI and its demonstration program, including eligibility criteria and how to submit a proposal, is available on the C3TI webpage. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti?utm_medium=email&utm_source=govdelivery