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US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

 
• By Sue Sutter

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Central hub
C3TI is CDER's new central hub for innovative clinical trial approaches. • Source: Shutterstock

A US Food and Drug Administration drugs center initiative to enhance clinical trial innovation includes projects targeting three topics that have long been the subject of discussion among agency leadership and industry.

The three initial demonstration project areas of the Center for Drug Evaluation and Research’s Center for

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