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US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research

 
• By Sarah Karlin-Smith

The Center for Drug Evaluation and Research’s new Center for Clinical Trial Innovation (C3TI) may lead a “targeted” effort to update the FDA’s regulatory framework given advances in trial design and execution, CDER Director Patrizia Cavazzoni said. Industry already has asks.

three clipped large stacks of paper on a desk
The FDA wants to modernize its regulations related to clinical trial conduct. • Source: Shutterstock

The US Food and Drug Administration is exploring whether regulatory changes are needed to advance modern clinical trial designs as part of the Center for Drug Evaluation and Research’s newly launched Center for Clinical Trial Innovation (C3TI) initiative.

Key Takeaways

  • The FDA wants to make “targeted” regulatory changes that push sponsors to more modern trial design and conduct.

  • Pilots conducted through the newly launched Center for Clinical Trial Innovation (C3TI) will be built into the review process, potentially aiding active applications

Under C3TI, the FDA is “considering the role regulations play in the adoption of innovative approaches in clinical trials,” CDER Director Patrizia Cavazzoni said

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