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‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

 
• By Sue Sutter

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Contortionist
A certain amount of contortion is involved in applying novel clinical trial approaches under current regs. • Source: Shutterstock

The US Food and Drug Administration’s recently launched Center for Clinical Trial Innovation (C3TI) is eyeing ways to make adoption of community-based, decentralized and other innovative trial approaches less of a contortion exercise due to outdated regulations.

Current standards do not preclude adoption of innovative trial designs and approaches, but they also do not make it easy,...

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