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UK Regulator Calls For More Patient Involvement In Trial Design

More Flexible Rules On GCP And IMPs Are Planned

 
• By Ian Schofield

UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.

3D illustration of 3 flows of spheres converging in a single row over black background
The UK wants to streamline its clinical trial rules and processes • Source: Alamy

The UK government has revealed plans to give patients more of a say in how clinical trials are designed and managed. It is also planning to update current its Good Clinical Practice principles to make sure they are “flexible and can be applied to a broad range of clinical trials.”

New rules are also being proposed for investigational medicinal products (IMPs), including risk-proportionate requirements for authorized IMPs used in trials,...

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