New Clinical Trial Approach For Urgently Needed Therapies Could Be On Horizon

Researchers at RTI Health Solutions, the Massachusetts Institute of Technology, the Medical Device Innovation Consortium, and the US FDA are creating a new statistical methodology for clinical trials that will balance the risk of giving patients an ineffective therapy against the risk of delaying therapy for patients who have few options.

The Medical Device Innovation Consortium has chosen the Michael J. Fox Foundation for Parkinson's Research to help it create a new statistical methodology for incorporating patients’ preferences into the design of clinical trials. Its decision was driven largely by the foundation’s large network of patients willing to share their experiences through the Fox Insight network.

MDIC is a Minneapolis-based non-profit collaboration of researchers from the device industry and US and Canadian federal agencies. On Oct. 18, it announced the start of the pilot collaboration with...

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