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.
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The Medical Device Innovation Consortium is launching a new pilot project with FDA and the Michael J. Fox Foundation to incorporate patient preference into device trials in a ‘scientifically valid way’, according to MDIC CEO Bill Murray, who spoke to MedTech Insight from the AdvaMed 2016 conference in Minneapolis. In our video interview, Murray discusses the project's aim to adjust the statistical design of a study for Parkinson's disease based on patients' willingness to accept risks.
CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.
News We're Watching: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.