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.
You may also be interested in...
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.
The Israeli company raised $16m to support its Augmented Respiration Technology, a novel approach for delivering oxygen directly into the venous system. The company expects to earn FDA clearance for first product by 2023.