MDIC Project Looks To New P-Value Possibilities
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.
You may also be interested in...
The group that helped developed a framework to incorporate patient preference data into regulatory device submissions has released a new document to help in vitro diagnostics sponsors tackle the problem of limited sampling by using surrogate samples. The plan has been reviewed by top FDA officials.
FDA's new Patient Engagement Advisory Committee will discuss patient perspectives on device clinical trials at its first scheduled meeting.
US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.