The Medical Device Innovation Consortium, FDA and the Michael J. Fox Foundation for Parkinson's Research are working on a project to design trials that look beyond requiring the standard cutoff p-value of 0.05 or less to judge statistical significance. Instead, they aim to establish statistical standards based on information about what risks versus benefits patients are willing to accept.
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.
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