US FDA's Device-Focused Patient Engagement AdComm Tackles Trial Challenges
FDA's new Patient Engagement Advisory Committee will discuss patient perspectives on device clinical trials at its first scheduled meeting.
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Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.
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.