Devices

Lessons Learned from PPI Case Studies

Researchers from the Medical Device Innovation Consortium (MDIC), including an FDA representative, have produced a paper and framework to give clinical trial researchers and teams an opportunity to incorporate lessons learned from case studies on the use of patient preference information (PPI) into their clinical development programs. “As the body of evidence supporting the feasibility and value of patient preference studies and PPI grows,” the researchers write in an open-source article in Therapeutic Innovation & Regulatory Science, “stakeholders will develop additional confidence and comfort with using PPI to design the most streamlined and efficient clinical trials possible, yielding outcomes that systematically include the benefit-risk preferences of patients.”

Seeking to develop additional resources for medical device researchers to understand the benefits of and approaches to using PPI in clinical trial design, MDIC convened a working group of 17 representatives of medical device companies, regulators, and patient advocates. The experts identified these key considerations for industry sponsors and regulators interested in applying PPI to clinical trial designs:

pursuing existing opportunities to work with regulators to incorporate PPI in regulatory decision-making;
identifying novel endpoints for patient preference studies;
aligning on the “crosswalk” between attributes selected for a patient preference study and endpoints used in a clinical trial;
ensuring the applicability of PPI to the specific population who will use the medical device under study; and
applying the most appropriate methods to leverage PPI to inform the statistical evaluation of trial data.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome