MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials
MDIC created a “How-To” video to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations from the report to maximize patient input in the design and development of medical device clinical trials.
The first section trains viewers on how to involve patients to improve trial enrollment and aspects of trial protocols and design. The second section provides a case study example of how one sponsor has implemented these steps. The last section is a question-and-answer session with FDA-CDRH Patient Engagement leaders about how patient input can improve trials and generate information that can be used during regulatory discussions.
- Barry Liden, JD, Edwards Lifesciences
- Michelle Tarver, MD, PhD, FDA
- Owen Faris, PhD, FDA