The Using Patient Preference Information in the Design of Clinical Trials (PPI-CT) Framework is focused on providing medical device clinical trial sponsors and the broader clinical trial community an actionable set of learnings and compendium of best practice...
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MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report
This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.” By...
Patient-Centered Clinical Trial Design Tool for Heart Failure Devices Methods Report
Clinical trials are designed based on a statistical approach to gain confidence that a product is safe and effective. However, traditionally, these statistical considerations have not quantitatively incorporated patients perspectives on benefit-risk tradeofffs. For...
Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report
MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...