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 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...
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...
Case Study: Using the MDIC Patient Centered Benefit-Risk Framework to Support an Expanded Indication
Some patients may require dialysis if their own bodies are unable to filter toxins from their blood. Hemodialysis is a type of dialysis in which blood is pumped from the body through a filter and then back into the body. Typically, in-clinic treatment requires...
A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...