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...
Project: Patient Preference Information in Device Trial Design
This project is focused on providing device clinical trial sponsors and the broader medical device community an actionable set of learnings and compendium of best practice information on approaches for integrating patient preference information (PPI) into clinical trial design. These learnings are derived from engaging experts and review of five recent projects that have been distilled into case examples, two of which focused on Parkinson’s disease and one on heart failure were MDIC-led efforts.
Some stakeholders suggest that patient preferences within a disease community may not align with traditional clinical outcome measures and can vary widely based on a variety of factors. Most stakeholders in the medical device ecosystem agree, however, that patient preference and clinical outcome measures should not be viewed as “either/or,” but rather as an area where important work needs to be done to align and integrate the two using reliable methods and sufficient basis for generalizability to the population under consideration. For this reason, development of robust quantitative tools offers the opportunity for sponsors and regulators to seek ways to better evaluate what matters most to patients in the product development and regulatory review processes.
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