Industry, FDA and patient groups recognize the importance and value of patient input in the ideation, design, testing and approval of new medical device technologies, but often struggle to elicit and incorporate patient input in a meaningful way. Patients can identify outcomes that are meaningful, risks that they would be willing to tolerate, and practices that can decrease the burden of participation in clinical trials. MDIC is developing a suite of tools to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities. Panel attendees will learn about the development of these tools that they can implement in their own clinical trials to develop clinical trials that measure what matters to patients and that patients can complete. Learning Objectives:
Describe a model for using patient preference information to inform the protocol development and statistical design of clinical trials.
Understand methodologies for involving patients in study design to reduce barriers of participation.
Identify practices that can maximize retention and compliance of patients in clinical trials.