The NHC’s Patient-Focused Medical Product Development series builds upon our Clinical Outcome Assessment (COA) series, which we hosted between Nov. 2018-Dec. 2019. The series will continue to introduce COA-related topics, but also will cover a broader range of subjects, including patient preference research, patient engagement in clinical trial design, as well as medical device development. The NHC seeks to ensure that the NHC membership is prepared to engage in conversations on all aspects of PFMPD. It is complementary to our other workstreams, including our Case Examples, Patient Engagement Compensation and Contracting Toolbox, and Rubric to Capture the Patient Voice.

About Patient-Focused Medical Product Development

Patient-focused medical product development is a mechanism by which stakeholders, including but not limited to medical product developers, academics, and regulators, form a partnership with patients to enhance medical product development, throughout the research, regulatory, and reimbursement processes. It is built on the belief that:

• understanding patient experiences, goals, and needs leads to clinical trials that are more efficient and that measure outcomes patients really care about;
• more successful medical product development because potential barriers to uptake were identified and addressed earlier;
• and value/health technology assessment that evaluate drugs based on patient-defined value.

FDA’s Patient-Focused Drug Development Initiative 

The Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative began under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Originally, FDA’s PFDD initiative referred to a series of disease-specific meetings hosted by the FDA. Following each of these meetings, FDA published a Voice of the Patient summary report. Subsequently, a process was established for patient organizations to host their own PFDD meetings (see Externally-led PFDD). Under PDUFA VI, FDA committed to developing four guidances on PFDD. For the most up-to-date information, please visit the FDA’s PFDD website.