Enhancing the Collection, Communication, and Use of Patient Experience Data: Current Status and Next Steps

Summary: This panel will provide updates on the current state of patient-focused drug development (PFDD) and discuss challenges and opportunities related to systematic collection, use, submission, and communication of patient experience data (PED) in medical product development and regulatory decision-making. Panelists will discuss best practices for stakeholders to ensure PED is rigorously collected and to inform regulatory decision-making and to drive effective communication with patients involved in PFDD throughout the development process.

Background: Stakeholders agree that incorporating the patient voice in medical product development is important to address unmet medical needs. Since the 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) and re-authorization of the Prescription Drug User Fee Amendments (PDUFA V), significant progress has been made around the use of PED to support and enhance PFDD. During this time, stakeholders have advanced their individual efforts in the collection and use of PED and continue to incorporate the patient voice in their decision-making. For example, PED has been and continues to be used to inform overall medical product development programs, support regulatory decision-making, and provide valuable information to patients diagnosed with a particular condition and their caregivers. At the same time, patient advocacy groups, FDA, and industry are noting opportunities for improvement in the collection, use, submission, and communication of PED, to ensure most impactful use of this important source of patient input. Moreover, patient advocacy groups have noted ways in which industry could more effectively communicate with patients throughout the medical product development process.

Goal of discussion: This discussion will update attendees on recent progress made in advancing PFDD, and discuss challenges and opportunities related to systematic collection, use, submission, and communication of PED in medical product development and regulatory decision-making. Panelists will discuss opportunities to modify internal processes to streamline regulatory discussions and, ultimately, submissions to ensure FDA reviewers are able to effectively leverage PED to inform regulatory decision making. This session also will share actionable ways in stakeholders can continue to advance the incorporation of the patient voice throughout the medical product development and regulatory review process.