Enhancing Meaningful Engagement on Patient Experience Data in Drug Development

The use of patient experience data (PED) to inform the development and benefit-risk assessment of medical products and communicate value for patients is increasingly recognized by regulators, industry, patients, and payers. Industry have dedicated resources to this area and have placed a greater emphasis on collection of PED to inform various aspects of medical product development, such as understanding of a disease area, clinical trial design, endpoint selection, B-R assessment, etc. Ultimately, Industry wants to ensure that they are meeting the needs of patients by making clinical trials more accessible, measuring what matters most to them, and making the medical products accessible to them.

To appropriately collect and use PED to inform medical product development plans and regulatory decision making, it is critical for Industry to actively engage key stakeholders throughout the medical product development process and foster collaboration. In this session, we will explore perspectives from key stakeholders, including FDA, industry and patient representative and discuss opportunities to enhance meaningful engagements with key stakeholders on PED, including what are current challenges and opportunities, what are appropriate times to engage, and discuss available resources to ensure meaningful interactions. As one example of a resource for stakeholders, the BIO FDA-Sponsor Engagement framework for COAs will be presented.