PURPOSE: To characterize the current use and information included in the patient experience data summary section (PEDSS) and discuss potential modifications to ensure the content and format of the PEDSS is informative and valuable to multiple stakeholder groups.
DESCRIPTION: Patient-focused drug development (PFDD) is an initiative to systematically capture and meaningfully incorporate patients’ experiences, perspectives, needs, and priorities into the development and evaluation of drugs. Under the PFDD initiative, the FDA encourages sponsors to submit patient experience data (PED). Submitted information is summarized in tabular format in a section called Patient Experience Data Summary Section (PEDSS) and included in the product reviews of approved drugs. A review of this sections from recent drug approvals (n=97, 2018-2019) provides insights into the adoption and submission of patient experience data. Findings from the review will be presented along with examples and viewpoints regarding potential enhancements to the content, format and utilization of this section to optimize the value of the content communicated from the FDA, industry, patients and other relevant stakeholders.
