RESUMO
OBJECTIVES: To refine a method of collecting the data from various patient generated data sources to explore themes with high repeatability. FDA will acquire new insight into understanding the perspectives of patients and caregivers through analyses of multiple sources. DESIGN: Qualitative analysis of FDA archival data and social media data. SETTING: Two pilot studies assessing methodologies on differing unstructured data sources. Study 1: Opioid Use Disorder (OUD), analyzing OUD public docket comments and social media data. STUDY 2: Pulmonary Arterial Hypertension (PAH), utilizing FDA's PAH PFDD meeting transcripts and 1813 Online User Generated Content (UGC) posts. RESULTS: Through triangulation of data, FDA identified data overlaps (thus increasing confidence of data) and located information found only in certain sources. CONCLUSIONS: and Relevance: For research to be patient centric, leveraging technological advances and multiple patient experience data sources captures the patient perspective beyond clinical delivery and provides additional information and aids in understanding the picture of medical product functioning beyond controlled randomized clinical trials.