Christine Lee1, Christopher St Clair2, Cdr Christine Merenda3, Capt Richardae Araojo4, Sara Ray5, Derrick Beasley6, Radm Denise Hinton7. 1. Office of Minority Health and Health Equity, U.S. Food and Drug Administration, USA. Electronic address: ChristineS.Lee@fda.hhs.gov. 2. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA. Electronic address: Christopher.StClair@fda.hhs.gov. 3. Office of Minority Health and Health Equity, U.S. Food and Drug Administration, USA. Electronic address: Christine.Merenda@fda.hhs.gov. 4. Office of Minority Health and Health Equity, U.S. Food and Drug Administration, USA. Electronic address: Richardae.Araojo@fda.hhs.gov. 5. Inspire, USA. Electronic address: sararay@inspire.com. 6. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA. Electronic address: Derrick.beasley@fda.hhs.gov. 7. Office of the Chief Scientist, U.S. Food and Drug Administration, USA. Electronic address: denise.hinton@fda.hhs.gov.
Abstract
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. Published by Elsevier Inc.
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. Published by Elsevier Inc.
Authors: Gregg Harry Rawlings; Nigel Beail; Iain Armstrong; Robin Condliffe; David G Kiely; Ian Sabroe; Andrew R Thompson Journal: BMJ Open Date: 2020-12-07 Impact factor: 2.692