Assessment of public and patient online comments in social media and food and drug administration archival data

Christine Lee; Christopher St Clair; Cdr Christine Merenda; Capt Richardae Araojo; Sara Ray; Derrick Beasley; Radm Denise Hinton

doi:10.1016/j.sapharm.2019.10.009

Assessment of public and patient online comments in social media and food and drug administration archival data

Res Social Adm Pharm. 2020 Jul;16(7):967-973. doi: 10.1016/j.sapharm.2019.10.009. Epub 2019 Oct 10.

Authors

Christine Lee¹, Christopher St Clair², Cdr Christine Merenda³, Capt Richardae Araojo⁴, Sara Ray⁵, Derrick Beasley⁶, Radm Denise Hinton⁷

Affiliations

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.

PMID: 31668550
DOI: 10.1016/j.sapharm.2019.10.009

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.

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

Humans
Opioid-Related Disorders* / drug therapy
Pilot Projects
Social Media*
United States
United States Food and Drug Administration