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This presentation explores how to consistently and comprehensively capture the patient’s voice by using multiple data sources, including unstructured FDA archival data and social media.
FDA’s regulatory mission relies on sourcing new data and methodologies to increase our comprehensive understanding of the patient’s voice. Leveraging technological advances and multiple real-world evidence data sources, including FDA’s archival data and social media, such as Twitter and Facebook, has enabled FDA to acquire new insight into understanding the perspectives of caregivers and patients beyond the clinic. It has also given us a more comprehensive picture of medical products functioning beyond controlled randomized clinical trials.
Collectively, the findings of this study suggest opportunities to use new data sources to increase the total understanding of the patient perspective, including increasing confidence in the data that FDA traditionally collects, as well as reaching voices of vulnerable populations.
Christine Lee, PharmD, PhD
General Health Scientist, Office of the Center Director
FDA’s Center for Drug Evaluation and Research
Thursday, May 9, 2019
12:00 pm to 1:00 pm
Learn more and register here.
The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.