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Thursday, May 9, 2019
12:00 p.m. - 1:00 p.m. EST
Register here for webcast (public attendees and FDA staff)
CE Credit Available
Presented by:
Christine Lee, PharmD, PhD
General Health Scientist
Office of the Center Director
FDA’s Center for Drug Evaluation and Research
About the Presentation:
Dr. Christine Lee will discuss her groundbreaking work on how to consistently and comprehensively capture the patient’s voice by using multiple data sources such as unstructured FDA archival data and social media.
FDA depends on sourcing new data and methodologies to increase its comprehensive understanding of the patient’s voice. By leveraging technological advances and multiple real-world evidence data sources--including FDA’s archival data and social media like Twitter and Facebook--FDA has been able to gain new insight into understanding the perspectives of caregivers and patients beyond the clinic. It has also given FDA a more comprehensive picture of medical products functioning beyond controlled randomized clinical trials.
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.
What you’ll learn from this FDA scientist:
- How to analyze unstructured FDA archival data and social media to consistently and comprehensively capture the patient’s voice.
- How to use qualitative methodology to explore unstructured data with high repeatability.
- The importance of overlapping multiple sources of data, including FDA archival data and social media data.
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