- May 09, 2019
12:00 PM - 01:00 PM EDT
- Organized By:
Christine Lee, PharmD, PhD
General Health Scientist
Office of the Center Director
FDA’s Center for Drug Evaluation and Research
About the Presentation
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.
About the Presenter
Dr. Christine Lee earned her PharmD from the University of Buffalo and her PhD in Pharmaceutical Outcomes and Policy from the University of Florida. She is the Hypoglycemia Federal Interagency Workgroup Co-Lead for the HHS Federal Interagency Work group (FIW) of federal experts and nationally recognized scientists on the prevention of diabetes agents’ adverse drug events (ADE) comprising of representatives across multiple federal agencies and professional organizations.
Dr. Lee is an expert in social and behavioral sciences, decision analysis, and human behavioral theories. She is also classically trained in measurement, psychometrics, focus group testing and outcome analysis. Dr. Lee spearheads research and innovation in linking real-world, real-time data to dissemination strategies and implementation, and is the principal investigator for the Science of Engagement, a project funded through an FDA Office of the Chief Scientist OMH Intramural Research Grant. Her work includes structuring unstructured FDA materials as well as social media data to inform regulatory decision-making. Dr. Lee’s research includes harnessing new technologies in data mining and applying novel, scientifically rigorous, real-world data methodologies to gather timely and relevant information from patients and health care professionals. She is an expert at effectively implementing research into practice.