Online Program

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Thursday, September 13
Thu, Sep 13, 1:15 PM - 2:30 PM
Thurgood Marshall South
Real-World Safety Evaluation

Large Electronic Health Care Data Fit for Purpose as First or Last Resort? Thoughts on Data Quality and Study Design Considerations to Estimate Treatment Effect (300743)

*Rima Izem, CDER/FDA 

Keywords: Electronic healthcare data

Thoughts on use of electronic healthcare data in regulatory decision making usually fall into one of three groups: those “hopeful” for these data sources’ ability in informing decisions faster, cheaper and with more generalizable findings; those “dismissive” because administrative claims databases or electronic health records’ data quality cannot match randomized study’s data quality; OR those “suspicious/skeptical” because of notorious disagreements between randomized trials and observational study findings. This presentation will give some context and nuance to these thoughts using examples in the past decade of different decision making in safety and sources that supported them. This presentation will highlight the breadth of decision making, data quality and study design quality in safety studies with electronic healthcare data.