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# FDA Workshop on Evaluating RWE Observational Studies
- URL: https://www.fdaweb.com/fda-workshop-on-evaluating-rwe-observational-studies/
- Published: 2021-01-12T12:00:00.000Z
- Updated: 2026-09-14T16:42:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148431

FDA and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop focused on considerations about observational study design and conduct when using evidence from such studies to inform regulatory decisions. A workshop [announcement](https://www.fda.gov/drugs/news-events-human-drugs/workshop-evaluating-rwe-observational-studies-regulatory-decision-making-02162021-02172021?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the 2/16-17 event will highlight preliminary results from ongoing trial replication efforts to better understand the strengths and limitations of observational studies when considering their potential use in answering questions about drug product effectiveness and informing regulatory decision-making.

The conference also is to look at challenges with data adequacy and bias in observational studies that may affect causal inference, including provider and patient populations of the assigned treatment as well as differences in treatment adherence, the announcement says.