Can we know when an observational study approximates a clinical trial? Answers from RCT DUPLICATE, REPEAT and HARPER

Shirley Wang, PhD

Dr. Wang is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School, Lead Epidemiologist for the Food and Drug Administration’s (FDA) Sentinel Innovation Center, and member of the PCORI Methodology Committee. She leads the Meta-Research in Pharmacoepidemiology program, with recent projects aimed at improving the transparency, reproducibility and robustness of evidence from healthcare databases (www.repeatinitiative.org) and informing when and how real-world evidence studies can draw causal conclusions to inform regulatory or other healthcare decision-making (www.rctduplicate.org). She is currently PI on multiple NIH R01s and is also funded by FDA. She has received 4 awards from international societies for her methods work.

Email: swang1@bwh.harvard.edu