Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses

Workshop  l  Tuesday, February 16 - Wednesday, February 17 



On Tuesday, February 16 from 1 p.m. - 5 p.m. ET, to Wednesday, February 17 from 1 p.m. - 3:30 p.m. ET, the Duke-Margolis Center for Health Policy, in coordination with the U.S. Food and Drug Administration, will hold a two-day virtual workshop focused on considerations about study design and conduct when using real-world evidence (RWE) from observational studies to inform regulatory decisions.

The meeting 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 will also focus on challenges with data adequacy and bias in observational studies that may affect causal inference, including provider and patient perceptions of the assigned treatment as well as differences in treatment adherence.

Panel discussions will explore how to realize benefits and identify gaps in knowledge and strategies for addressing those gaps. 


  • Mark McClellan, Duke-Robert J. Margolis, MD, Center for Health Policy
  • Jacqueline Corrigan-Curay, U.S. Food and Drug Administration

Panelists – Day 1:

  • Adrian Hernandez, Duke University
  • Nandita Mitra, University of Pennsylvania
  • Jennifer Graff, National Pharmaceutical Council
  • Gerald Dal Pan, U.S. Food and Drug Administration
  • Sebastian Schneeweiss, Harvard Medical School
  • William Crown, Brandeis University
  • Nilay Shah, Mayo ClinicJoseph Ross, Yale University
  • Miguel Hernán, Harvard T.H. Chan School of Public Health
  • Robert Temple, U.S. Food and Drug Administration

Panelists – Day 2:

  • Lucinda Orsini, ISPOR
  • Josie Briggs, Patient-Centered Outcomes Research Institute
  • Michele Jonsson-Funk, UNC Gillings School of Public Health
  • Robert Ball, U.S. Food and Drug Administration
  • John Concato, U.S. Food and Drug Administration
  • Frank Harrell, Vanderbilt University
  • Nancy Dreyer, IQVIA
  • Rob Reynolds, GlaxoSmithKline

To register for this two-day workshop, please visit the Duke-Margolis Center for Health Policy’s website.