The Center for Clinical Epidemiology and Biostatistics 12th Annual UPENN Conference on Statistical Issues in Clinical Trials will be held April 17. The topic is electronic health records (EHR) in randomized clinical trials. Registration opened January 3, and the program will include the following:

Case Studies

Denise Esserman, Yale University: From Screening to Ascertainment of the Primary Outcome Using EHR: Challenges in the Stride Trial

Steven Zeliadt, University of Washington: The Approach Trial: Assessing Pain, Patient-Reported Outcomes, and Complementary and Integrative Health

Richard Platt, Harvard University: The Impact-AFib Trial: Implementation of an RCT to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation

Matthew T. Roe, Duke University: Leveraging Electronic Health Record Data for Pragmatic Randomized Trials in Learning Health Care Systems in the United States: Lessons Learned from the Adaptable Trial

Overviews

Benjamin A. Goldstein, Duke University: Design Considerations for Running Health System–Based Trials Through the Electronic Health Record

Mark Levenson, US Food and Drug Administration: Regulatory Perspective on Performing RCTs in an EHR Environment

Statistical Methods

Patrick J. Heagerty, University of Washington: Addressing Heterogeneity in the Data, Design, and Analysis of Pragmatic Trials Embedded in Delivery Systems

Sebastien Haneuse, Harvard University: On Selection Bias Due to Missing Data in EHR-Based RCTs

Susan M. Shortreed, Kaiser Permanente Washington Health Research Institute: Using Real-World Data to Improve Trial Design

Jinbo Chen, University of Pennsylvania: Study Design Issues for Exploiting EHRs to Design Clinical Trials

Panel Discussion

Rebecca Hubbard, University of Pennsylvania

Ralph D’Agostino, Boston University

Bill Capra, Genentech