12th Annual Conference on Statistical Issues in Clinical Trials: Electronic Health Records (EHR) in Randomized Clinical Trials: Challenges and Opportunities

Wednesday, April 17, 2019 - 7:30am to 5:00pm

This conference is focused on "Electronic Health Records (EHR) in Randomized Clinical Trials: Challenges and Opportunities".

Speakers featuring case studies include:

DENISE ESSERMAN, PhD Yale University - "From Screening to Ascertainment of the Primary Outcome using EHR, Challenges in the STRIDE Trial",
STEVEN ZELIADT, PhD University of Washington - "The APPROACH Trial: Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health",
RICHARD PLATT, MD Harvard University - "The IMPACT-AFib Trial: IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation", and
MATTHEW T. ROE, MD 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".

Speakers featuring Statistical Methods include:

PATRICK J. HEAGERTY, PhD - University of Washington - "Addressing heterogeneity in the data, design, and analysis of pragmatic trials embedded in delivery systems",
SEBASTIEN HANEUSE, PhD - Harvard University - "On selection bias due to missing data in EHRbased RCTs",
SUSAN M. SHORTREED, PhD - Kaiser Permanente Washington Health Research Institute - "Using real-world data to improve trial design", and
JINBO CHEN, PhD - University of Pennsylvania - "Study design issues for exploiting EHRs to design clinical trials".

Also, talks by:

BENJAMIN A. GOLDSTEIN, PhD - Duke University - "Design Considerations for Running Health System Based Trials Through the Electronic Health Record" and
MARK LEVENSON, PhD - Food and Drug Administration - "Regulatory perspective to performing RCTs in an EHR environment".

A panel discussion including REBECCA HUBBARD, PhD (University of Pennsylvania), RALPH D’AGOSTINO, PhD (Boston University) and BILL CAPRA, PhD (Genentec) will close the conference.

See the conference website for more information and registration.

Event Type


University of Pennsylvania Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics, Epidemiology and Informatics


American Statistical Association
Society for Clinical Trials
National Institute of Statistical Sciences


University of Pennsylvania’s Perelman School of Medicine
Arthur H. Rubenstein Auditorium, Smilow Center for Translational Research
3400 Civic Center Boulevard
United States
12th Annual Conference on Statistical Issues in Clinical Trials