Event Title

Clinical Trials Using Patient Health Data: Realities and Myths

July 10, 2025

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Research Triangle CERSI

Thursday, July 10, 2025
3:00 – 4:00 PM (Eastern Standard Time)

About the Presentation

The Substantial Evidence Amendment to FDA Regulations was updated in 2019 to consider Real World Data (RWD) as supportive to Randomized Controlled Clinical Trials (RCTs) and specifically “to consider such data and evidence to constitute substantial evidence”.  There is general agreement among trialists that the use of existing healthcare data also holds promise for making randomized trials more efficient and generalizable.  Regulators and the academic community have outlined a framework for evaluating the use of (RWD) in regulatory decision-making using randomized pragmatic clinical trials (PCTs), which are RCTs designed to inform clinical or policy decisions by assessing the real-world effectiveness of an intervention. These benefits of relying on real-world data sources must be balanced against a clear understanding of the data provenance and characteristics of the electronic health record (EHR) and claims data used in PCTs.   Data collected primarily for the health care of the patient can limit their fitness for research purposes.  This talk will examine the role of patient data in the design and evaluation of PCT’s and review some of the issues involved.  This will be supported by several useful and diverse examples.

About the Presenter

Frank Rockhold is fulltime Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Duke Clinical Research Institute, and Professor of Biostatistics at Virginia Commonwealth University.  His research interests include clinical trial design, data monitoring committees, benefit/risk evaluation, and pharmacovigilance, and he has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.   His career includes senior management positions in the pharmaceutical industry, including Senior Vice President of Biostatistics and Data Science and most recently as Chief Safety Officer and Senior Vice President for Pharmacovigilance at GSK and has held faculty appointments at six different universities.  Dr. Rockhold is past President of the Society for Clinical trials, has served as Chairman of the board for CDISC and is currently Chairman of the Board of the Frontier Research Foundation and an advisor to EMA.  Frank has been involved in over 100 Data Monitoring Committees.  He is a coauthor of the ICH (International Council for Harmonization) E9 (Biostatistics) and E10 (Control Groups) guidelines and widely published in across a wide variety of scientific journals.

Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is an Elected Fellow of the American Statistical Association, the Society for Clinical Trials, and the Royal Statistical Society.  He is an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.

Remote Access Information

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Recording

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Advance Registration NOT Required.

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