Presented by Distinguished VCU Biostatistics Alumnus
Frank W. Rockhold, Ph.D.
Professor of Biostatistics & Bioinformatics
Duke University Medical Center and Duke Clinical Research Institute
Affiliate Professor
Virginia Commonwealth University
Abstract. Research Institutes globally consider Real World Data (RWD) as supportive information to Randomized Controlled Clinical Trials (RCTs) and specifically consider that such data can serve as evidence to confirm treatment effectiveness. 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 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. The benefits of relying on real-world data sources from electronic health records (EHRs) and medical claims data must be balanced against a clear understanding of the data provenance and characteristics of these resources. Data collected primarily for the health care of the patient can limit their fitness for research purposes. This talk will examine the role of EHR and claims data in PCT’s and review both the benefits and challenges involved.