For Immediate Release: October 24, 2016

Mary Kuramoto
513-579-9911 x2523

Medpace Presentation at ISPOR Design and Operational Considerations for Hybrid Retrospective-Prospective Studies

CINCINNATI, OH — (October 24, 2016) – Matthew J. Page, PhD, MPP, Epidemiologist and Health Economist at Medpace, will be presenting at the ISPOR 19th Annual European Congress in Vienna, Austria.


Design and Operational Considerations for Hybrid Retrospective-Prospective Studies

Poster Code: PRM231

Location: G3

View the Poster

Comparing active prospective treatment or observational arms with data from historical (i.e., retrospective) controls can save time and money in the evaluation and assessment of investigational and marketed pharmaceutical and biologic products as well as medical devices. This hybrid approach is supported by the United States National Institutes of Health (NIH) and multiple health technology assessment bodies. Such hybrid studies generally involve integration of datasets from multiple electronic sources such as electronic data capture (EDC) systems for clinical trials and observational studies, and claims databases held by public and private payers. When conceptualizing a hybrid analytic approach, researchers should give thought to the use and potential repurposing of existing data sources, the structure of ”new” data sources (e.g., EDC) and planning analyses for individual, partially merged, and fully merged datasets.

This presentation will explore design and operational considerations for hybrid retrospective- prospective studies, including merging databases of different sizes and formats and analyzing data from individual and pooled datasets with a focus on which data can and should be captured, such as efficacy/effectiveness outcomes, healthcare resource utilization (HRU), and costs/claims. Based in the design and conduct of actual studies, the presentation will conceptualize a hybrid study design and targeted data management and analysis approach. Building on this example, the presentation will enumerate important data elements and design considerations for study start-up and ongoing management and analysis of singular studies that utilize one retrospective dataset (e.g., electronic health records (EHR)) and one prospective dataset (e.g., EDC) as well as multi-year, multi-dataset drug and disease registries that utilize large amounts of both prospective and retrospective data.


Matthew J. Page, PHD, MPP, Epidemiologist, Medpace

Matthew Page has a diverse background in academia and research. In addition to having taught college courses in epidemiology and biostatistics, he has more than 10 years of experience working with pharmaceutical and medical device companies to implement numerous observational epidemiologic and health economic methodologies.


Medpace is a scientifically-driven, global full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services for drug, biologic, and device programs. Medpace’s physician-led, high-science, and disciplined operating approach leverages regulatory and therapeutic expertise to accelerate the global development of safe and effective medical therapeutics across all major areas including oncology, cardiovascular, metabolic/diabetes, infectious disease, and neuroscience. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,300 people worldwide with operations in 35 countries.

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