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  5. Understanding the Use of Existing Real-world Data for Medical Product Evaluation - 03/30/2023
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Webcast | Virtual

Event Title
Understanding the Use of Existing Real-world Data for Medical Product Evaluation
March 30, 2023

March 30, 2023

Yale University – Mayo Clinic CERSI

Thursday, March 30th, 2023

Presented By


Joshua D. Wallach, PhD

Joshua D. Wallach, PhD
Assistant Professor
Department of Epidemiology
Rollins School of Public Health
Emory University


Rozalina McCoy, M.D. M.S.

Rozalina McCoy, M.D. M.S.
Associate Professor of Medicine
Vice Chair for Research
Mayo Clinic Division of Community Internal
Medicine, Geriatrics, and Palliative Care


About the Presentation

There has been growing interest in better understanding the potential of observational research methods in medical product evaluation and regulatory decision-making. Previously, as part of the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), we used linked claims and electronic health record (EHR) data to emulate two ongoing randomized controlled trials (RCTs), characterizing the populations and results of each RCT prior to publication of its results. In this presentation, we presented the results from our study comparing participants’ demographic and clinical characteristics and study results between the emulated trials, which used structured data from OptumLabs Data Warehouse, and the published RCTs. First, we discussed the feasibility of implementing the baseline participant characteristics included in the published RCTs using real-world data. Second, we compared the emulated trials and published RCTs for baseline patient characteristics and results of the primary and secondary endpoints. Lastly, we used our findings to provide insight into the advantages and challenges of conducting emulations of ongoing RCTs.

About the Presenter

Dr. Joshua D. Wallach is an Assistant Professor within the Department of Epidemiology in the Rollins School of Public Health at Emory University. He received his PhD and MS in Epidemiology and Clinical Research at Stanford and his postdoctoral training in regulatory science and transparency at Yale University. As an epidemiologist and meta-researcher, Dr. Wallach’s research falls within three main areas: meta-research and evidence synthesis; issues related to pharmaceutical regulation; and the use of observational methods and real-world data to inform regulatory and clinical decision making. Dr. Wallach is a member of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) and an affiliate of the Meta-Research Innovation Center at Stanford (METRICS).

Dr. Rozalina McCoy is Associate Professor of Medicine and Vice Chair for Research in the Mayo Clinic Division of Community Internal Medicine, Geriatrics, and Palliative Care in Rochester, Minnesota, where practices as a general internist and endocrinologist and serves as medical director of the Mayo Clinic Ambulance Community Paramedic Service. Dr. McCoy is a NIH-, FDA-, and PCORI-funded clinician scientist whose work leverages real-world data to improve the quality, equity, and accessibility of diabetes care. She is particularly interested in understanding the individual and structural factors that lead to poor glycemic control and heighten the risks of acute and chronic diabetes complications, with the goal of developing precision medicine tools and patient-centered care delivery models to improve diabetes care and health outcomes. Dr. McCoy received her undergraduate degree at Harvard, medical degree at Johns Hopkins, completed her medical training in internal medicine and endocrinology at Mayo Clinic, and has been on faculty at Mayo Clinic since 2015.


Link: https://www.youtube.com/watch?v=4Ven0alPavM

For Questions:

Please contact Ruize Li at Ruize.Li@fda.hhs.gov


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