Leveraging Real-World Data and Shared Clinical Trial Data to Inform Regulatory Decision-Making, Yale University-Mayo Clinic CERSI
December 13, 2016
Joseph S. Ross, MD, MHS
Associate Professor of Medicine (General Medicine)
and of Public Health (Health Policy and Management)
Yale University School of Medicine
Nilay Shah, PhD
Associate Professor of Health Services Research
Mayo Clinic College of Medicine
About the Presentation
There has been an unprecedented growth in the availability and linkage of a wide variety of health- and non-health related data resources. They reflect routine, real-world clinical practice, in part driven by efforts to promote data transparency and open science. These data provide an opportunity to address a number of key research questions, ranging from medical product comparative effectiveness, to safety signal detection, to replicating randomized trials.
In this lecture, Drs. Shah and Ross provided an overview of one such data infrastructure, OptumLabs Data Warehouse, which contains longitudinal health information on over 150 million predominantly privately insured individuals, including administrative claims and electronic health records. Examples of research projects that have been undertaken using these data was provided.
They discussed the need for open science in clinical research, including reviewing prior studies on selective publication and selective outcome reporting, implications for clinical medicine and research, and the potential value of clinical trial data transparency.
The lecture gave an overview of the Yale University Open Data Access (YODA) Project, a unique effort whereby academic investigators are making the clinical trial data of several large medical product companies available to external researchers, including lessons learned. Finally, use of these data resources for regulatory decision-making was discussed.
About the Presenters
Joseph S. Ross, MD, MHS, is an Associate Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale University School of Medicine, a member of the Center for Outcomes Research and Evaluation at the Yale-New Haven Hospital, and an Assistant Director of the Robert Wood Johnson Foundation’s Clinical Scholars program at Yale. His expertise includes performance measure development and understanding the translation of clinical research into practice using health policy research methods. These methods are used to examine the use and delivery of higher quality care and to better understand issues related to pharmaceutical and medical device evidence development, postmarket surveillance, and clinical adoption. Dr. Ross has published more than 200 articles in peer-reviewed biomedical journals and is currently an Associate Editor at JAMA Internal Medicine.
Nilay Shah, PhD, is a health services researcher in the division of Health Care Policy and Research at Mayo Clinic and an Associate Professor of Health Services Research in the Mayo Clinic College of Medicine. He is currently the co-director of the Late Stage Translation Unit, a part of the Mayo Center for Translational Science Activities (CTSA). He is also the Scientific Director for the OptumLabs Initiative in the Center for Science of Health Care Delivery at Mayo Clinic. Nilay’s research focus is on improving chronic care delivery, especially for patients with multiple chronic conditions. His work incorporates a range of methodological tools including mathematical models, observational designs, and prospective trials. In addition, he is involved in numerous studies to test the role of decision support tools for patient-centered knowledge translation and for translating comparative effectiveness research into routine clinical practice.