Rethinking the National Clinical Research Continuum

Recorded: December 8, 2021

The ecosystem of evidence generation is rapidly changing. The available data that could be used to inform clinical research is becoming more decentralized and the need for more diverse participation is being encouraged. As research entities, pharmaceutical companies, and health systems seek to adapt to this shift, they also face significant obstacles at all phases of clinical research such as cost, regulation, ability to recruit diverse patients, and access to the right clinical trial resources. This panel will discuss our speakers' experiences and actions that could be done today to reduce this friction to enable clinical trials to accelerate the discovery and development of innovative therapeutics by harnessing the power of everyday healthcare.

• Learn about the value of data sharing between institutes and health providers, learning networks, and how streamlining resources could take the burden off each individual research entity and democratize research opportunities available through primary care physicians.
• Discuss how researchers can diversify trial participant representation, no matter the trial site location or patient socioeconomic status, to include the historically understudied and reduce disparity in resulting therapies.
• Understand the research benefit of real-world evidence sourced from de-identified clinical data, its impact on the speed of trials from study to market and through post-study evaluation, and how real-world evidence is being encouraged through national policy.

Engage with us to help us rethink the historic evidence generation model and how to leverage data and technology to advance new medicine and therapies so patients get the treatment they need, and doctors get the information they need to deliver better care.

Speakers:

Martin Mendoza, PhD, Director of Health Equity, All of Us Research Program, National Institutes of Health

Biography

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Martin Mendoza, Ph.D., serves as the Director of Health Equity for the All of Us (AoU) Research Program at the National Institutes of Health (NIH). In this role, he provides leadership and high-level expertise on improving inclusion and equity in precision medicine and addressing health equity issues for AoU.

Prior to joining AoU, Martin served as Director of the Division of Policy and Data at the Office of Minority Health in the Office of the Secretary at the Department of Health and Human Services, providing leadership and direction in the development health policies and initiatives designed to address the elimination of health disparities and advance health equity. He was also previously the lead for extramural research for minority health in the Office of the Commissioner at the Food and Drug Administration (FDA). Martin is a recognized expert in clinical trial diversity and while at FDA, testified before Congress in support of diverse clinical research inclusion. He is also the primary author for the pivotal FDA guidance document "Collection of Race and Ethnicity Data in Clinical Trials.”

Prior to FDA, Martin served in the Division of Clinical Research at the NIH National Institute of Neurological Disorders and Stroke. He conducted his primary research training in the National Cancer Institute's Pediatric Oncology Branch and previously served at the National Human Genome Research Institute where he helped to map Human chromosome 7 as part of the Human Genome Project. Martin is a graduate of the University of Maryland Baltimore County and received his doctorate in cancer biology from the Johns Hopkins University.

Gideon Scott Gordon, PhD, Senior Health Informatics Officer, Office of Strategic Programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Biography

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Scott Gordon is a Senior Health Informatics Officer for the Office of Strategic Programs in the Center for Drug Evaluation and Research at FDA since 2016. Dr. Gordon is responsible for a range of activities to standardize data for clinical research, submissions to FDA, and post-market surveillance. A significant aspect of Dr. Gordon’s work includes a focus on “real-world data” derived from health information technology and other non-traditional sources for use as an adjunct to data from traditional clinical trials and current pharmacovigilance methods. In parallel, Dr. Gordon also works to standardize pharmaceutical quality and manufacturing data for submission to FDA.

Previously, Dr. Gordon worked at the Association for State and Territorial Health Officials (ASTHO) from 2011 with a focus on public health informatics, including interactions between federal, state, and local public health information systems and healthcare information technology such as the CDC’s National Syndromic Surveillance System. He entered the public health domain in 2005 as a subcontractor for the Department of Homeland Security for public health emergency preparedness activities with the Massachusetts Department of Public Health. Prior to a post-doctoral position at the Whitehead Institute for Biomedical Sciences, Dr. Gordon received his core scientific training with B.A. in Biology from Case Western Reserve University and a Ph.D. in Molecular Microbiology from Tufts University Medical School.

Gillian Bartlett-Esquilant, PhD, Associate Dean for Population Health & Outcomes Research, Co-Director of the Translational Biosciences PhD and Professor of Family & Community Medicine, University of Missouri

Biography

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Dr. Gillian Bartlett is the Associate Dean for Population Health and Outcomes Research at the School of Medicine at the University of Missouri where she is also a tenured Professor of Family & Community Medicine and Co-Director for the Translational Biomedical PhD program. She received her PhD in epidemiology from McGill in 2001 and her MSc in 1996. In 2014, she was awarded the Carrie M. Derick Award for Excellence in Graduate Teaching and Supervision for McGill University and the Faculty of Medicine Honour List for Educational Excellence. While completing a 10-year mandate as Research and Graduate Program Director at McGill, she led the development and successful accreditation of three training programs that now have over a hundred trainees enrolled – an MSc in Family Medicine, a PhD in Family Medicine and Primary Care and the Clinician Scholars Program which is an Enhanced Skills third year family medicine residency program focusing on research skills.

Dr. Bartlett specializes in implementation science for translation of evidence into clinical practice. Her current concentration is on convergence science and stakeholder engagement around health care utilization and outcomes for vulnerable populations; implementation of precision medicine using patient-oriented strategies; and the use of education innovations to advance the discipline of translation biomedicine. Dr. Bartlett is currently the Executive Director for the Network Coordinating Office of the Primary and Integrated Health Care Innovations (PIHCI) network.

David Hedges, PhD MS, Lead Data Scientist, Billings Clinic

Biography

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David Hedges is the lead data scientist at Billings Clinic where he has been establishing a rigorous data science and artificial intelligence program. This program includes both in-house and external research collaborations centered on accelerating operational and clinical transformation in the Billings Clinic hospital system. These research collaborations are dedicated to the development and discovery of actionable insights from real world electronic health data. Currently, David holds an affiliate faculty position in the Montana State University Department of Electrical and Computer Engineering as well as affiliate research capacity at the Mayo Clinic Department of Orthopedic Surgery and Sports Medicine.

David graduated with a bachelor’s degree in neuroscience and a doctorate in biochemistry from Brigham Young University in Provo, Utah, and a master’s degree in biomedical informatics from the University of Utah. He trained as a postdoctoral fellow at the Scripps Research Institute in La Jolla, California and at the Scientific Computing and Imaging (SCI) Institute at the University of Utah in Salt Lake City, Utah. When not in front of a computer screen, he enjoys hiking, mountain biking, backcountry skiing, fly fishing, and gardening and lives in Belgrade, Montana, where, with his wife, he tries and fails daily to establish order and build structure through applied pattern recognition with four young children and a dog.

Joseph Kliegman, PhD, Research Strategy Executive, Cerner (moderator)

Biography

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Dr. Joseph Kliegman is an investigator in cancer biology and immunology with over 14 years of experience in translational research and leads Cerner's federal life science strategy. Previously Dr. Kliegman managed innovation programs and science and technology policy at the National Science Foundation, and served as Chief Scientist at Nextjournal.com, where he developed a cloud-based data science platform for reproducible research.