OHRP Exploratory Workshop
Session C: Pragmatic Clinical Trials (PCT) – Challenges and Innovations in Getting Informed Consent
Moderator: Gregory E. Simon, M.D., M.P.H.
Kaiser Permanente Washington Health Research Institute
Dr. Gregory Simon is an investigator at Kaiser Permanente Washington Health Research Institute, psychiatrist in Kaiser Permanente’s Behavioral Health Service, and co-chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance. Dr. Simon completed residency training in internal medicine at the University of Washington, residency training in psychiatry at the Massachusetts General Hospital, and fellowship training in the Robert Wood Johnson Clinical Scholars program at the University of Washington. His research focuses on improving access to and quality of mental health care, especially for mood disorders. Specific areas of his research include improving treatment adherence, increasing the availability of effective psychotherapy, effectiveness of peer support, identifying and reducing risk of suicidal behavior, and comorbidity of mood disorders with chronic medical conditions. Dr. Simon currently leads the Mental Health Research Network, a National Institute of Mental Health (NIMH)-funded consortium of research centers embedded in 13 large health systems.
Ryan E. Ferguson, Sc.D., M.P.H.
U.S. Department of Veterans Affairs
Dr. Ryan Ferguson is the director of the VA Cooperative Studies Program Coordinating Center in Boston, MA, where he specializes in designing and conducting large multi-center randomized clinical trials. Dr. Ferguson joined the Cooperative Studies Program in 2001 and has since focused on clinical trial methodologies for conducting pragmatic comparative effectiveness trials. He currently serves as a co-principal investigator for the VA’s Point of Care (PoC) Research Program, which focuses primarily on pragmatic clinical trials and innovation in translational science. Dr. Ferguson is a research assistant professor in the Section of General Internal Medicine at the Boston University School of Medicine and a member of the Society for Clinical Trials, the Society for Epidemiologic Research, and the American Statistical Association.
Sarah M. Leatherman, Ph.D.
U.S. Department of Veterans Affairs
Dr. Sarah Leatherman is the associate director of the VA Cooperative Studies PoC Program in Boston, MA, where she oversees the design and conduct of embedded pragmatic clinical trials. Dr. Leatherman joined the Cooperative Studies Program in 2010 and has since focused on implementing pragmatic comparative effectiveness trials and promoting a learning healthcare system within the VA. As a trained biostatistician, she oversees the analytical integrity of the multiple databases required to execute these activities. Dr. Leatherman’s published work includes first-authored publications, abstracts, and presentations on pragmatic trials. She is also a member of the Society for Clinical Trials, the American Statistical Association, and the Caucus for Women in Statistics.
George J. Annas, J.D., M.P.H.
George Annas, Warren Distinguished Professor at Boston University, is the director of the Center for Health Law, Ethics, & Human Rights of Boston University School of Public Health, and a professor in Boston University’s School of Medicine and School of Law. He is the cofounder of Global Lawyers and Physicians, a transnational professional association of lawyers and physicians working together to promote human rights and health. Professor Annas has authored or edited 20 books on health law and bioethics, including Worst Case Bioethics, American Bioethics, The Rights of Patients (3d ed. 2004), and Standard of Care. He has written a bioethics-themed play, Shelley's Brain, and is Boston’s “oldest new stand-up comic.” Professor Annas is a fellow of the American Association for the Advancement of Science, member of the National Academy of Medicine, and former member of the National Academies’ Human Rights Committee.
Content last reviewed on August 16, 2018