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FDA, Mini-Sentinel, and CTTI (the Clinical Trials Transformation Initiative) assessed the potential for conducting randomized trials in the Mini-Sentinel environment. This report details the Mini-Sentinel Data Partners’ experience, interest, and capability in partnering in the conduct of randomized trials. Topics addressed include: protocol development; identification of potential trial participants, engagement of providers, direct-to-patient engagement, and the role of policy interventions to effect change. The report includes use cases and an analysis of privacy and regulatory issues relevant to Mini-Sentinel data partners’ participation in clinical trials.
Additional Information
Contributors
Richard Platt, MD, MSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Pamela Tenaerts, MD, MBA; Clinical Trials Transformation Initiative, Durham, NC
Patrick Archdeacon, MD; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Elizabeth Chrischilles, PhD, MS; University of Iowa, College of Public Health, Iowa City, IA
Barbara Evans, PhD, JD; Center for Biotechnology & Law, University of Houston Law Center, Houston, TX
Adrian Hernandez, MD, MHS; Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, NC
Deven McGraw, JD, LLM; Center for Democracy and Technology, Washington, DC
Cheryl McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA
Marsha Raebel, PharmD; Kaiser Permanente Colorado, Denver, CO
Kristen Rosati, JD; Polsinelli, PC, Phoenix, AZ
John Buse, MD, PhD; Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, NC
Robert Califf, MD; Duke Translational Medicine Institute and Division of Cardiology, Duke University Medical Center, Durham, NC
Niteesh Choudhry, MD, PHD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Scott Connor, BS, Acurian, Inc., Horsham, PA
Jeffrey Curtis, MD, MS, MPH; Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL
Susan Ellenberg, PhD; Center for Clinical Epidemiology and Biostatistics, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Stephen Fortmann, MD; Center for Health Research Northwest, Kaiser Permanente Northwest, Portland, OR
Kenneth Hornbuckle, DVM, MPH, PhD; Office of Risk Management and Pharmacoepidemiology, Global Patient Safety, Eli Lilly and Company, Indianapolis, IN
Gabriella Lavezzari, PhD, MBA; Scientific Affairs, Pharmaceutical Research and Manufacturers of America, Washington, DC
Elliott Levy, MD; Global Pharmacovigilance and Epidemiology, Bristol-Meyers Squibb Co., Princeton, NJ
Leanne Madre, JD, MHA; Clinical Trials Transformation Initiative, Durham, NC
Elizabeth Mahon, JD; Johnson and Johnson, New Brunswick, NJ
Edward Mannello, RPh, MBA; AstraZeneca, Wilmington, DE
J. Stephen Mikita, JD; Clinical Trials Transformation Initiative, Patient Representative, Steering Committee, Salt Lake City, UT
Alvin Mushlin, MD, ScM; Weill Cornell Medical College, Department of Public Health, New York, NY
Vinit Nair, BSPharm, MS, RPh; Humana: Competitive Health Analytics, Inc. Louisville, KY
Jane Perlmutter, PhD; Clinical Trials Transformation Initiative, Patient Advocate, Ann Arbor, MI
Bruce Psaty, MD, PhD; University of Washington, Seattle, WA
Stephen Rosenfeld, MD, MBA; Quorum Review IRB, Seattle, WA
Claire Spettell, PhD; Aetna: Aetna Informatics, Blue Bell, PA