Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database

Project Title Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database
Date Posted
Wednesday, April 23, 2014
Status
Complete
Deliverables
Description

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.

Workgroup Leader(s)

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

Workgroup Members

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

Data Sources
Mini-Sentinel Distributed Database (MSDD)
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