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Soko Setoguchi, MD, DrPH

Core Faculty

Soko Setoguchi, MD, DrPH is a cardiologist by training, board-certified internist, and epidemiologist, is Professor of Medicine, Director of Clinical Research Education, Director of Clinician Researcher Track, Medicine Residency Program, Department of Medicine, Rutgers Robert Wood Johnson Medical School (RWJMS) and Professor of Epidemiology at Rutgers School of Public Health. She is also Co-Director of the Master of Science in Clinical and Translational Science (MS-CTS) at Rutgers School of Graduate Studies. After her medical school and training in Cardiology in Japan, she completed her doctoral training in epidemiology at the Harvard School of Public Health. She was on the research faculty in the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and at Duke Clinical Research Institute. She then completed US residency training in Internal Medicine at University of North Carolina Hospital, Chapel Hill (2014-2016) and RWJMS in 2017.

Dr. Setoguchi is recognized as an international leader in the field of pharmacoepidemiology and comparative effectiveness research studying the health effects of medications, medical devices, and other medical products in populations. She has authored more than 130 peer-reviewed papers in leading medical journals and has been funded by both federal and non-federal sources for her pharmacoepidemiology research program. Her research uses real world data to perform health services and outcomes research and comparative effectiveness research for medications and implantable medical devices in patients with chronic disease. Her work is internationally regarded for its methodological rigor and creativity. Her research not only produced critical evidence to improve health outcomes of patients, but also advanced the methods in pharmacoepidemiology using large databases through new approaches linking multiple databases, linking mothers and babies within databases, and developing creative study designs and applications of sophisticated methods.

Dr. Setoguchi has led multiple initiatives and activities within the International Society of Pharmacoepidemiology, serving as chair/member of the organizing committee for the annual international and Asian conferences and a member of strategic committee for ISPE. She has been a member of several national committees and boards, including FDA’s Drug Safety and Risk Management Advisory Committee, review panels for NIH, PCORI, and AHRQ, and the editorial board for Pharmacoepidemiology and Drug Safety. She also serves as Specialty Chief Editor in Cardiovascular Drug Safety for Frontiers in Drug Safety and Regulation

Research Profile
Epidemiology, climate and health outcomes, cardiovascular health service/outcome research, device epidemiology, pharmacoepidemiology, health technology evaluation, data science

Select publications

  1. Setoguchi S, Glynn RJ, Avorn J, Mogun H, Schneeweiss S; Statins and the Risk of Lung, Breast, and Colorectal Cancer in the Elderly; Circulation, 115(1): 27-33, 2007.
  2. Palmsten K, Hernández-Díaz S, Huybrechts KF, Williams PL, Michels KB, Achtyes ED, Mogun H, Setoguchi S; Antidepressant Use Near Delivery and Risk of Postpartum Hemorrhage in a Nationwide US Cohort of Low Income Women; BMJ, 347: f4877, 2013.
  3. Setoguchi S, Stevenson LW, Stewart GC, Bhatt DL, Epstein AE, Desai M, Wiilams L, Chen CY; Healthy candidate bias limits assessment of clinical effectiveness for implantable cardioverter-defibrillators: a cohort study of older patients with heart failure; BMJ, 348: g2866, 2014
  4. Mi X, Hammill BG, Curtis LH, Lai CC, Setoguchi S; Use of the Landmark Method to Address Immortal Person-Time Bias in Comparative Effectiveness Research: A Simulation Study;. Statistics in Medicine, 35(26): 4824-4836, 2016
  5. Layton JB, Li W, Yuan J, Gilman JP, Horton DB, Setoguchi S. Heatwaves, medications, and heat-related hospitalizations in older Medicare beneficiaries with chronic conditions. PLos ONE in press 2020


June 2019 – March 2024
Disease Outcomes iN Older adults under extreme Heat, AiR pollution and Medication use (DO-NO-HARM)
NIH/NIA 1R01AG060232-01A1
Principal Investigator

March 2019 – February 2024
New Jersey Alliance for Clinical and Translational Science: NJ ACTS
Director, Degree Programs, TL1

June 2020 – May 2021
An Integrated Clinical Research Database for CF Patients and Families.
Cystic Fibrosis Foundation
Principal Investigator

April 2019 – March 2021
Modifying the Risk and Outcome of Heart Failure in Patients with Rheumatoid Arthritis.
Pfizer, Inc. Investigator Initiated Research WI236029.
Principal Investigator

January 2020 – December 2020
Validating Venous Thromboembolic Events in Administrative Data.
Pfizer-Japan, Inc.
Principal Investigator

November 2019 – October 2020
Characterizing the Acute Heart Failure Patient Population in Japan.
Bristol-Myers Squibb
Principal Investigator

January 2020 – December 2020
Real-World Safety of Tofacitinib in Patients with RA in Japan A Feasibility Assessment and Protocol.
Pfizer-Japan, Inc.
Principal Investigator

January 2020 – June 2022
Impact Of Air Pollution On Breast Cancer Treatment And Outcomes: A Pharmacoepidemiologic Approach Using US Cancer Cohorts and US Modeled Air Pollution
New Jersey Commission on Cancer Research Postdoctoral Training
Primary Mentor

January 2021 – January 2023
Immune Checkpoint Inhibitor Use and Adverse Events Among Individuals with Melanoma and Non-Small Cell Lung Cancer.
Robert Leet Patterson and Clara Guthrie Patterson Trust Mentored Research Award Clinical, Health Services and Policy Research
Primary Mentor