Profile photo: Nancy C. Santanello

Nancy C. Santanello, MD, MS, FISPE

Dr. Santanello is a consultant in epidemiology, pharmacoepidemiology & safety, comparative effectiveness, real world evidence, clinical trial design and patient centered research.

Currently, she consults for the PhRMA Foundation programs on outcomes research and comparative effectiveness. Dr. Santanello also sits on the Biopharma External Advisory Board of the University of Medicine and Dentistry of New Jersey and the Arcadia University MPH Program Advisory Board.

Dr. Santanello is a physician-epidemiologist trained in Emergency Medicine and Preventive Medicine with a Masters of Science degree in Epidemiology. Dr. Santanello received her M.D. from Howard University and her M.S. from the University of Maryland.

Dr. Santanello’s areas of research interest include: the development and validation of outcome measures for use in clinical trials, trial and observational study design, adherence to therapy, satisfaction with and preference for therapy, clinical outcome assessments, patient reported outcomes, effectiveness studies, and drug and vaccine safety/ pharmacoepidemiology.

Dr. Santanello was a Medical Officer with the National Heart, Lung, and Blood Institute (NHLBI) Prevention and Demonstration Research Branch of the Division of Epidemiology and Clinical Applications conducting clinical trials, epidemiology studies and developing physician training and patient education materials. In 1991, Dr. Santanello joined Merck & Co. Inc. where she became the Vice President and Head of the Epidemiology Department.

In 1998 Dr. Santanello received the Merck Board of Directors Award, the Company’s highest honor, for her work in support of clinical and outcomes research measures for asthma. She is a Past President of the International Society for Pharmacoepidemiology (ISPE) and is a Fellow of ISPE (FISPE). She is a past member of the IMEDS Scientific Advisory Committee.

Dr. Santanello has been invited to speak at national and international meetings, including the Institute of Medicine, Brookings Institute, the US Food and Drug Administration, International Society of Quality of Life, ISPE, Asia Pacific Conference on Pharmacoepidemiology, American Thoracic Society, NIH PROMIS, China Society for Evidence Based Medicine, and the China FDA.

Dr. Santanello has published over 60 peer-reviewed manuscripts.


Jan 2015 – present, Independent Consultant

May 2007 – January 1, 2015, Vice President
Head of Epidemiology Department – CORE (Center for Observational and Real World Evidence), Merck Research Laboratories

June 2003 – May 2007, Executive Director
Head of Epidemiology Department – BARDS (Biosta Decision
Sciences), Merck Research Laboratories

Jan 2002 – June 2003, Executive Director
Epidemiology Department – BARDS, Merck Research Laboratories

Jan 1997 – Jan 2002, Senior Director
Epidemiology Department – BARDS, Merck Research Laboratories.1992 – 2004, Adjunct Professor
Temple University School of Pharmacy


University of Maryland
1988 : Epidemiology : M.S.
1987 : Preventive Medicine : Chief Resident
1986 : Preventive Medicine : Resident

Howard University Hospital
1985 : Emergency Medicine : Chief Resident
1982-84 : Emergency Medicine : Resident

Howard University
1982 : Medical Degree : M.D.

Marymount College
1971 : Bachelor of Arts : B.A.


  • Quinlan SC, Hawes JCL, Mines D, Ahmed S, Lanes S, Mehta V, Holick CN, Nancy Santanello NC, Mast TC.
    Performance of an administrative claims algorithm to estimate the incidence of pure red cell aplasia in chronic hepatitis C patients. Epidemiol Rep. 2015; 3:1.
  • Li Xiachun, Girman Cynthia J, Ofner Susan, Shen C, Brodovicz KG, Santanello N. Sensitivity Analysis of Methods for Active Surveillance of Acute Myocardial Infarction Using Electronic Databases. Epidemiology, November 11, 2014.
  • Norquist JM, Girman C, Fehnel S, DeMuro-Mercon C, Santanello N. Choice of recall period for patient-reported outcome (PRO) Measures: criteria for consideration. Quality of Life Research, 2012; 21:1013-1020.
  • Santanello, Nancy C. Evaluating Drug Effects In The Post-VIOXX World: There Must Be A Better Way by Dr. Jerry Avon. SCRIBE ISPE Newsletter: 14:4. ISPE Mid-Year Meeting Keynote Address, Florence, Italy, 2011, April 9-11.

Abstracts/Invited Presentations

  • Santanello, N. From Efficacy to Effectiveness: Real World Comparators in Real World Settings. Invited Presentation. Clinical Trials, An Evolving Art. Scientific Symposium. American Thoracic Society. Denver, CO. May 20, 2015
  • Santanello, N. Visioning the Future of Person-Reported Outcomes. Invited presentation. PROMIS Health Organization Inaugural Conference, Philadelphia, PA. May 15, 2015
  • Santanello N. The Role of Epidemiology in the Pharmaceutical Industry – 1985-2015. Invited presentation. Harry A. Guess Memorial Lecture, University of North Carolina School of Public Health, Chapel Hill, NC April 8, 2015
  • Santanello N. Including and measuring patient centricity in clinical research. Invited presentation Assessing and Improving Clinical Trial Performance Seminar. Mercerville, NJ. March 20, 2015.