Vanderbilt Kennedy Center

Frank E. Harrell, Jr., Ph.D.

Professor of Biostatistics and Chair of the Department

Contact Info

(615) 322-2001


S-2323 Medical Center North

Frank E. Harrell, Jr., Ph.D.


Dr Harrell received a PhD in Biostatistics from the University of North Carolina in 1979 under the direction of PK Sen. He was co-managing editor of the journal Health Services and Outcomes Research Methodology from 1998-2005, is an Associate Editor of Statistics in Medicine, is on the Editorial Board of American Heart Journal and Journal of Clinical Epidemiology, and is a consultant to FDA. Previously Dr Harrell was on the FDA Cardio-Renal Advisory Committee, a consultant to the FDA Arthritis Advisory Committee, an AHCPR (now AHRQ) study section, and was the director of the SUPPORT (Study to Understand Prognoses Preferences Outcomes and Risks of Treatment) Statistical Center for nine years. SUPPORT concerned end of life care and decision making of primarily elderly patients with one of 8 end-stage diseases.

As reflected in his 173 peer-reviewed publications, Dr Harrell has devoted his career to the study of patient outcomes in general and specifically to the development of accurate prognostic and diagnostic models and models for many other patient responses. Much of Dr Harrell's work has been applied to health services and outcomes research, technology evaluation, observational databases, and clinical trials. His primary methodologic research relates to development of reliable statistical models, quantifying predictive accuracy, modeling strategies utilizing data reduction methods, estimating covariable transformations, model validation methods, penalized estimation (shrinkage), and missing data imputation. He has researched methods to estimate how continuous predictors relate to outcomes without assuming linearity, showing the advantages of piecewise cubic polynomials or spline functions. All of this work has taken into account that a risk model's likely performance on a new subject sample should be the touchstone. He has extended Efron's bootstrap estimator of the "optimism" in a model's predictive accuracy to validate more complex survival and risk models. His book Regression Modeling Strategies with Applications to Linear Models, Logistic Regression, and Survival Analysis (2001, Springer-Verlag) contains theory, examples, and detailed case studies demonstrating the use of many modern statistical modeling tools.

Dr Harrell spent 17 years in the Biometry and Cardiology Divisions and the Clinical Research Institute of Duke University Medical Center, where he taught the Regression Modeling Strategies course to fellows in the Masters of Health Sciences in Biometry Program (now the M.S. in Clinical Investigation Program) and mentored many fellows, mostly from the Department of Medicine. In 1996 Dr. Harrell founded the Division of Biostatistics and Epidemiology in the Department of Health Evaluation Sciences at the University of Virginia. There he taught Statistical Computing and Graphics, Biostatistical Modeling, and Advanced Data Analysis and assisted in the teaching of Clinical Trials Methodology, Comprehensive Introduction to Clinical Investigation, and Statistical Thinking in Biomedical Research. He directed the Clinical Investigation Track of the M.S. in Health Evaluation Sciences program, and was a co-director in the T21 and K30 clinical investigation training grants for complementary and alternative medicine, at UVa. Overall, Dr Harrell has taught biostatistics and research methodology to hundreds of physicians since the early 1980s, and has overseen research projects of dozens of medical fellows. In 2003 Dr Harrell became the founding chair of the Department of Biostatistics at Vanderbilt. His new area of emphasis is pharmaceutical safety, related to developing better ways to present safety information to data monitoring committees and developing new methods for pharmaceutical researchers to explore clinical chemistry, hematology, adverse events, and ECG data in Phase II and III randomized clinical trials.


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