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Robert Makuch, PhD

Professor of Biostatistics and in the Child Study Center; Director, Regulatory Affairs Track; Affiliated Faculty, Yale Institute for Global Health; Director, Regulatory Affairs Track

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Robert Makuch, PhD

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Robert Makuch is a Professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track. A graduate of the University of Connecticut (BA), University of Washington (MA – mathematics), and Yale University (MPhil, PhD), Professor Makuch worked at the National Cancer Institute (NCI) and the World Health Organization’s International Agency for Research on Cancer early in his career. He also worked for six months at the National Cancer Research Center in Tokyo, Japan.

He also was heavily involved in HIV research from the mid 80's through the early-mid 90's. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients, and served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. He also worked closely with the Food and Drug Administration (FDA), developing and implementing more than 200 HIV studies. He also served as a Special Government Employee (SGE) to the FDA. He returned to Yale in 1986, and has worked extensively on methodologic issues in clinical trials and large population-based studies since. Another area of current interest involves detection of rare adverse drug events, especially in the post-marketing environment.

These areas of methodologic research evolved as a result of his continued interest (since the mid 1980s) in regulatory affairs science. In addition, Makuch developed a regulatory affairs track at YSPH for graduate and post-doctoral level students, and over the past 10 years has been the leader of more than 25 training programs for senior delegations of the Chinese Food and Drug Administration. His areas of medical application include cancer, HIV, arthritis, and cardiovascular disease.

In 2003, Makuch received the American Statistical Association Fellow Award for his numerous contributions to the field. In 2008, Makuch was received a Distinguished Alumni Award from the University of Connecticut. In 2012, Makuch was nominated to serve on the University of Connecticut Dean's Advisory Board for the College of Liberal Arts and Sciences. He also has been a decades-long member of Phi Beta Kappa. He also developed a 5-year biostatistics training program in Japan, in collaboration with the Japanese government. His primary research interests continue to be methodologic issues in the design, conduct, analysis, and interpretation of clinical and large-population/epidemiologic studies. Design and sample size considerations for Phase IV studies is another active research area, in which a new class of hybrid designs has been proposed for scientific and regulatory purposes to detect rare adverse events.

Education & Training

  • PhD
    Yale University (1977)


  • Liver Cancer Prevention
    Spain; United Kingdom 2008
    This project is an ongoing collaboration in the conduct and analysis of a prospectively randomized controlled clinical trial to prevent/minimize liver disease.
  • Osteoarthritis and Anti-Inflammatory Drugs
    Japan 2008
    Professor Makuch conducts research into a systematic review for evaluation of tolerability of nonsteroidal anti-inflammatory drugs in osteoarthritis patients in Japan.
  • Public Health Training Program
    China 2008
    Professor Makuch led a team to create a training program for Chinese officials at the China State Food and Drug Administration (sFDA). The program, which began in 2008, provides guidance in the creation and implementation of future directions and initiatives of the sFDA.

Honors & Recognition

Fellow, American Statistical Association
Member, Phi Beta Kappa

Departments & Organizations