Robert W. Makuch
Email: robert.makuch@yale.edu
Robert W. Makuch, Ph.D., is an American quantitative scientist and biostatistician. Dr. Makuch currently serves as a tenured full professor in the Department of Biostatistics at the Yale School of Public Health (YSPH) and Director of the Regulatory Affairs Track. Dr. Makuch holds M.Phil. and Ph.D. degrees from Yale University.
Dr. 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 was a collaborator at the National Cancer Research Center in Tokyo, Japan, and was heavily involved in HIV research from the mid-‘80s through the early-mid ‘90s. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients. He served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. Dr. Makuch had worked closely including consulting with the Food and Drug Administration (FDA) as a vetted 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. Areas of methodologic interest involve detecting rare adverse drug events, especially in the post-marketing environment. Additional areas include his seminal insights early on in the design and analysis of non-inferiority trials and the analysis and interpretation of multi-regional clinical trials. These areas of methodologic research evolved due to his continued interest (since the mid-1980s) in regulatory affairs science. His medical application areas include environmental health, cancer, HIV, arthritis, and cardiovascular disease.
Dr. Makuch is well recognized for his expert statistical and regulatory advice to the pharmaceutical industry and national and international government regulatory agencies. In recognition of his expertise in regulatory affairs, Makuch trained the entire senior leadership of the Chinese Food and Drug Administration (CFDA) for over a decade. He has led more than twenty-five one-week intensive training sessions of the CFDA leadership at Yale and in China during this period.
In addition, Makuch developed a regulatory affairs track at YSPH for graduate and post-doctoral level students and has provided regulatory certificates of completion to students and senior leadership of the CFDA. He has traveled to China more than thirty times.
Dr, Makuch is an Elected Fellow of the American Statistical Association, cited for his expert statistical consultation with the government and the pharmaceutical industry and his innovative contributions to clinical studies' methodological design and analysis. In 2008, Makuch received a Distinguished Alumni Award from the University of Connecticut. From 2012 to 2022, Makuch has served on the University of Connecticut Dean's Advisory Board for the College of Liberal Arts and Sciences. He was elected to become a University of Connecticut Foundation Board Member in 2023. Dr. Makuch has been a decades-long member of Phi Beta Kappa.
