Robert Walter Makuch PhD

Professor of Public Health (Biostatistics) and in the Child Study Center; Director, Regulatory Affairs Track

Departments & Organizations

Office of Student ResearchSchool of Public Health: BiostatisticsChild Study CenterCenter for Nicotine and Tobacco Use Research at Yale (CENTURY)

Research Interests

Clinical studies; Methodology more...


  • Ph.D., Yale University, 1977

Selected Publications

  • Wu, Y-Te. and Makuch, R.W. Detecting rare adverse events in post-marketing studies: sample size considerations. Drug Information Journal 40: 87-96, 2006.
  • Makuch, R.W. and Shi, R. Comparison of European vs. U.S. Drug Approvals: An Analysis of Discrepancies between Drug Product Approval by EMA and FDA. Therapeutic Innovation and Regulatory Science 48: 362-366, 2014.
  • Woods, S.W., Gueorguieva, R.V., Baker, C.B., and Makuch, R.W. Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. Archives of General Psychiatry 62: 961-970, 2005.



Latest News


Edit Profile