Robert Walter Makuch, PhD

Professor of Biostatistics and in the Child Study Center; Director, Regulatory Affairs Track; Director, Regulatory Affairs Track

Research Interests

Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics

Research Organizations

School of Public Health: YSPH Global Health Concentration

Center for Nicotine and Tobacco Use Research at Yale (CENTURY)

Faculty Research

Office of Cooperative Research

Yale Institute for Global Health

Research Summary

Professor Makuch's primary research interests involve methodologic issues in the design, conduct, and analysis of clinical studies. One area of particular interest is the appropriate design and analysis of active control equivalence studies, where he described in a series of papers how controls should be selected, how the sample size for these studies is determined, and what constitute appropriate methods of analysis. 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. Analytic areas of interest include prospective individual matching designs and methods for the analysis of longitudinal data. These methodological developments have been directed towards cancer and HIV. Dr. Makuch is currently developing a Biostatistics post-graduate program in Japan.

Specialized Terms: Clinical studies; Methodology

Extensive Research Description

  • Genetic and Brain Image Analysis of Premature Infants
  • Clinical Studies of Methods to Stop/Prevent Smoking
  • Biostatistical Design and Analysis Issues for Detection of Rare Adverse Events

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.
  • Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia.

    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.

  • Chen, Y.T. and Makuch, R.W.: Use of Meta-Analysis to Evaluate Medical Questions of Interest: An Application to Studies of Secondary Prevention of Acute Myocardial Infarction. Drug Information Journal, 33:1161-1171, 1999.

Full List of PubMed Publications

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Contact Info

Robert Walter Makuch, PhD
Office Location
60 College Street, Ste 203
New Haven, CT 06510
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Mailing Address
BiostatisticsPO Box 208034
60 College Street

New Haven, CT 06520-8034

Curriculum Vitae