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Robert Makuch, PhD

Professor Emeritus of Biostatistics; Affiliated Faculty, Yale Institute for Global Health; Director, Regulatory Affairs Track

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Robert Makuch, PhD

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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


Research Interests

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

Public Health Interests

Maternal & Child Health; Regulatory Affairs; Pharmacoepidemiology

Selected Publications