Faculty

Robert W. Makuch, Ph.D.

Professor (Triennial)
Biostatistics

Phone: (203) 785-2842
Fax: (203) 785-6912
robert.makuch@yale.edu

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.

Curriculum Vitae

Education

Ph.D., Yale University, 1977

Awards and Honors

Fellow, American Statistical Association

Member, Phi Beta Kappa

Professional Services

Associate Editor, Child Abuse and Neglect

Reviewer for more than 30 leading medical/scientific journals

Member of numerous governmental Advisory Committees

Current Research Projects

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

Yale Affiliations

Fellow, Silliman College, Yale University

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.

Groszmann, R.J., Garcia-Tsao, G., Bosch, J., Grace, N, Burroughs, A.K., Planas, R., Escorsell, A., Garcia-Pagan, J.C., Gao, H., Patch, D., Matloff, D.S., and Makuch, R. for the Portal Hypertension Collaborative Group. Beta-Blockers to Prevent Gastroesophageal Varices in Patients with Cirrhosis. New England Journal of Medicine 353: 2254-2261, 2005.

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.

Zhao, S.Z., Wentworth, C, Burke, T.A., and Makuch, R.W. Drug Switching Patterns among Patients with Rheumatoid Arthritis and Osteoarthritis Using COX-2 Specific Inhibitors and Non-specific NSAIDS. Pharmacoepidemiology and Drug Safety 13: 277-287, 2004.

Schulman, S., Olson, M.K., and Makuch, R.W. Which Factors Shape and Limit the Role of the Center for Drug Evaluation and Research's Advisory Committees. Drug Information Journal 36: 281-289, 2002.