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Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. 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Robert Makuch is a Professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track. A graduate of the University of Connecticut (BA), University of Washington (MA – mathematics), and Yale University (MPhil, PhD), Professor 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 also worked for six months at the National Cancer Research Center in Tokyo, Japan.\\n

He also was heavily involved in HIV research from the mid 80's through the early-mid 90's. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients, and served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. He also worked closely with the Food and Drug Administration (FDA), developing and implementing more than 200 HIV studies. He also served as a 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. Another area of current interest involves detection of rare adverse drug events, especially in the post-marketing environment.

These areas of methodologic research evolved as a result of his continued interest (since the mid 1980s) in regulatory affairs science. In addition, Makuch developed a regulatory affairs track at YSPH for graduate and post-doctoral level students, and over the past 10 years has been the leader of more than 25 training programs for senior delegations of the Chinese Food and Drug Administration. His areas of medical application include cancer, HIV, arthritis, and cardiovascular disease.\\n

In 2003, Makuch received the American Statistical Association Fellow Award for his numerous contributions to the field. In 2008, Makuch was received a Distinguished Alumni Award from the University of Connecticut. In 2012, Makuch was nominated to serve on the University of Connecticut Dean's Advisory Board for the College of Liberal Arts and Sciences. He also has been a decades-long member of Phi Beta Kappa. He also developed a 5-year biostatistics training program in Japan, in collaboration with the Japanese government. His primary research interests continue to be methodologic issues in the design, conduct, analysis, and interpretation of clinical and large-population/epidemiologic studies. 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 to detect rare adverse events.\\n

\",\"photo\":{\"hiResUrl\":\"https://files-profile.medicine.yale.edu/images/a49db680-0922-49a7-8685-7953f8aaf97f\",\"url\":\"https://ysm-res.cloudinary.com/image/upload/v1/yms/prod/a49db680-0922-49a7-8685-7953f8aaf97f\",\"altText\":\"Robert Makuch\",\"width\":1600,\"height\":2400,\"imageVariants\":[{\"dimension\":\"Square\",\"url\":\"https://ysm-res.cloudinary.com/image/upload/v1/yms/prod/ceedec93-8e41-4a7a-9c3f-11503b8e9fd6\",\"width\":1600,\"height\":1600},{\"dimension\":\"Rectangle\",\"url\":\"https://ysm-res.cloudinary.com/image/upload/v1/yms/prod/7eef6778-d66d-4498-9902-7c634e475285\",\"width\":1600,\"height\":2000}]},\"gallery\":null,\"organizations\":[{\"id\":109207,\"name\":\"Biostatistics\",\"url\":\"http://publichealth.yale.edu/biostat/\"},{\"id\":118611,\"name\":\"Center for Biomedical Data Science\",\"url\":\"https://medicine.yale.edu/cbds/\"},{\"id\":109464,\"name\":\"Center for Nicotine and Tobacco Use Research at Yale (CENTURY)\",\"url\":\"https://medicine.yale.edu/psychiatry/century/\"},{\"id\":114820,\"name\":\"Office of Cooperative Research\",\"url\":\"http://ocr.yale.edu/\"},{\"id\":114951,\"name\":\"Regulatory Affairs Track\",\"url\":null},{\"id\":118812,\"name\":\"Yale Institute for Global Health\",\"url\":\"https://medicine.yale.edu/yigh/\"},{\"id\":109082,\"name\":\"Yale School of Public Health\",\"url\":\"http://publichealth.yale.edu/\"},{\"id\":110762,\"name\":\"Yale University\",\"url\":\"https://www.yale.edu/\"},{\"id\":109548,\"name\":\"YSPH Global Health Concentration\",\"url\":null}],\"appointmentOrganizations\":[{\"id\":109207,\"name\":\"Biostatistics\",\"url\":\"http://publichealth.yale.edu/biostat/\"}],\"educations\":[{\"degree\":\"PhD\",\"institution\":\"Yale University (1977)\"}],\"honors\":[{\"award\":\"Fellow, American Statistical Association\",\"awardingOrganization\":null,\"date\":\"\"},{\"award\":\"Member, Phi Beta Kappa\",\"awardingOrganization\":null,\"date\":\"\"}],\"services\":[],\"activities\":[{\"activityLocations\":[{\"id\":303,\"institution\":null,\"city\":null,\"region\":null,\"country\":\"Spain\",\"geoPoint\":{\"latitude\":40.463667,\"longitude\":-3.74922}},{\"id\":14,\"institution\":null,\"city\":null,\"region\":null,\"country\":\"United Kingdom\",\"geoPoint\":{\"latitude\":55.378051,\"longitude\":-3.435973}}],\"id\":2781,\"title\":\"Liver Cancer Prevention\",\"description\":\"This project is an ongoing collaboration in the conduct and analysis of a prospectively randomized controlled clinical trial to prevent/minimize liver disease.\",\"startDate\":\"2008-01-01T00:00:00\",\"endDate\":null},{\"activityLocations\":[{\"id\":87,\"institution\":null,\"city\":null,\"region\":null,\"country\":\"Japan\",\"geoPoint\":{\"latitude\":36.204824,\"longitude\":138.252924}}],\"id\":2782,\"title\":\"Osteoarthritis and Anti-Inflammatory Drugs\",\"description\":\"Professor Makuch conducts research into a systematic review for evaluation of tolerability of nonsteroidal anti-inflammatory drugs in osteoarthritis patients in Japan.\",\"startDate\":\"2008-01-01T00:00:00\",\"endDate\":null},{\"activityLocations\":[{\"id\":187,\"institution\":\"China State Food and Drug Admin\",\"city\":null,\"region\":null,\"country\":\"China\",\"geoPoint\":{\"latitude\":35.86166,\"longitude\":104.195397}}],\"id\":2783,\"title\":\"Public Health Training Program\",\"description\":\"Professor Makuch led a team to create a training program for Chinese officials at the China State Food and Drug Administration (sFDA). The program, which began in 2008, provides guidance in the creation and implementation of future directions and initiatives of the sFDA.\\n\",\"startDate\":\"2008-01-01T00:00:00\",\"endDate\":null}]},\"researchTab\":{\"research\":{\"description\":\"

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

\",\"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

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Makuch, Ph.D., Professor in the Division of Biostatistics at Yale School of Public Health, received the Distinguished Alumni Award from the University of Connecticut at a reception and banquet at its Alumni Center on April 17.\",\"thumbnail\":null,\"url\":\"/news-article/2677/\",\"isFeatured\":false,\"source\":null},{\"id\":\"2679\",\"bylineDate\":\"2008-04-21T04:00:00-04:00\",\"title\":\"China State Food and Drug Administration Participating in Yale School of Public Health Training Program\",\"summary\":\"A senior delegation from the China State Food and Drug Administration (sFDA) is participating in an 8-day training program on food and drug regulatory matters, held at the Yale School of Public Health (YSPH). A welcome ceremony took place on Sunday, April 13 and the program will end on the evening of April 22 with a formal delegation dinner attended by Paul Cleary, Ph.D., Dean of YSPH as well as Dr. Shuhui Qu, the Deputy Commissioner of the sFDA.\",\"thumbnail\":{\"url\":\"https://ysm-res.cloudinary.com/image/upload/v1/yms/prod/fe40b9da-77de-45c1-bbbc-778d7bc0a92a\",\"altText\":null,\"width\":100,\"height\":100,\"imageVariants\":[]},\"url\":\"/news-article/2679/\",\"isFeatured\":false,\"source\":null},{\"id\":\"4127\",\"bylineDate\":\"2005-12-13T05:00:00-05:00\",\"title\":\"Beta Blockers Not Effective in Preventing Gastroesophageal Complications from Cirrhosis\",\"summary\":\"Beta blockers are not effective in preventing development of varices—veins in the esophagus that can rupture and bleed—as a consequence of cirrhosis, according to a recent study by Yale School of Medicine researchers in the New England Journal of Medicine.\",\"thumbnail\":null,\"url\":\"/news-article/4127/\",\"isFeatured\":false,\"source\":null}]},\"locationsTab\":{\"addresses\":[{\"id\":2894,\"address\":{\"id\":580,\"officeName\":null,\"name\":null,\"addressLine1\":\"60 College Street\",\"addressLine2\":\"Ste 203\",\"city\":\"New Haven\",\"region\":\"CT\",\"country\":\"United States\",\"postalCode\":\"06510\"},\"geoPoint\":{\"latitude\":41.3035087,\"longitude\":-72.9319369},\"phones\":[],\"activeHours\":null,\"website\":null}]},\"metaData\":{\"title\":\"Robert Makuch, PhD\",\"description\":\"Robert Makuch is a Professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track. 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