Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics
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
- 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
- Ciarleglio MM, Arendt CD, Makuch RW, Peduzzi PN: Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure. Contemp Clin Trials. 2015 Mar; 2015 Jan 9. PMID: 25583273
- Fucito LM, Latimer AE, Carlin-Menter S, Salovey P, Cummings KM, Makuch RW, Toll BA: Nicotine dependence as a moderator of a quitline-based message framing intervention. Drug Alcohol Depend. 2011 Apr 1; 2010 Oct 30. PMID: 21036492
- Mullen KM, Vohr BR, Katz KH, Schneider KC, Lacadie C, Hampson M, Makuch RW, Reiss AL, Constable RT, Ment LR: Preterm birth results in alterations in neural connectivity at age 16 years. Neuroimage. 2011 Feb 14; 2010 Nov 10. PMID: 21073965
- Myers EH, Hampson M, Vohr B, Lacadie C, Frost SJ, Pugh KR, Katz KH, Schneider KC, Makuch RW, Constable RT, Ment LR: Functional connectivity to a right hemisphere language center in prematurely born adolescents. Neuroimage. 2010 Jul 15; 2010 Mar 25. PMID: 20347043
- Gozzo Y, Vohr B, Lacadie C, Hampson M, Katz KH, Maller-Kesselman J, Schneider KC, Peterson BS, Rajeevan N, Makuch RW, Constable RT, Ment LR: Alterations in neural connectivity in preterm children at school age. Neuroimage. 2009 Nov 1; 2009 Jun 25. PMID: 19560547
- O'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW: Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun; 2008 Sep 17. PMID: 18796184
- Schafer RJ, Lacadie C, Vohr B, Kesler SR, Katz KH, Schneider KC, Pugh KR, Makuch RW, Reiss AL, Constable RT, Ment LR: Alterations in functional connectivity for language in prematurely born adolescents. Brain. 2009 Mar; 2009 Jan 21. PMID: 19158105
- Ment LR, Kesler S, Vohr B, Katz KH, Baumgartner H, Schneider KC, Delancy S, Silbereis J, Duncan CC, Constable RT, Makuch RW, Reiss AL: Longitudinal brain volume changes in preterm and term control subjects during late childhood and adolescence. Pediatrics. 2009 Feb. PMID: 19171615
- Leeman RF, McKee SA, Toll BA, Krishnan-Sarin S, Cooney JL, Makuch RW, O'Malley SS: Risk factors for treatment failure in smokers: relationship to alcohol use and to lifetime history of an alcohol use disorder. Nicotine Tob Res. 2008 Dec. PMID: 19023831
- Constable RT, Ment LR, Vohr BR, Kesler SR, Fulbright RK, Lacadie C, Delancy S, Katz KH, Schneider KC, Schafer RJ, Makuch RW, Reiss AR: Prematurely born children demonstrate white matter microstructural differences at 12 years of age, relative to term control subjects: an investigation of group and gender effects. Pediatrics. 2008 Feb. PMID: 18245422
- Ciarleglio MM, Makuch RW: Hierarchical linear modeling: an overview. Child Abuse Negl. 2007 Feb; 2007 Feb 22. PMID: 17320172
- Ment LR, Peterson BS, Vohr B, Allan W, Schneider KC, Lacadie C, Katz KH, Maller-Kesselman J, Pugh K, Duncan CC, Makuch RW, Constable RT: Cortical recruitment patterns in children born prematurely compared with control subjects during a passive listening functional magnetic resonance imaging task. J Pediatr. 2006 Oct. PMID: 17011320
- Ment LR, Peterson BS, Meltzer JA, Vohr B, Allan W, Katz KH, Lacadie C, Schneider KC, Duncan CC, Makuch RW, Constable RT: A functional magnetic resonance imaging study of the long-term influences of early indomethacin exposure on language processing in the brains of prematurely born children. Pediatrics. 2006 Sep. PMID: 16950986
- Woods SW, Gueorguieva RV, Baker CB, Makuch RW: Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. Arch Gen Psychiatry. 2005 Sep. PMID: 16143728
- Ment LR, Vohr BR, Makuch RW, Westerveld M, Katz KH, Schneider KC, Duncan CC, Ehrenkranz R, Oh W, Philip AG, Scott DT, Allan WC: Prevention of intraventricular hemorrhage by indomethacin in male preterm infants. J Pediatr. 2004 Dec. PMID: 15580211
- Ment LR, Vohr B, Allan W, Katz KH, Schneider KC, Westerveld M, Duncan CC, Makuch RW: Change in cognitive function over time in very low-birth-weight infants. JAMA. 2003 Feb 12. PMID: 12585948