Robert Makuch, PhD
Professor Emeritus of BiostatisticsCards
Appointments
Additional Titles
Affiliated Faculty, Yale Institute for Global Health
Director, Regulatory Affairs Track
Contact Info
Appointments
Additional Titles
Affiliated Faculty, Yale Institute for Global Health
Director, Regulatory Affairs Track
Contact Info
Appointments
Additional Titles
Affiliated Faculty, Yale Institute for Global Health
Director, Regulatory Affairs Track
Contact Info
About
Titles
Professor Emeritus of Biostatistics
Affiliated Faculty, Yale Institute for Global Health; Director, Regulatory Affairs Track
Biography
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.
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.
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.
Appointments
Biostatistics
EmeritusPrimary
Other Departments & Organizations
- Biostatistics
- Center for Biomedical Data Science
- Center for Nicotine and Tobacco Use Research at Yale (CENTURY)
- Regulatory Affairs Track
- Yale Institute for Global Health
- Yale School of Public Health
- Yale Ventures
- YSPH Global Health Concentration
Education & Training
- PhD
- Yale University (1977)
Research
Overview
- 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
Medical Subject Headings (MeSH)
Research at a Glance
Yale Co-Authors
Publications Timeline
Research Interests
Charles Duncan, MD, FAANS
Guadalupe Garcia-Tsao, MD, FRCP
Walter Kernan, MD
Benjamin Bunney, MD
Joseph Piepmeier, MD, FAANS
John Elsworth, PhD
Infant, Premature
Smoking Cessation
Clinical Trials, Phase IV as Topic
Publications
2022
Association of exposure to ambient particulate matter with maternal thyroid function in early pregnancy.
Zhang X, Huels A, Makuch R, Zhou A, Zheng T, Xia W, Gaskins A, Makuch J, Zhu Z, Zhu C, Qian Z, Xu S, Li Y. Association of exposure to ambient particulate matter with maternal thyroid function in early pregnancy. Environmental Research 2022, 214: 113942. PMID: 35870505, DOI: 10.1016/j.envres.2022.113942.Peer-Reviewed Original ResearchRegional Brain Volume Abnormalities and Long-term Cognitive Outcome in Preterm Infants
Peterson B, Vohr B, Staib L, Cannistraci C, Dolberg A, Schneider K, Katz K, Westerveld M, Sparrow S, Anderson A, Duncan C, Makuch R, Gore J, Ment L. Regional Brain Volume Abnormalities and Long-term Cognitive Outcome in Preterm Infants. 2022, 215-223. DOI: 10.4324/9780203822937-21.Peer-Reviewed Original ResearchCitationsAltmetricConceptsRegional brain volumesLong-term cognitive outcomesBrain volumePreterm infantsRegional brain volume abnormalitiesMagnetic resonance imaging (MRI) scansCognitive outcomesTerm control childrenPerinatal risk factorsResonance imaging scansBrain volume abnormalitiesPreterm cohortRisk factorsImaging scansPreterm childrenHigh prevalenceVolume abnormalitiesBehavioral disturbancesControl childrenTerm controlsAbnormalitiesInfantsChildrenOutcomesCognitive measures
2020
Emergency Use Authorization for Remdesivir and Its Potential Implications
Ochoa Chaar CI, Makuch R. Emergency Use Authorization for Remdesivir and Its Potential Implications. Therapeutic Innovation & Regulatory Science 2020, 55: 270-271. PMID: 32880853, PMCID: PMC7471551, DOI: 10.1007/s43441-020-00212-5.Peer-Reviewed Original ResearchCitationsAltmetric
2017
Ability to Reach Low-Income Smokers Enrolled in a Randomised Controlled Trial Varies with Time of Month
Hawk K, Shi R, Weiss J, Makuch R, Toll B, Bernstein SL. Ability to Reach Low-Income Smokers Enrolled in a Randomised Controlled Trial Varies with Time of Month. The Journal Of Smoking Cessation 2017, 13: 227-232. PMID: 31452822, PMCID: PMC6709708, DOI: 10.1017/jsc.2017.23.Peer-Reviewed Original ResearchCitationsConceptsLow-income smokersWeek 4Week 1Time of monthTobacco dependence treatmentOne-month followControlled TrialsAcademic EDEmergency departmentDependence treatmentWeek 2SmokersLow-income populationsWeek 3Study participantsMonthsFollowPhone callsLow-income individualsSuccessful contactTrialsFuture studiesParticipantsCellphone serviceUrban communitiesStatistical Issues in Drug Research and Development
Makuch R, Pledger G, Hall D, Herson J, Hsu J. Statistical Issues in Drug Research and Development. 2017, 225-262. DOI: 10.1201/9780203738610-5.Peer-Reviewed Original ResearchCitations
2015
Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial
Bernstein SL, D’Onofrio G, Rosner J, O’Malley S, Makuch R, Busch S, Pantalon MV, Toll B. Successful Tobacco Dependence Treatment in Low-Income Emergency Department Patients: A Randomized Trial. Annals Of Emergency Medicine 2015, 66: 140-147. PMID: 25920384, PMCID: PMC4819432, DOI: 10.1016/j.annemergmed.2015.03.030.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsEmergency department patientsDepartment patientsUS EDsTobacco abstinence ratesGroup of smokersTobacco dependence treatmentMultivariable logistic modelingState Smokers' QuitlineLow incomeED smokersFaxed referralsQuitline referralQuitline useSecondary endpointsEligible subjectsPrimary outcomeIntervention armMedicaid insuranceNicotine patchNicotine replacementAbstinence ratesBooster callsIntervention subjectsControl armControl subjectsSelection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and Bayesian procedure
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. Contemporary Clinical Trials 2015, 41: 160-171. PMID: 25583273, DOI: 10.1016/j.cct.2015.01.002.Peer-Reviewed Original ResearchCitationsAltmetric
2014
Comparison of Drug Approvals in Europe Versus the United States
Makuch RW, Shi R. Comparison of Drug Approvals in Europe Versus the United States. Therapeutic Innovation & Regulatory Science 2014, 48: 362-366. PMID: 30235531, DOI: 10.1177/2168479013517103.Peer-Reviewed Original ResearchCitations
2012
How Do Perceptions About Cessation Outcomes Moderate the Effectiveness of a Gain-Framed Smoking Cessation Telephone Counseling Intervention?
Latimer-Cheung AE, Fucito LM, Carlin-Menter S, Rodriguez J, Raymond L, Salovey P, Makuch R, Cummings KM, Toll BA. How Do Perceptions About Cessation Outcomes Moderate the Effectiveness of a Gain-Framed Smoking Cessation Telephone Counseling Intervention? Journal Of Health Communication 2012, 17: 1081-1098. PMID: 22765277, PMCID: PMC3644974, DOI: 10.1080/10810730.2012.665420.Peer-Reviewed Original ResearchCitationsAltmetricMeSH Keywords and ConceptsConceptsState quitlineSmoking cessation counselingTelephone counseling interventionSmoking cessation messagesCessation counselingOutcome expectanciesSmoking statusSmoking cessationCessation messagesQuit statusHealth messagesSecondary analysisSmokers' beliefsCare messagesQuitlineIndividual perceptionsCounseling conditionCounseling interventionPreventionMenPositive outcome expectanciesInterventionOutcomesExpectancyIndividual differences
2010
Preterm birth results in alterations in neural connectivity at age 16 years
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 2010, 54: 2563-2570. PMID: 21073965, PMCID: PMC3020252, DOI: 10.1016/j.neuroimage.2010.11.019.Peer-Reviewed Original ResearchCitationsMeSH Keywords and ConceptsConceptsDiffusion tensor imagingAge 16 yearsPT subjectsBrain injuryLow birth weight preterm childrenTerm controlsUncinate fasciculusBilateral external capsuleFA valuesWeight preterm childrenNeonatal brain injuryLower fractional anisotropy valuesYears of ageBilateral uncinate fasciculusFractional anisotropy valuesRight uncinate fasciculusRight arcuate fasciculusWhite matter disorganizationAlternative neural pathwaysPreterm birthExternal capsuleInferior frontal gyrusPreterm childrenCorpus callosumHigh risk
Academic Achievements and Community Involvement
activity Liver Cancer Prevention
ResearchDetails01/01/2008 - PresentSpain; United KingdomAbstract/SynopsisThis project is an ongoing collaboration in the conduct and analysis of a prospectively randomized controlled clinical trial to prevent/minimize liver disease.
activity Osteoarthritis and Anti-Inflammatory Drugs
ResearchDetails01/01/2008 - PresentJapanAbstract/SynopsisProfessor Makuch conducts research into a systematic review for evaluation of tolerability of nonsteroidal anti-inflammatory drugs in osteoarthritis patients in Japan.
honor Fellow, American Statistical Association
UnknownDetailsUnited Stateshonor Member, Phi Beta Kappa
UnknownDetailsUnited States
Links & Media
News
- December 12, 2022
4 longtime biostatistics professors look back on their years at YSPH
- September 07, 2022
YSPH student’s innovation uses artificial intelligence to improve clinical trials
- July 14, 2021
Yale School of Public Health Partners With Tevogen Bio on Expansion of Regulatory Sciences Program
- April 01, 2016
Drug Safety and Free Speech—Former FDA Chief General Counsel Opens Regulatory Affairs Lecture Series
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