2010
Sample size for post‐marketing safety studies based on historical controls
Wu Y, Makuch RW. Sample size for post‐marketing safety studies based on historical controls. Pharmacoepidemiology And Drug Safety 2010, 19: 869-875. PMID: 20572025, DOI: 10.1002/pds.1990.Peer-Reviewed Original Research
2005
Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia
Woods SW, Gueorguieva RV, Baker CB, Makuch RW. Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia. JAMA Psychiatry 2005, 62: 961-970. PMID: 16143728, DOI: 10.1001/archpsyc.62.9.961.Peer-Reviewed Original ResearchMeSH KeywordsAge FactorsAntipsychotic AgentsBrief Psychiatric Rating ScaleDouble-Blind MethodDrug Administration ScheduleFemaleHumansMalePlacebosPsychotic DisordersRandomized Controlled Trials as TopicResearch DesignSchizophreniaSchizophrenic PsychologySelection BiasSeverity of Illness IndexSex FactorsTreatment OutcomeConceptsBrief Psychiatric Rating ScalePlacebo-controlled trialPsychiatric Rating ScalePlacebo-controlled studyAtypical antipsychotic medicationsDose-controlled studyMedication trialsAntipsychotic medicationRating ScaleDouble-blind clinical trialNew atypical antipsychotic medicationsDose-controlled trialsTreatment completion ratesPlacebo control groupEnd point changePercentage of menDrug Administration databaseRandom effects analysisIll adultsMedication armClinical trialsNew medicationsNovel medicationsSame drugAverage age
1999
Stratified Randomization for Clinical Trials
Kernan W, Viscoli C, Makuch R, Brass L, Horwitz R. Stratified Randomization for Clinical Trials. Journal Of Clinical Epidemiology 1999, 52: 19-26. PMID: 9973070, DOI: 10.1016/s0895-4356(98)00138-3.Peer-Reviewed Original ResearchConceptsStratified randomizationSmall trialsInterim analysisActive-control equivalence trialsClinical factorsLarge trialsSuperiority trialSubgroup analysisClinical trialsTreatment responsivenessTreatment outcomesMEDLINE searchTreatment groupsStratification factorsEquivalence trialPrognosisTrialsRandomizationType ITheoretical benefitsImportance of stratificationStratificationSample sizeInvestigatorsPatients
1998
Portal hypertension and variceal bleeding: An AASLD single topic symposium
Grace N, Groszmann R, Garcia‐Tsao G, Burroughs A, Pagliaro L, Makuch R, Bosch J, Stiegmann G, Henderson J, de Franchis R, Wagner J, Conn H, Rodes J. Portal hypertension and variceal bleeding: An AASLD single topic symposium. Hepatology 1998, 28: 868-880. PMID: 9731585, DOI: 10.1002/hep.510280339.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsClinical versus Statistical Considerations in the Design and Analysis of Clinical Research
Horwitz R, Singer B, Makuch R, Viscoli C. Clinical versus Statistical Considerations in the Design and Analysis of Clinical Research. Journal Of Clinical Epidemiology 1998, 51: 305-307. PMID: 9539886, DOI: 10.1016/s0895-4356(98)00006-7.Peer-Reviewed Original Research
1989
Issues in planning and interpreting active control equivalence studies
Makuch R, Johnson M. Issues in planning and interpreting active control equivalence studies. Journal Of Clinical Epidemiology 1989, 42: 503-511. PMID: 2661729, DOI: 10.1016/0895-4356(89)90146-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAspirinCerebrovascular DisordersClinical Trials as TopicHumansRandom AllocationResearch DesignSulfinpyrazoneTiclopidineConceptsActive control equivalence studiesEquivalence studyActive-control equivalence trialsPrevention of strokeNew drugsActive control drugActive control treatmentAlternative study designsCurrent therapiesPlaceboControl drugTherapeutic equivalenceEquivalence trialNew treatmentsMethodologic issuesDrug efficacyStudy designTreatment controlDrugsEfficacyEquivalence designTrialsTreatmentStudy validation
1988
Identifying prognostic factors in binary outcome data: An application using liver function tests and age to predict liver metastases
Makuch R, Rosenberg P, Mulshine J. Identifying prognostic factors in binary outcome data: An application using liver function tests and age to predict liver metastases. Statistics In Medicine 1988, 7: 843-856. PMID: 2842852, DOI: 10.1002/sim.4780070803.Peer-Reviewed Original ResearchConceptsLiver function testsLiver metastasesFunction testsOutcome dataSmall cell lung cancerImportant prognostic variablesCell lung cancerLogistic regression modelsPrognostic factorsLung cancerPrognostic variablesMetastasisBinary outcome dataSpecific guidelinesRegression modelsAgeStandard logistic regression model