2006
Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations
Wu Y, Makuch R. Detecting Rare Adverse Events in Postmarketing Studies: Sample Size Considerations. Therapeutic Innovation & Regulatory Science 2006, 40: 89-98. DOI: 10.1177/009286150604000111.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
2003
Systematic review of NSAID-induced adverse reactions in patients with rheumatoid arthritis in Japan
Tomita T, Ochi T, Sugano K, Uemura S, Makuch R. Systematic review of NSAID-induced adverse reactions in patients with rheumatoid arthritis in Japan. Modern Rheumatology 2003, 13: 143-152. DOI: 10.1007/s10165-002-0214-5.Peer-Reviewed Original ResearchNonsteroidal antiinflammatory drugsProportion of patientsAdverse reactionsSystematic reviewGastrointestinal adverse reactionsRheumatoid arthritis patientsFixed-effects modelRA patientsArthritis patientsRheumatoid arthritisMost withdrawalsClinical trialsAntiinflammatory drugsPatientsTrialsDrugsRiskTotalEvent analysisArthritisReviewIncidenceProportionAdministrationEndpoint
2000
Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Bensen W, Zhao S, Burke T, Zabinski R, Makuch R, Maurath C, Agrawal N, Geis G. Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo. The Journal Of Rheumatology 2000, 27: 1876-83. PMID: 10955327.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsCyclooxygenase InhibitorsDigestive SystemDouble-Blind MethodDyspepsiaFemaleHumansIsoenzymesMaleMembrane ProteinsMiddle AgedNaproxenNauseaOsteoarthritisProspective StudiesProstaglandin-Endoperoxide SynthasesPyrazolesRisk FactorsSulfonamidesTime FactorsTreatment OutcomeConceptsUpper gastrointestinal tolerabilityUpper GI symptomsSevere abdominal painComposite endpointAbdominal painGastrointestinal tolerabilityGI symptomsIndependent predictorsRheumatoid arthritisRelative riskCOX-2-specific inhibitorsUpper GI tolerabilityTreatment group patientsDose-response relationshipGI tolerabilityPlacebo patientsGroup patientsCumulative incidenceParallel groupClinical trialsPlaceboPatientsCelecoxibTolerabilityEndpoint
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
Verapamil use in patients with cardiovascular disease: An overview of randomized trials
Pepine C, Faich G, Makuch R. Verapamil use in patients with cardiovascular disease: An overview of randomized trials. Clinical Cardiology 1998, 21: 633-641. PMID: 9755379, PMCID: PMC6655547, DOI: 10.1002/clc.4960210906.Peer-Reviewed Original ResearchConceptsMyocardial infarctionVerapamil useNonfatal reinfarctionCalcium antagonistsDecreased riskDrug classesCardiovascular diseaseCertain calcium antagonistsNonfatal myocardial infarctionOutcome of deathParallel-group studyStandard meta-analytic techniquesRandomized clinical trialsAcute myocardial infarctionEnglish-language articlesEvidence of harmAngina StudyHypertensive patientsOverall mortalityRandomized studyRandomized trialsTrial characteristicsClinical trialsPatient outcomesMEDLINE search
1990
Ten-year survival of patients with small-cell lung cancer treated with combination chemotherapy with or without irradiation.
Johnson B, Grayson J, Makuch R, Linnoila R, Anderson M, Cohen M, Glatstein E, Minna J, Ihde D. Ten-year survival of patients with small-cell lung cancer treated with combination chemotherapy with or without irradiation. Journal Of Clinical Oncology 1990, 8: 396-401. PMID: 2155310, DOI: 10.1200/jco.1990.8.3.396.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerLung cancerLung cancer 2Initiation of chemotherapyTen-year survivalCell lung cancerTherapeutic clinical trialsCranial irradiationCombination chemotherapyOriginal malignancySecond cancersClinical trialsHigh riskPatientsCancer 2CancerChemotherapyMalignancyMore yearsCauseYearsChestDiagnosisTrialsA multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy
Roberts R, Hollinger F, Parks W, Rasheed S, Laurence J, Heseltine P, Makuch R, Lubina J, Johnson K, Group R. A multicenter clinical trial of oral ribavirin in HIV-infected people with lymphadenopathy. AIDS 1990, 4: 67-72. PMID: 1690551, DOI: 10.1097/00002030-199001000-00009.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAIDS-Related ComplexDouble-Blind MethodFemaleGene Products, gagHIVHIV AntigensHIV Core Protein p24HIV InfectionsHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesRNA-Directed DNA PolymeraseUnited StatesViral Core ProteinsConceptsOral ribavirinPeripheral blood mononuclear cellsPlacebo-controlled trialBlood mononuclear cellsMulticenter clinical trialHIV isolationP24 antigenemiaStudy drugMulticenter trialActive treatmentDaily dosesMononuclear cellsClinical trialsMedical CenterWeek 6HIV activityAdult menRibavirinTrialsLymphadenopathyHIVInterlaboratory variationCritical roleAntigenemiaPlaceboA multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.
Roberts R, Dickinson G, Heseltine P, Leedom J, Mansell P, Rodriguez S, Johnson K, Lubina J, Makuch R. A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group. JAIDS Journal Of Acquired Immune Deficiency Syndromes 1990, 3: 884-92. PMID: 1974628.Peer-Reviewed Original ResearchMeSH KeywordsAcquired Immunodeficiency SyndromeAdministration, OralAdolescentAdultCD4 AntigensCD4-Positive T-LymphocytesDose-Response Relationship, DrugDouble-Blind MethodEvaluation Studies as TopicHumansImmunoblastic LymphadenopathyLeukocyte CountMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRibavirinRibonucleosidesConceptsOral ribavirinActive treatmentBaseline CD4 cell countMajor protocol violationsCD4 cell countPlacebo-controlled trialMulticenter clinical trialSignificant differencesPlacebo patientsPlacebo groupPlacebo treatmentStudy entryTreat analysisWashout periodDaily dosesClinical trialsKaposi's sarcomaProtocol violationsMedical CenterTreatment superiorityTreatment groupsPlaceboRibavirinPatientsOverall significant difference
1982
Sample size requirements for comparing time-to-failure among k treatment groups
Makuch R, Simon R. Sample size requirements for comparing time-to-failure among k treatment groups. Journal Of Clinical Epidemiology 1982, 35: 861-867. PMID: 7142364, DOI: 10.1016/0021-9681(82)90051-0.Peer-Reviewed Original Research
1981
Adjuvant Immunotherapy or Chemotherapy for Malignant Melanoma: Preliminary Report of the National Cancer Institute Randomized Clinical Trial
Fisher R, Terry W, Hodes R, Rosenberg S, Makuch R, Gordon H, Fisher S. Adjuvant Immunotherapy or Chemotherapy for Malignant Melanoma: Preliminary Report of the National Cancer Institute Randomized Clinical Trial. Surgical Clinics Of North America 1981, 61: 1267-1277. PMID: 7031934, DOI: 10.1016/s0039-6109(16)42582-x.Peer-Reviewed Original ResearchConceptsBacille Calmette-GuerinDisease-free intervalAdjuvant immunotherapyClinical trialsMalignant melanomaStage I malignant melanomaStage II melanomaSurvival of patientsNational Cancer InstituteOverall survivalPostsurgical patientsMethyl-CCNUCalmette-GuerinCancer InstituteMelanoma cellsMelanomaFurther treatmentPreliminary reportImmunotherapyChemotherapyPatientsTrialsSurvivalSignificant improvementAssociation between human tumor colony-forming assay results and response of an individual patient's tumor to chemotherapy
Von Hoff D, Casper J, Bradley E, Sandbach J, Jones D, Makuch R. Association between human tumor colony-forming assay results and response of an individual patient's tumor to chemotherapy. The American Journal Of Medicine 1981, 70: 1027-1032. PMID: 7234870, DOI: 10.1016/0002-9343(81)90859-7.Peer-Reviewed Original ResearchConceptsIndividual patient's tumorPatient tumorsHuman tumorsGeneral oncology patientsParticular patient's tumorSeparate histologic typesProspective clinical trialsDrug sensitivity assaysColony-forming assaysHistologic typeOncology patientsClinical trialsPatient responsePatientsRetrospective mannerTumorsAntineoplastic agentsFluid specimenEnough cellsVivo resultsSensitivity assaysDrugsAssaysAssociationChemotherapyLaboratory parameters as an alternative to performance status in prognostic stratification of patients with small cell lung cancer.
Cohen M, Makuch R, Johnston-Early A, Ihde D, Bunn P, Fossieck B, Minna J. Laboratory parameters as an alternative to performance status in prognostic stratification of patients with small cell lung cancer. Journal Of The National Cancer Institute 1981, 65: 187-95. PMID: 6263468.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerCell lung cancerLaboratory parametersLung cancerPerformance statusPrognostic factorsPrognostic indexSmall cell anaplastic lung cancerInfluential prognostic factorObjective prognostic indexPretreatment performance statusMajor prognostic factorSelf-limited eventAlpha-1 globulinCancer clinical trialsLaboratory resultsSignificant prognosticatorMedian followupAlbumin levelsMinimum followupPrognostic stratificationSurvival durationClinical trialsHigher hemoglobinTreatment response