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
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
A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients
Messerschmidt G, Makuch R, Appelbaum F, Ungerleider R, Abrams R, O'Donnell J, Holohan T, Fontana J, Wright D, Anagnou N, Shan T, Chesbro B, Deisseroth A. A prospective randomized trial of HLA‐matched versus mismatched single‐donor platelet transfusions in cancer patients. Cancer 1988, 62: 795-801. PMID: 3293762, DOI: 10.1002/1097-0142(19880815)62:4<795::aid-cncr2820620426>3.0.co;2-7.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAmbulatory CareAntibody FormationBlood DonorsBlood PlateletsBlood TransfusionChildChild, PreschoolClinical Trials as TopicFemaleHemorrhageHistocompatibility TestingHumansInfantMaleMiddle AgedNeoplasmsPlatelet TransfusionProspective StudiesRandom AllocationThrombocytopeniaTransfusion ReactionConceptsSingle-donor platelet transfusionsPlatelet transfusionsCancer patientsFebrile patientsPosttransfusion incrementsThrombocytopenic cancer patientsTransfusion of HLASevere bleeding episodesMulti-institution trialNonfebrile patientsIntensive chemotherapyBleeding episodesAntiplatelet antibodiesAntibody titersSignificant thrombocytopeniaHistocompatability antigensTransfusionPatientsMismatched groupHLAThrombocytopeniaPlateletsEpisodesSeparate episodesTrialsStatistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies
Makuch R, Parks W. Statistical Methods for the Analysis of HIV-1 Core Polypeptide Antigen Data in Clinical Studies. AIDS Research And Human Retroviruses 1988, 4: 305-316. PMID: 3061416, DOI: 10.1089/aid.1988.4.305.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsInitiation of therapyPlacebo-controlled studyHIV-1 antigensDemonstrated clinical efficacyHIV-1 coreAntiretroviral effectClinical efficacyAIDS patientsAntiretroviral activityClinical studiesLymphocyte culturesVirus expressionSerum dataAntigen dataPatientsSurvival analysis methodsLaboratory dataAZTGroup differencesMost laboratory dataCulture dataStatistical methodsSignificant declineSerum
1986
Pulmonary toxicity with combined modality therapy for limited stage small-cell lung cancer.
Brooks B, Seifter E, Walsh T, Lichter A, Bunn P, Zabell A, Johnston-Early A, Edison M, Makuch R, Cohen M. Pulmonary toxicity with combined modality therapy for limited stage small-cell lung cancer. Journal Of Clinical Oncology 1986, 4: 200-9. PMID: 3003259, DOI: 10.1200/jco.1986.4.2.200.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Small CellCombined Modality TherapyCyclophosphamideDoxorubicinFemaleHumansLomustineLung NeoplasmsMaleMethotrexateMiddle AgedProcarbazinePrognosisProspective StudiesPulmonary FibrosisRadiographyRandom AllocationRespiratory Function TestsVincristineConceptsPulmonary function testsLimited stage small cell lung cancerStage small cell lung cancerSmall cell lung cancerModality therapyPulmonary toxicityPulmonary complicationsVital capacityLung cancerRadiation therapyLife-threatening pulmonary toxicityInitial pulmonary function testLower vital capacitySubsequent pulmonary complicationsBilateral pulmonary infiltratesDisease-free survivalModality armPulmonary infiltratesPulmonary morbidityExpiratory volumeOverall survivalPerformance statusProspective trialClinical courseHospital admission
1985
The role of radiation therapy in the treatment of small cell lung cancer
Lichter A, Bunn P, Ihde D, Cohen M, Makuch R, Carney D, Johnston‐Early A, Minna J, Glatstein E. The role of radiation therapy in the treatment of small cell lung cancer. Cancer 1985, 55: 2163-2175. PMID: 2983875, DOI: 10.1002/1097-0142(19850501)55:9+<2163::aid-cncr2820551420>3.0.co;2-y.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarcinoma, Small CellClinical Trials as TopicCombined Modality TherapyCyclophosphamideDoxorubicinFollow-Up StudiesHumansLomustineLung NeoplasmsMethotrexateProcarbazineProspective StudiesRadiotherapyRadiotherapy DosageRandom AllocationTime FactorsVincristineWhole-Body IrradiationConceptsSmall cell lung cancerLimited-stage small cell lung cancerProphylactic cranial irradiationCell lung cancerCranial irradiationThoracic irradiationLung cancerExtensive-stage small-cell lung cancerComplete response statusLimited-stage diseaseOptimal treatment approachCombination of chemotherapyMinimum of toxicityLong-term survivalSystemic irradiationSystemic chemotherapyAggressive therapyPartial responseCNS failureResponse statusTreatment protocolOngoing protocolRadiation therapyTreatment approachesPatients
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 improvement