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
Prospective individual matching: covariate balance and power in a comparative study
Makuch R, Zhang Z, Charpentier P, Inouye S. Prospective individual matching: covariate balance and power in a comparative study. Statistics In Medicine 1998, 17: 1517-1526. PMID: 9695196, DOI: 10.1002/(sici)1097-0258(19980715)17:13<1517::aid-sim859>3.0.co;2-0.Peer-Reviewed Original Research
1996
Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation
Horwitz R, Singer B, Makuch R, Viscoli C. Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. Journal Of Clinical Epidemiology 1996, 49: 395-400. PMID: 8621989, DOI: 10.1016/0895-4356(95)00058-5.Peer-Reviewed Original ResearchConceptsClinical inquiryBeta-Blocker Heart Attack TrialCoronary artery surgeryHeart Attack TrialSubgroup of patientsArtery surgeryAspirin useCoronary surgeryMulticenter RCTClinical featuresAttack TrialClinical centersClinical conditionsTreatment groupsPatientsBenefit of propranololClinical decisionTrial resultsHeterogeneous groupPropranololRCTsSurgeryTreatmentTrialsOverall benefit
1990
A Phase 1 Study of Ribavirin in Human Immunodeficiency Virus-Infected Patients
Roberts R, Jurica K, Meyer W, Paxton H, Makuch R. A Phase 1 Study of Ribavirin in Human Immunodeficiency Virus-Infected Patients. The Journal Of Infectious Diseases 1990, 162: 638-642. PMID: 2117625, DOI: 10.1093/infdis/162.3.638.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsPhase 1 studyDaily dosesAdverse reactionsTreatment groupsHuman immunodeficiency virus-infected patientsPatients' peripheral blood mononuclear cellsHIV surrogate markersT lymphocyte subsetsVirus-infected patientsClinical adverse reactionsAnti-HIV effectDemonstrable beneficial effectsHuman immunodeficiency virusBlood mononuclear cellsOral ribavirinP24 antigenemiaLymphocyte subsetsTotal lymphocytesSerum betaImmunodeficiency virusLymphocyte markersMononuclear cellsLymphocyte populationsSurrogate markerA 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
1984
Second malignant neoplasms complicating Hodgkin's disease: the National Cancer Institute experience.
Tester W, Kinsella T, Waller B, Makuch R, Kelley P, Glatstein E, DeVita V. Second malignant neoplasms complicating Hodgkin's disease: the National Cancer Institute experience. Journal Of Clinical Oncology 1984, 2: 762-9. PMID: 6547479, DOI: 10.1200/jco.1984.2.7.762.Peer-Reviewed Original ResearchConceptsSecond malignant neoplasmsHodgkin's diseaseMalignant neoplasmsSolid tumorsNational Cancer Institute ExperienceChronic myeloid leukemiaCases of sarcomaRisk of leukemiaUntreated patientsPatient ageHodgkin's lymphomaMedical recordsInstitute experienceMyeloid leukemiaSimilar riskAge 40Treatment groupsPatientsGreater riskLeukemiaTen yearsDiseaseTumorsLymphomaPositive association
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
Influence of prognostic factors on survival in Ewing's sarcoma.
Glaubiger D, Makuch R, Schwarz J. Influence of prognostic factors on survival in Ewing's sarcoma. National Cancer Institute Monograph 1981, 285-8. PMID: 7300894.Peer-Reviewed Original ResearchConceptsPrimary diseaseEwing's sarcomaTreatment groupsSerum lactate dehydrogenase levelIntensive adjuvant chemotherapySystemic chemotherapy regimensLactate dehydrogenase levelsNumber of patientsSignificant differencesNational Cancer InstituteRecent treatment regimensAdjuvant chemotherapyChemotherapy regimensPrognostic factorsPrimary lesionTreatment regimensLDH levelsMetastatic statusSurvival resultsDehydrogenase levelsTreatment protocolLocal irradiationCancer InstituteSarcomaPrimary site
1980
Determination of prognostic factors and their influence on therapeutic results in patients with Ewing's sarcoma
Glaubiger D, Makuch R, Schwarz J, Levine A, Johnson R. Determination of prognostic factors and their influence on therapeutic results in patients with Ewing's sarcoma. Cancer 1980, 45: 2213-2219. PMID: 7370962, DOI: 10.1002/1097-0142(19800415)45:8<2213::aid-cncr2820450834>3.0.co;2-l.Peer-Reviewed Original ResearchConceptsDisease-free survivalPrognostic factorsEwing's sarcomaTreatment groupsLactic acid dehydrogenasePrimary diseaseSerum lactic acid dehydrogenaseSystemic chemotherapy regimensFavorable prognostic factorTime of presentationLactic acid dehydrogenase levelsNumber of patientsResults of treatmentNational Cancer InstituteLatest regimensChemotherapy regimensMetastatic diseaseFavorable prognosisMetastatic statusFavorable outcomeTherapeutic resultsDehydrogenase levelsTreatment protocolLocal irradiationCancer Institute
1979
Thymosin Fraction V and Intensive Combination Chemotherapy: Prolonging the Survival of Patients With Small-Cell Lung Cancer
Cohen M, Chretien P, Ihde D, Fossieck B, Makuch R, Bunn P, Johnston A, Shackney S, Matthews M, Lipson S, Kenady D, Minna J. Thymosin Fraction V and Intensive Combination Chemotherapy: Prolonging the Survival of Patients With Small-Cell Lung Cancer. JAMA 1979, 241: 1813-1815. DOI: 10.1001/jama.1979.03290430031019.Peer-Reviewed Original ResearchThymosin fraction VIntensive remission induction chemotherapySmall cell bronchogenic carcinomaSmall cell lung cancerComplete response rateRemission induction chemotherapyWeeks of chemotherapyIntensive combination chemotherapySurvival of patientsRelapse-free survivalThymosin administrationThymosin treatmentComplete respondersCombination chemotherapyBronchogenic carcinomaImmune deficitsLung cancerSurvival durationSurvival timeTreatment groupsResponse rateChemotherapyPatientsFraction VTreatmentThymosin fraction V and intensive combination chemotherapy. Prolonging the survival of patients with small-cell lung cancer.
Cohen M, Chretien P, Ihde D, Fossieck B, Makuch R, Bunn P, Johnston A, Shackney S, Matthews M, Lipson S, Kenady D, Minna J. Thymosin fraction V and intensive combination chemotherapy. Prolonging the survival of patients with small-cell lung cancer. JAMA 1979, 241: 1813-5. PMID: 219267, DOI: 10.1001/jama.241.17.1813.Peer-Reviewed Original ResearchConceptsThymosin fraction VIntensive remission induction chemotherapySmall cell bronchogenic carcinomaSmall cell lung cancerComplete response rateRemission induction chemotherapyWeeks of chemotherapyIntensive combination chemotherapySurvival of patientsRelapse-free survivalThymosin administrationThymosin treatmentComplete respondersCombination chemotherapyBronchogenic carcinomaImmune deficitsLung cancerSurvival durationSurvival timeTreatment groupsResponse rateChemotherapyPatientsFraction VTreatment