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
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 ResearchConceptsActive 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
1979
Recommendations for the analysis of the effect of treatment on the development of second malignancies
Makuch R, Simon R. Recommendations for the analysis of the effect of treatment on the development of second malignancies. Cancer 1979, 44: 250-253. PMID: 455251, DOI: 10.1002/1097-0142(197907)44:1<250::aid-cncr2820440141>3.0.co;2-1.Peer-Reviewed Original ResearchThymosin 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 VTreatmentcis-Dichlorodiammineplatinum(II) for the treatment of advanced ovarian cancer.
Young R, Von Hoff D, Gormley P, Makuch R, Cassidy J, Howser D, Bull J. cis-Dichlorodiammineplatinum(II) for the treatment of advanced ovarian cancer. Journal Of The National Cancer Institute 1979, 63: 1539-44. PMID: 387224.Peer-Reviewed Original ResearchConceptsCombination chemotherapy studiesAdvanced ovarian cancerSingle-agent activityOverall response rateLife-table analysisOvarian Cancer StudyEvaluable patientsForced diuresisSubstantial nauseaHematologic toxicityChemotherapy studiesRenal toxicityOvarian adenocarcinomaOvarian cancerResponse ratePatientsCancer studiesTreatmentToxicityNauseaVomitingDiuresisAdenocarcinomaMajor roleTherapy