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
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
Evaluation of Therapeutic Strategies: A New Method for Balancing Risk and Benefit
Troche C, Paltiel A, Makuch R. Evaluation of Therapeutic Strategies: A New Method for Balancing Risk and Benefit. Value In Health 2000, 3: 12-22. PMID: 16464177, DOI: 10.1046/j.1524-4733.2000.31002.x.Peer-Reviewed Original ResearchPatient preferencesDose-related efficacyPatients' subjective assessmentPatient-specific preferencesSpecific therapeutic interventionsClinical trial informationEfficacy-toxicity tradeDose prescribedSafety profileTherapeutic alternativeAcceptable efficacyDose intervalSubjective assessmentTherapeutic strategiesTherapeutic interventionsDrug efficacyDifferent patientsTrial informationDifferent drugsDose rangeEfficacyDifferent efficacyDrugsPatientsBalancing Risks
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
1981
Association 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 assaysDrugsAssaysAssociationChemotherapy