2020
Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
Talebi R, Redberg RF, Ross JS. Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA. Trials 2020, 21: 675. PMID: 32703252, PMCID: PMC7376878, DOI: 10.1186/s13063-020-04603-9.Peer-Reviewed Original Research
2019
Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study
Strom JB, Tamez H, Zhao Y, Valsdottir LR, Curtis J, Brennan JM, Shen C, Popma JJ, Mauri L, Yeh RW. Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. American Heart Journal 2019, 212: 64-71. PMID: 30953936, PMCID: PMC6535119, DOI: 10.1016/j.ahj.2019.02.007.Peer-Reviewed Original ResearchConceptsMedical therapyDual Antiplatelet Therapy StudyEnd pointEnd-point eventsClinical trial programEfficacy of therapyPatient-level dataClinical trial dataHealth system dataUse of registriesNew medical treatmentsProcedural registryRandomized trialsClaims databasePatient populationNational registryAdministrative claimsOutcome dataMedical treatmentTrial programTrial dataRegistryTrial informationTherapy studiesTrial results
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
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