2022
Population-Level Strategies for Nirmatrelvir/Ritonavir Prescribing—A Cost-effectiveness Analysis
Savinkina A, Paltiel A, Ross J, Gonsalves G. Population-Level Strategies for Nirmatrelvir/Ritonavir Prescribing—A Cost-effectiveness Analysis. Open Forum Infectious Diseases 2022, 9: ofac637. PMID: 36589482, PMCID: PMC9792084, DOI: 10.1093/ofid/ofac637.Peer-Reviewed Original ResearchCost-effectiveness analysisTrade-offs implicitSevere diseaseDecision analytic modelAllocation decisionsPay thresholdsPolicy strategiesUnvaccinated patientsVaccination statusHigh riskTreatment effectivenessHigh-risk individualsAllocation strategyPopulation-level strategiesWillingnessFurther priorityDrug costsSensitivity analysisCostRitonavir treatmentUnvaccinated personsVaccinated adultsPatient populationClinical trialsLower risk
2019
Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies
Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. Journal Of General Internal Medicine 2019, 34: 2319-2321. PMID: 31313117, PMCID: PMC6848610, DOI: 10.1007/s11606-019-05149-6.Peer-Reviewed Original Research
2018
Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
Gopal AD, Wallach JD, Aminawung JA, Gonsalves G, Dal-Ré R, Miller JE, Ross JS. Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals. Trials 2018, 19: 448. PMID: 30134950, PMCID: PMC6106722, DOI: 10.1186/s13063-018-2825-y.Peer-Reviewed Original ResearchConceptsPrimary outcome dataOutcome dataCross-sectional analysisUnregistered trialsTrial characteristicsClinical trialsFavorable findingsProfessional medical societiesMedical societiesIndustry-funded trialsFrequency of registrationPrimary outcomeRegistered trialsEnrollment siteProspective fashionChi-square analysisProportion of trialsOriginal research reportsInitial ascertainmentTrialsHigh-impact journalsMedical Journal EditorsRegistration timingRetrospective registrationLower ratesComparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDisease
2017
Research, regulatory, and clinical decision-making: the importance of scientific integrity
Wallach JD, Gonsalves GS, Ross JS. Research, regulatory, and clinical decision-making: the importance of scientific integrity. Journal Of Clinical Epidemiology 2017, 93: 88-93. PMID: 29042327, DOI: 10.1016/j.jclinepi.2017.08.021.Commentaries, Editorials and Letters