2023
Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies
Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.Peer-Reviewed Original ResearchStudies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity
Kumar A, Ross J, Patel N, Rathi V, Redberg R, Dhruva S. Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity. Health Affairs 2023, 42: 1559-1567. PMID: 37931187, DOI: 10.1377/hlthaff.2023.00384.Peer-Reviewed Original ResearchConceptsPrescription digital therapeuticDigital therapeuticsClinical studiesRetrospective cross-sectional analysisCross-sectional analysisStrong evidence baseHalf of studiesUpper age limitPremarket studiesDrug AdministrationClinician's prescriptionClinical useClinical researchEvidence baseTherapeuticsOne-thirdEvidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov
Rivero-de-Aguilar A, Pérez-Ríos M, Ruano-Raviña A, Candal-Pedreira C, Puente-Hernandez M, Ross J, Varela-Lema L. Evidence of publication bias in multiple sclerosis clinical trials: a comparative analysis of published and unpublished studies registered in ClinicalTrials.gov. Journal Of Neurology Neurosurgery & Psychiatry 2023, 94: 597-604. PMID: 36977551, DOI: 10.1136/jnnp-2023-331132.Peer-Reviewed Original ResearchConceptsClinical trialsPeer-reviewed journalsTrial publicationsPublication biasMultivariate logistic regression analysisMultiple sclerosis clinical trialsFavorable primary outcomeMS clinical researchPhase IIILogistic regression analysisMultiple sclerosis drugsCase-control designTreatment tolerabilityMore patientsPrimary outcomeUnpublished trialsMS drugsTreatment decisionsLower oddsStudy design characteristicsMultivariate analysisClinical researchUnpublished studiesTrialsGoogle Scholar
2021
Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs
Miller JE, Mello MM, Wallach JD, Gudbranson EM, Bohlig B, Ross JS, Gross CP, Bach PB. Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA Network Open 2021, 4: e217075. PMID: 33950209, PMCID: PMC8100865, DOI: 10.1001/jamanetworkopen.2021.7075.Peer-Reviewed Original ResearchConceptsFDA approvalHigh-income countriesDrug approvalIncome countriesNovel drugsDrug Administration (FDA) drug approvalsRegulatory agency websitesCross-sectional analysisProportion of drugPrimary outcomeFDA drug approvalsProportion of countriesDrug trialsMAIN OUTCOMEUS FoodClinical researchCountry income levelLow-income countriesMarketing approvalTrialsGoogle ScholarDrugsDrug companiesApprovalMedian
2019
Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke Database
2016
Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
2015
Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices Evidence And Research 2015, Volume 8: 241-249. PMID: 26060416, PMCID: PMC4454210, DOI: 10.2147/mder.s82964.Peer-Reviewed Original Research
2014
High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities
Wang EA, Aminawung JA, Wildeman C, Ross JS, Krumholz HM. High Incarceration Rates Among Black Men Enrolled In Clinical Studies May Compromise Ability To Identify Disparities. Health Affairs 2014, 33: 848-855. PMID: 24799583, PMCID: PMC4065793, DOI: 10.1377/hlthaff.2013.1325.Peer-Reviewed Original ResearchConceptsClinical studiesHealth outcomesBlack menProspective clinical studyObservational clinical researchBlood InstituteNational HeartClinical researchWhite womenRacial disparitiesWhite menMinimal riskMenBlack womenHigh rateJail inmatesMinority populationsWomenOutcomesEffects of incarcerationImpact of incarcerationHigh incarceration ratesIncarcerationLungFollow