2022
Consistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy design
2021
Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation
Benning TJ, Shah ND, Inselman JW, Van Houten HK, Ross JS, Wyatt KD. Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation. Clinical Trials 2021, 18: 732-740. PMID: 34269090, PMCID: PMC10119689, DOI: 10.1177/17407745211030683.Peer-Reviewed Original ResearchConceptsPediatric Research Equity ActClinical trialsBest PharmaceuticalsOncology drugsDrug utilizationPediatric indicationsLabel changesPediatric-specific evidenceAdministrative claims databasePediatric Hematology/OncologyQuality of evidenceDrug labelling changesHematology/oncologyDrug utilization ratesNew pediatric indicationsLow methodological rigorClaims databaseComparator groupPediatric utilizationTrial characteristicsBACKGROUND/Pediatric useMonthly utilization ratesDrug safetyStudy design
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 ratesAge of Data at the Time of Publication of Contemporary Clinical Trials
Welsh J, Lu Y, Dhruva SS, Bikdeli B, Desai NR, Benchetrit L, Zimmerman CO, Mu L, Ross JS, Krumholz HM. Age of Data at the Time of Publication of Contemporary Clinical Trials. JAMA Network Open 2018, 1: e181065-e181065. PMID: 30646100, PMCID: PMC6324269, DOI: 10.1001/jamanetworkopen.2018.1065.Peer-Reviewed Original ResearchConceptsClinical trialsFinal data collectionParticipant enrollmentInternal medicineMultivariable linear regression analysisFirst participant enrollmentPrimary end pointMultivariable regression analysisContemporary clinical trialsClinical trial dataJAMA Internal MedicineRegression analysisCross-sectional analysisTime of publicationMedian timeTrial characteristicsOutcome measuresMAIN OUTCOMENew England JournalClinical practiceLinear regression analysisTrial dataEnd pointTrial resultsTrials
2016
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials
2014
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS. Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 2014, 15: 384. PMID: 25277128, PMCID: PMC4192345, DOI: 10.1186/1745-6215-15-384.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationAgedAttitude of Health PersonnelChi-Square DistributionClinical Trials as TopicCooperative BehaviorCross-Sectional StudiesDatabases, FactualFemaleHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationInternetMaleMiddle AgedPerceptionRegistriesResearch PersonnelSurveys and QuestionnairesConceptsTrial funding sourceExact testMain outcome measuresFisher's exact testCross-sectional surveyChi-square testClinical trialsTrial characteristicsOutcome measuresGeneral medical journalsClinical trialistsWeb-based surveyTrialistsExploratory analysisBackgroundA numberStatistical significanceSignificant differencesExternal investigatorsClinical trial data sharingTrialsMedical journalsPharmaceutical companiesFunding sourcesIndustry fundingPotential respondents