2023
Implementing clinical trial data sharing requires training a new generation of biomedical researchers
Mansmann U, Locher C, Prasser F, Weissgerber T, Sax U, Posch M, Decullier E, Cristea I, Debray T, Held L, Moher D, Ioannidis J, Ross J, Ohmann C, Naudet F. Implementing clinical trial data sharing requires training a new generation of biomedical researchers. Nature Medicine 2023, 29: 298-301. PMID: 36732626, DOI: 10.1038/s41591-022-02080-y.Peer-Reviewed Original Research
2021
Characteristics of available studies and dissemination of research using major clinical data sharing platforms
Vazquez E, Gouraud H, Naudet F, Gross CP, Krumholz HM, Ross JS, Wallach JD. Characteristics of available studies and dissemination of research using major clinical data sharing platforms. Clinical Trials 2021, 18: 657-666. PMID: 34407656, PMCID: PMC8595516, DOI: 10.1177/17407745211038524.Peer-Reviewed Original ResearchConceptsData sharing platformData requestsSharing platformData Repository Information Coordinating CenterOpen accessAccess ProjectStudy metadataProject platformYale Open Data Access ProjectData SpherePlatform characteristicsPlatform websiteRequestsAdditional requestsPlatformWebsitesInformationAccessMetadataAvailable informationRate of disseminationDocumentationProjectDisseminationMetrics
2016
Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis
Ross JS. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis. Systematic Reviews 2016, 5: 159. PMID: 27649796, PMCID: PMC5029013, DOI: 10.1186/s13643-016-0334-1.Commentaries, Editorials and Letters
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
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