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
Optimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada
Egilman AC, Ross JS, Herder M. Optimiser les données accessibles dans le portail de renseignements cliniques de Santé Canada. Canadian Medical Association Journal 2021, 193: e1616-1618. PMID: 34663613, PMCID: PMC8547254, DOI: 10.1503/cmaj.210877-f.Commentaries, Editorials and LettersCharacteristics 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 disseminationDocumentationProjectDisseminationMetricsClinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis
Axson S, Mello MM, Lincow D, Yang C, Gross C, Ross JS, Miller J. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open 2021, 11: e053248. PMID: 34281933, PMCID: PMC8291313, DOI: 10.1136/bmjopen-2021-053248.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsCross-Sectional StudiesDrug ApprovalHumansInformation DisseminationUnited StatesUnited States Food and Drug AdministrationLeveraging Open Science to Accelerate Research
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Leveraging Open Science to Accelerate Research. New England Journal Of Medicine 2021, 384: e61. PMID: 33761227, DOI: 10.1056/nejmp2034518.Commentaries, Editorials and Letters
2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. The BMJ 2020, 371: m3434. PMID: 33028575, PMCID: PMC7537471, DOI: 10.1136/bmj.m3434.Peer-Reviewed Original ResearchConceptsEuropean Medicines AgencyRetrospective cohort studyTherapeutic valueHigh therapeutic valueNew drugsCohort studyLow therapeutic valueEMA approvalUS FoodDrug AdministrationMedicines AgencyFDA approvalDrugsFDARegulatory approvalApproval programsNew medicinesAssociationGreater proportionApprovalProportionAdministrationTime for NIH to lead on data sharing
Sim I, Stebbins M, Bierer BE, Butte AJ, Drazen J, Dzau V, Hernandez AF, Krumholz HM, Lo B, Munos B, Perakslis E, Rockhold F, Ross JS, Terry SF, Yamamoto KR, Zarin DA, Li R. Time for NIH to lead on data sharing. Science 2020, 367: 1308-1309. PMID: 32193313, DOI: 10.1126/science.aba4456.Commentaries, Editorials and LettersUpdating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesHumansHypoglycemic AgentsInformation DisseminationRandomized Controlled Trials as TopicRisk FactorsRosiglitazoneConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatment
2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. The BMJ 2019, 366: l4217. PMID: 31292127, PMCID: PMC6614834, DOI: 10.1136/bmj.l4217.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCross-Sectional StudiesDrug ApprovalDrug IndustryHumansInformation DisseminationPilot ProjectsStakeholder ParticipationTime FactorsConceptsClinical trial dataTrial dataDrug approvalSectional descriptive studyPharmaceutical companiesFDA drug approvalsLarge pharmaceutical companiesClinical trialsDrug levelsNew drug approvalsUS FoodDrug AdministrationNew drug applicationsFDA approvalPatientsNovel drugsDescriptive studyDrug applicationTrialsDrugsExternal investigatorsSharing scoreDrug companiesTrial transparencyStudy measures
2018
Overview and experience of the YODA Project with clinical trial data sharing after 5 years
Ross JS, Waldstreicher J, Bamford S, Berlin JA, Childers K, Desai NR, Gamble G, Gross CP, Kuntz R, Lehman R, Lins P, Morris SA, Ritchie JD, Krumholz HM. Overview and experience of the YODA Project with clinical trial data sharing after 5 years. Scientific Data 2018, 5: 180268. PMID: 30480665, PMCID: PMC6257043, DOI: 10.1038/sdata.2018.268.Peer-Reviewed Original ResearchEarly Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators.
Tannenbaum S, Ross JS, Krumholz HM, Desai NR, Ritchie JD, Lehman R, Gamble GM, Bachand J, Schroter S, Groves T, Gross CP. Early Experiences With Journal Data Sharing Policies: A Survey of Published Clinical Trial Investigators. Annals Of Internal Medicine 2018, 169: 586-588. PMID: 30014127, DOI: 10.7326/m18-0723.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHumansInformation DisseminationPeriodicals as TopicSurveys and QuestionnairesPublication and Dissemination of Results in Clinical Trials of Neurology
Sreekrishnan A, Mampre D, Ormseth C, Miyares L, Leasure A, Ross JS, Sheth KN. Publication and Dissemination of Results in Clinical Trials of Neurology. JAMA Neurology 2018, 75: 890-891. PMID: 29710083, PMCID: PMC6145765, DOI: 10.1001/jamaneurol.2018.0674.Peer-Reviewed Original ResearchClinical Trials as TopicHumansInformation DisseminationNervous System DiseasesNeurologyPublishingRegistriesTime Factors
2017
Data Sharing and Cardiology Platforms and Possibilities
Dey P, Ross JS, Ritchie JD, Desai NR, Bhavnani SP, Krumholz HM. Data Sharing and Cardiology Platforms and Possibilities. Journal Of The American College Of Cardiology 2017, 70: 3018-3025. PMID: 29241491, DOI: 10.1016/j.jacc.2017.10.037.Commentaries, Editorials and LettersMerits of Data Sharing The Digitalis Investigation Group Trial
Angraal S, Ross JS, Dhruva SS, Desai NR, Welsh JW, Krumholz HM. Merits of Data Sharing The Digitalis Investigation Group Trial. Journal Of The American College Of Cardiology 2017, 70: 1825-1827. PMID: 28958337, DOI: 10.1016/j.jacc.2017.07.786.Peer-Reviewed Original ResearchClinical Trials as TopicDigitalis GlycosidesHeart FailureHumansInformation DisseminationPublications
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 LettersBiomedical ResearchClinical Trials as TopicEditorial PoliciesHumansInformation DisseminationPublicationsResearch PersonnelOpen Access Platforms for Sharing Clinical Trial Data
Ross JS, Krumholz HM. Open Access Platforms for Sharing Clinical Trial Data. JAMA 2016, 316: 666-666. PMID: 27532929, DOI: 10.1001/jama.2016.8794.Commentaries, Editorials and LettersAvailability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials
Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials. Journal Of The American Heart Association 2016, 5: e003307. PMID: 27098969, PMCID: PMC4859296, DOI: 10.1161/jaha.116.003307.Peer-Reviewed Original ResearchMeSH KeywordsAccess to InformationCardiotonic AgentsCardiovascular DiseasesDrug IndustryHumansInformation DisseminationRandomized Controlled Trials as TopicConceptsIndividual participant-level dataLarge cardiovascular trialsCardiovascular trialsParticipant-level dataClinical trial dataPharmaceutical companiesMajor pharmaceutical companiesIndustry-sponsored clinical trialsInterventional trialsAvailable trialsClinical trialsTrial dataTrialsPatientsSpecific reasons
2015
US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing
Shaw DL, Ross JS. US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing. The AMA Journal Of Ethic 2015, 17: 1152. PMID: 26698589, DOI: 10.1001/journalofethics.2015.17.12.pfor1-1512.Commentaries, Editorials and Letters
2014
Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature
Stockmann C, Ross JS, Sherwin CMT, Reilly CA, McDowell B, Fassl B, Nkoy F, Maloney CG, Spigarelli MG. Rate of asthma trial outcomes reporting on ClinicalTrials.gov and in the published literature. Journal Of Allergy And Clinical Immunology 2014, 134: 1443-1446. PMID: 25441299, PMCID: PMC4261054, DOI: 10.1016/j.jaci.2014.09.019.Peer-Reviewed Original ResearchPredictors 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