2023
Temporal Trends in Gender of Principal Investigators and Patients in Cardiovascular Clinical Trials
Yong C, Suvarna A, Harrington R, Gummidipundi S, Krumholz H, Mehran R, Heidenreich P. Temporal Trends in Gender of Principal Investigators and Patients in Cardiovascular Clinical Trials. Journal Of The American College Of Cardiology 2023, 81: 428-430. PMID: 36697143, DOI: 10.1016/j.jacc.2022.10.038.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
2017
How well does early-career investigators' cardiovascular outcomes research training align with funded outcomes research?
Crowley MJ, Al-Khatib SM, Wang TY, Khazanie P, Kressin NR, Krumholz HM, Kiefe CI, Wells BL, O'Brien SM, Peterson ED, Sanders GD. How well does early-career investigators' cardiovascular outcomes research training align with funded outcomes research? American Heart Journal 2017, 196: 163-169. PMID: 29421009, DOI: 10.1016/j.ahj.2017.09.008.Peer-Reviewed Original ResearchConceptsOutcomes researchEarly career investigatorsCardiovascular Outcomes ResearchFunded grantsCost-effectiveness researchBlood InstituteNational HeartClinical epidemiologySystematic reviewPrior trainingCommunity-engaged researchResearch training programsDissemination researchInvestigator trainingCompetency areasObservational researchCore competency areasInvestigators' interestOutcomes researchersInvestigatorsTraining programHealth informaticsSimilar resultsLungEpidemiology
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
2005
Symposium Presentations
Mendelsohn M, Balke C, Bonow R, Fuster V, Grant A, Mark D, Peterson E, Antman E, Krumholz H, Balaban R, Prystowsky E, Ferguson J, Al-Sheikh T, Berk B, Vatner S, Zipes D, Holmes D, Seidman C, Nabel E, Zoghbi W. Symposium Presentations. Journal Of The American College Of Cardiology 2005, 46: a5-a70. PMID: 16182079, DOI: 10.1016/j.jacc.2005.06.020.Peer-Reviewed Original Research