2024
Artificial Intelligence in Cardiovascular Clinical Trials
Cunningham J, Abraham W, Bhatt A, Dunn J, Felker G, Jain S, Lindsell C, Mace M, Martyn T, Shah R, Tison G, Fakhouri T, Psotka M, Krumholz H, Fiuzat M, O’Connor C, Solomon S, Collaboratory H. Artificial Intelligence in Cardiovascular Clinical Trials. Journal Of The American College Of Cardiology 2024, 84: 2051-2062. PMID: 39505413, DOI: 10.1016/j.jacc.2024.08.069.Peer-Reviewed Original ResearchMeSH KeywordsArtificial IntelligenceCardiovascular DiseasesClinical Trials as TopicHumansRandomized Controlled Trials as TopicConceptsArtificial intelligenceIntegrate AIPatient privacyClinical trialsRandomized clinical trialsClinical event outcomesCardiovascular clinical trialsIntelligenceInaccurate resultsRandomized trialsInterpreting imagesCardiovascular therapyMedical decision makingDecision makingGold standardValidity of trial resultsClinical trial operationsPrivacy
2023
Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models
Rowhani-Farid A, Grewal M, Solar S, Eghrari A, Zhang A, Gross C, Krumholz H, Ross J. Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models. Scientific Data 2023, 10: 529. PMID: 37553403, PMCID: PMC10409750, DOI: 10.1038/s41597-023-02436-0.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicCross-Sectional StudiesInformation DisseminationNational Cancer Institute (U.S.)National Institutes of Health (U.S.)United StatesTemporal 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
2022
Identifying quality of life outcome patterns to inform treatment choices in ischemic cardiomyopathy
Mori M, Mark DB, Khera R, Lin H, Jones P, Huang C, Lu Y, Geirsson A, Velazquez EJ, Spertus JA, Krumholz HM. Identifying quality of life outcome patterns to inform treatment choices in ischemic cardiomyopathy. American Heart Journal 2022, 254: 12-22. PMID: 35932911, DOI: 10.1016/j.ahj.2022.07.007.Peer-Reviewed Original ResearchMeSH KeywordsCardiomyopathiesClinical Trials as TopicCoronary Artery BypassHumansMyocardial IschemiaQuality of LifeTreatment OutcomeConceptsCoronary artery bypass surgeryGuideline-directed medical therapyTreatment choiceBetter outcomesIschemic cardiomyopathyQOL outcomesQoL dataKansas City Cardiomyopathy Questionnaire overall summary scoreQOL trajectoriesOutcome patternsIschemic Heart Failure (STICH) trialHeart Failure TrialMain baseline predictorsArtery bypass surgeryOverall summary scoreDifferent treatment choicesLogistic regression modelsBypass surgeryMedical therapySurgical treatmentFailure TrialLife scoresQOL scoresPatient's probabilityBaseline predictors
2021
Leveraging 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
Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov
Pundi K, Perino AC, Harrington RA, Krumholz HM, Turakhia MP. Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov. JAMA Internal Medicine 2020, 180: 1398-1400. PMID: 32730617, PMCID: PMC7385669, DOI: 10.1001/jamainternmed.2020.2904.Peer-Reviewed Original ResearchPostmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original ResearchAssessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchMeSH KeywordsBiological ProductsClinical Trials as TopicCross-Sectional StudiesDrug ApprovalHumansPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approvalTime 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 Letters
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 ResearchRegistration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugsEarly 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 Questionnaires
2017
Merits 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 DisseminationPublicationsAssociation of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewersData Escrow and Clinical Trial Transparency.
Krumholz HM, Kim J. Data Escrow and Clinical Trial Transparency. Annals Of Internal Medicine 2017, 166: 893-894. PMID: 28384786, DOI: 10.7326/m17-0743.Peer-Reviewed Original ResearchTwo Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011
Bikdeli B, Punnanithinont N, Akram Y, Lee I, Desai NR, Ross JS, Krumholz HM. Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011. Journal Of The American Heart Association 2017, 6: e005285. PMID: 28325713, PMCID: PMC5524035, DOI: 10.1161/jaha.116.005285.Peer-Reviewed Original ResearchConceptsClinical outcome trialsOutcome trialsEndpoint trialsPrimary endpointCardiovascular trialsClinical outcome studiesClinical outcomesSurrogate markerPatient's perspectiveSurrogate endpointsOutcome studiesNew England JournalSample cohortTrial resultsTrialsSurrogate trialsEndpointPositive resultsAmerican MedicalInterventionHigh-impact journalsCohortIs Hemoglobin A1c the Right Outcome for Studies of Diabetes?
Lipska KJ, Krumholz HM. Is Hemoglobin A1c the Right Outcome for Studies of Diabetes? JAMA 2017, 317: 1017-1018. PMID: 28125758, PMCID: PMC5350060, DOI: 10.1001/jama.2017.0029.Commentaries, Editorials and LettersData Desert for Inferior Vena Caval Filters: Limited Evidence, Supervision, and Research
Bikdeli B, Ross JS, Krumholz HM. Data Desert for Inferior Vena Caval Filters: Limited Evidence, Supervision, and Research. JAMA Cardiology 2017, 2: 3-4. PMID: 27806161, DOI: 10.1001/jamacardio.2016.3764.Commentaries, Editorials and Letters
2016
Statins evidence: when answers also raise questions
Krumholz HM. Statins evidence: when answers also raise questions. The BMJ 2016, 354: i4963. PMID: 27628589, DOI: 10.1136/bmj.i4963.Peer-Reviewed Original ResearchOpen 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 Letters