2019
Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O'Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand SL, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. American Heart Journal 2019, 218: 110-122. PMID: 31726314, DOI: 10.1016/j.ahj.2019.09.002.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomedical ResearchCardiovascular DiseasesCoronary Artery BypassData AccuracyDatabases, FactualFee-for-Service PlansFemaleFollow-Up StudiesHumansInpatientsInsurance Claim ReviewKaplan-Meier EstimateMaleMedical Record LinkageMedicareMulticenter Studies as TopicMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicRetrospective StudiesStrokeUnited StatesConceptsCardiovascular clinical trialsMyocardial infarctionEvent ratesClinical researchRandomized cardiovascular clinical trialsClinical trialsTrial participantsClinical events committee’s adjudicationsOverall cardiovascular event ratesTreatment effectsAnnual event rateCardiovascular event ratesMedicare inpatient claimsClinical trial dataOutcomes of interestSite-reported eventsCase concordanceCardiovascular outcomesRetrospective studyHigher event ratesInpatient claimsClinical dataMedicare claimsClaims dataDuke DatabaseSharing 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 ResearchConceptsClinical 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
Age 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 resultsTrialsAccurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population. BMJ Open 2018, 8: e021685. PMID: 30037874, PMCID: PMC6059296, DOI: 10.1136/bmjopen-2018-021685.Peer-Reviewed Original ResearchConceptsSystolic Blood Pressure Intervention TrialFramingham risk scoreCardiovascular riskRisk scoreStudy populationStudy participantsNon-diabetic adultsTotal study populationHigh-risk populationClinical trial dataClinical trial sitesTrial populationIntervention trialsRisk populationsNew England JournalIndependent investigatorsTrial dataSecondary analysisSPRINT trialSPRINT dataTrialsRiskScoresParticipantsPopulationThe Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data
Wilcox MA, Savitz AJ, Addington AM, Gray GS, Guinan EC, Jackson JW, Lehner T, Normand SL, Ranu H, Senthil G, Spertus J, Valeri L, Ross JS. The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data. Schizophrenia 2018, 4: 14. PMID: 29950580, PMCID: PMC6021398, DOI: 10.1038/s41537-018-0055-7.Commentaries, Editorials and LettersClinical trialsOverall public health burdenSchizophrenia ProjectPublic health burdenClinical trial dataReal-world studyTranslational scienceHarvard CatalystHealth burdenTherapeutic safetyTrial dataBrain diseasesBiology of diseaseGold standardBest treatmentPharmaceutical safetyDisease etiologyTrialsDiseaseEfficacyProject investigatorsSafetyEtiologySchizophrenia
2016
Availability 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 ResearchConceptsIndividual participant-level dataLarge cardiovascular trialsCardiovascular trialsParticipant-level dataClinical trial dataPharmaceutical companiesMajor pharmaceutical companiesIndustry-sponsored clinical trialsInterventional trialsAvailable trialsClinical trialsTrial dataTrialsPatientsSpecific reasons
2013
Implications of clinical trial data sharing for medical writers
Ross J, Krumholz H. Implications of clinical trial data sharing for medical writers. Medical Writing 2013, 22: 45-48. DOI: 10.1179/2047480612z.00000000085.Commentaries, Editorials and Letters
2012
Sharing of clinical trial data among trialists: a cross sectional survey
Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS. Sharing of clinical trial data among trialists: a cross sectional survey. The BMJ 2012, 345: e7570. PMID: 23169870, PMCID: PMC3502744, DOI: 10.1136/bmj.e7570.Peer-Reviewed Original ResearchConceptsClinical trial dataTrial dataGeneral medical journalsHigh-impact general medical journalsCross-sectional surveyDe-identified dataMedical journalsClinical trialsTrial fundersClinical trialistsSectional surveyTrialistsTrialsInvestigatorsExperiences of sharingPrevalence of dataPotential respondentsHigh impact factorAppropriate data usePrevalenceRespondents
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose