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 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 measuresPostmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
Wallach JD, Luxkaranayagam AT, Dhruva SS, Miller JE, Ross JS. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis. BMC Medicine 2019, 17: 117. PMID: 31203816, PMCID: PMC6572730, DOI: 10.1186/s12916-019-1344-3.Peer-Reviewed Original ResearchConceptsNew clinical trialsClinical trialsPostmarketing commitmentFDA approvalPeer-reviewed journalsNovel drugsPharmaceutical companiesCross-sectional analysisRate of completionRates of registrationClinical studiesPublic reporting requirementsFirst approvalTherapeutic evaluationUS FoodDrug AdministrationTrialsNew drugsFDA documentsBiologicsFDADrugsFDA recordsApprovalStatusAnalysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. JAMA Network Open 2019, 2: e193410. PMID: 31074812, PMCID: PMC6512282, DOI: 10.1001/jamanetworkopen.2019.3410.Peer-Reviewed Original ResearchConceptsPostapproval clinical trialsClinical trialsPrimary completion datePostmarketing requirementsNovel therapeuticsDrug AdministrationUS FoodNew indicationsPharmaceutical companiesNew clinical studiesCross-sectional analysisClinical outcomesStudy design elementsPatient populationUnapproved indicationsEfficacy dataClinical studiesStudy completionMAIN OUTCOMEFirst approvalMost trialsTrialsFDATherapeutic approvalsTherapeutics
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
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
2011
Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial
Krumholz SD, Egilman DS, Ross JS. Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial. JAMA Internal Medicine 2011, 171: 1100-1107. PMID: 21709111, PMCID: PMC3319750, DOI: 10.1001/archinternmed.2011.241.Peer-Reviewed Original Research