2024
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study
Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.Peer-Reviewed Original ResearchNational Comprehensive Cancer NetworkNational Comprehensive Cancer Network guidelinesComprehensive Cancer NetworkFood and Drug AdministrationCancer NetworkUS Food and Drug AdministrationCategories of evidenceAccelerated approvalCross sectional studyDrug treatmentConfirmatory trialsClinical benefitTrial resultsOncological indicationsTraditional approvalGuideline recommendationsOutcome measuresSectional studyApproval statusFDA decisionRecommended alignmentOncologyUpdate recommendationsPostapproval trialsGuidelines
2022
Consistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy designSpending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Skydel JJ, Egilman AC, Wallach JD, Ramachandran R, Gupta R, Ross JS. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. JAMA Health Forum 2022, 3: e221158. PMID: 35977252, PMCID: PMC9142876, DOI: 10.1001/jamahealthforum.2022.1158.Peer-Reviewed Original ResearchConceptsSurrogate end pointsCross-sectional studyClinical benefitConfirmation of benefitEnd pointOriginal indicationClinical outcomesUS FoodConfirmatory trialsMedicaid ServicesPrimary end pointUnproven clinical benefitsTrial end pointsClinical trial resultsTypes of drugsPostapproval trialsAccelerated approvalClinical trialsMAIN OUTCOMEDrug AdministrationMedicare Part BStandard approvalConversion statusSupplemental indicationsTrial results
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 resultsTrials
2017
Two 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 journalsCohort
2016
Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. The BMJ 2016, 352: i637. PMID: 26888209, PMCID: PMC4768882, DOI: 10.1136/bmj.i637.Peer-Reviewed Original ResearchConceptsAcademic medical centerInterventional clinical trialsClinical trialsMedical CenterStudy completionPrimary completion dateClinical trial resultsReporting of resultsSectional analysisInterventional trialsProportion of trialsTrial resultsTrialsMonthsPhase IIManual reviewLead investigatorUnited StatesProportionRate of publicationReportingCompletionPatientsCenterCompliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
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
2009
Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLOS Medicine 2009, 6: e1000144. PMID: 19901971, PMCID: PMC2728480, DOI: 10.1371/journal.pmed.1000144.Peer-Reviewed Original ResearchConceptsOptional data elementsClinical trialsTrial publicationsInternet-based registryCompleteness of registrationCross-sectional analysisSelective publicationPrimary outcomeUS National LibraryReporting TrialsPublication statusTrial resultsPhase ITrialsData elementsSignificant differencesEditors' SummaryEnd dateSystematic protocolClinicalTrials