2018
Registration, 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 drugsDrugs
2017
Association 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 documentsDrugsDiabetesFDAAAReviewers
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
2005
The Impact of Clinical Trials on the Use of Hormone Replacement Therapy
Kim N, Gross C, Curtis J, Stettin G, Wogen S, Choe N, Krumholz HM. The Impact of Clinical Trials on the Use of Hormone Replacement Therapy. Journal Of General Internal Medicine 2005, 20: 1026-1031. PMID: 16307628, PMCID: PMC1490267, DOI: 10.1111/j.1525-1497.2005.0221.x.Peer-Reviewed Original ResearchMeSH KeywordsAge DistributionAgedClinical Trials as TopicFemaleHormone Replacement TherapyHumansInformation DisseminationInsurance, Pharmaceutical ServicesLongitudinal StudiesMiddle AgedPatient Acceptance of Health CarePractice Patterns, Physicians'Retrospective StudiesTreatment RefusalUnited StatesConceptsWomen's Health InitiativeHormone replacement therapyHRT useHRT discontinuationReplacement therapyHealth initiativesHormone replacement therapy useLocal practice patternsHRT prescriptionHRT usersMarked regional variationPrescription fillingTherapy useClinical behaviorClinical trialsPractice patternsSubstantial geographic variationTrial publicationsDiscontinuationHealth databasesTrial dataAge groupsRapid effectsWest South CentralTrial results