2019
Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals
Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone G, Ross JS, Krumholz HM. Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals. Circulation 2019, 140: 379-389. PMID: 31177811, PMCID: PMC8416048, DOI: 10.1161/circulationaha.119.040214.Peer-Reviewed Original ResearchConceptsNoninferiority marginNoninferiority trialCardiovascular trialsAllocation concealmentLower riskOpen labelHazard ratioRelative riskMethodological qualityProportion of trialsIndependent reviewersRisk differenceNew England JournalNoninferiorityHigh-impact journalsNew interventionsTrialsCohortDiscrepant resultsProtocol analysisTime trendsRiskTreatInterventionFactors
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
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 publicationReportingCompletionPatientsCenter