2019
Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence
Bartlett VL, Dhruva SS, Shah ND, Ryan P, Ross JS. Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence. JAMA Network Open 2019, 2: e1912869. PMID: 31596493, PMCID: PMC6802419, DOI: 10.1001/jamanetworkopen.2019.12869.Peer-Reviewed Original ResearchConceptsPrimary end pointClinical trialsReal-world evidenceEnd pointElectronic health recordsEHR dataExclusion criteriaClinical trial evidenceRandomized clinical trialsHigh-impact general medical journalsReal-world populationInsurance claimsTraditional clinical trialsCross-sectional analysisSame clinical questionPercentage of trialsPrimary outcomeClinical outcomesClinical evidenceTrial evidenceTrial populationTrial inclusionObservational studyAdministrative claimsMAIN OUTCOME
2016
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Trials 2016, 17: 31. PMID: 26792624, PMCID: PMC4720997, DOI: 10.1186/s13063-015-1107-1.Peer-Reviewed Original ResearchConceptsMedian numberDrug trialsGeneral medical journalsComposite primary outcome measureStudy designTerms of blindingPrimary outcome measureTrials of drugsHigh-impact general medical journalsKey trial characteristicsIndustry-funded trialsMedical journalsAdverse eventsCategories of trialsTrial characteristicsOutcome measuresStudy populationSafety outcomesBlinded researcherStudy characteristicsDescriptive studyTrial documentationTrialsSignificant differencesMarketing trials
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