2023
Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.Peer-Reviewed Original Research
2021
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, Ross JS. Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. JAMA Network Open 2021, 4: e2133667. PMID: 34751763, PMCID: PMC8579227, DOI: 10.1001/jamanetworkopen.2021.33667.Peer-Reviewed Original ResearchFeasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report
Jiang G, Dhruva SS, Chen J, Schulz WL, Doshi AA, Noseworthy PA, Zhang S, Yu Y, Young H, Brandt E, Ervin KR, Shah ND, Ross JS, Coplan P, Drozda JP. Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report. Journal Of The American Medical Informatics Association 2021, 28: 2241-2250. PMID: 34313748, PMCID: PMC8449615, DOI: 10.1093/jamia/ocab117.Peer-Reviewed Original ResearchMeSH KeywordsElectronic Health RecordsFeasibility StudiesHealth Information SystemsInformaticsNatural Language ProcessingConceptsReal-world dataHealth information technology systemsInformation technology systemsUnique device identifiersMaturity modelNatural language processing toolsTechnology systemsUnstructured data elementsNatural language processingCommon data modelData quality frameworkLanguage processing toolsComputable phenotypeInformatics approachElectronic health recordsClinical data systemsData modelLanguage processingDevice identifiersStandardized codesData elementsProcessing toolsInformatics technologiesData captureHealth records
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