Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study
Janda G, Jeffery M, Ramachandran R, Ross J, Wallach J. Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study. BMC Medical Research Methodology 2024, 24: 187. PMID: 39198727, PMCID: PMC11351457, DOI: 10.1186/s12874-024-02307-1.Peer-Reviewed Original ResearchConceptsElectronic health record dataElectronic health recordsSubstance use disordersCross-sectional studyAdministrative claimsEligibility criteriaTrials evaluating treatmentPublic health systemClinical trialsIntroductionReal-world evidenceSafety of medical productsHealth recordsHealth systemReal-world dataTrial emulationPrimary end pointInsurance claimsPhase 2Placebo comparatorActive comparatorInterventionEligibilityEnd pointsTrialsPremarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.Peer-Reviewed Original ResearchConceptsFood and Drug Administration tableFood and Drug AdministrationSurrogate end pointsSurrogate markerPostmarketing studiesEnd pointsTraditional approvalCross-sectional studyClinical benefitAccelerated approvalTherapy designClinically significant end pointsReview of therapeuticsPrimary end pointUS Food and Drug AdministrationTrial end pointsSignificant end pointsPostmarketing requirementsPreliminary clinical evidenceApproval pathwayPivotal trialsClinical evidenceBreakthrough therapiesDrug AdministrationTherapyFunding of evidence included within public comments submitted to inform Medicare national coverage determinations
Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.Peer-Reviewed Original ResearchCenters for Medicare & Medicaid ServicesScientific journal articlesNational Coverage DeterminationPublic commentsCoverage determinationCross-sectional studyMedicare national coverage determinationsJournal articlesMedicare coverage decisionsCoverage of itemsMedicaid ServicesMedicare beneficiariesCommentsMedicare coverageGreater fundingMedicareAuthor disclosuresArticleCoverage decisionsEvaluation of benefitsFunding statementsSupport researchPremarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.Peer-Reviewed Original Research