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 pointsTrialsHarnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies
Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.Peer-Reviewed Original ResearchUS Food and Drug AdministrationFood and Drug AdministrationClinical trialsReference standardDrug AdministrationInternational Federation of Pharmaceutical ManufacturersTrial designPhases of clinical trialsEuropean Medicines AgencyEnrollment targetsPharmaceutical company websitesTrial recruitmentPatient populationImprove patient awarenessInternational FederationMedicines AgencyWorld Health OrganizationEligibility criteriaCompany policiesDiversity policiesStakeholder guidanceTrialsFDAPharmaceutical Research and Manufacturers of AmericaCharacteristics of participants