2024
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 ResearchMeSH KeywordsClinical Trials as TopicCross-Sectional StudiesElectronic Health RecordsFeasibility StudiesHumansSubstance-Related DisordersConceptsElectronic 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 AdministrationTherapyConsent Form Reporting on ClinicalTrials.Gov, 2013-2023
Axson S, Ramachandran R, Lisenby A, Giordano N. Consent Form Reporting on ClinicalTrials.Gov, 2013-2023. JAMA Network Open 2024, 7: e2418895. PMID: 38904965, PMCID: PMC11193120, DOI: 10.1001/jamanetworkopen.2024.18895.Peer-Reviewed Original ResearchAssociations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments
Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersChronic DiseaseClinical Trials as TopicHumansMeta-Analysis as TopicTreatment OutcomeConceptsMeta-analysesChronic diseasesFood and Drug AdministrationMeta-regression analysisMeta-analyses of observational studiesSurrogate markerClinical outcomesClinical trialsMeta-analysisEvidence of associationPublished meta-analysesStrength of associationMeta-analyses of clinical trialsChronic disease treatmentFood and Drug Administration tableResults of meta-regression analysisOutcome pairsFood and Drug Administration approvalMain OutcomesData extractionSystematic reviewStatistically significant resultsObservational studyPooled analysisDrug Administration
2023
Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics
Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.Peer-Reviewed Original Research