2024
Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence
Mooghali M, Zhou T, Ross J. Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence. BMJ Open 2024, 14: e090376. PMID: 39461853, PMCID: PMC11529451, DOI: 10.1136/bmjopen-2024-090376.Peer-Reviewed Original ResearchConceptsPhase 2 trialPhase 3 trialBox warningAtrial fibrillation patientsPostmarketing evidenceEvidence of safetyOral anticoagulantsFibrillation patientsPostmarketing studiesCross-sectional analysisDegree of concordanceStroke preventionStudy requirementsPostmarketingEfficacy evidenceRegulatory agenciesDrugPostmarketing requirementsInterpretation of resultsEfficacyHealth CanadaSample sizeSafety evidenceConcordanceEndpoint
2021
Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals
Shi X, Ross JS, Amancharla N, Niforatos JD, Krumholz HM, Wallach JD. Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals. JAMA Network Open 2021, 4: e212110. PMID: 33734411, PMCID: PMC7974637, DOI: 10.1001/jamanetworkopen.2021.2110.Peer-Reviewed Original Research