BMJ · 2018 · 28 citations · 13 references
PharmacyPharmacologyClinical PharmacologyDrug Approval ProcessesEvidence-based PracticeClinical Trial Approval ProcessesClinical Trial DocumentationClinical TrialsDrug ApprovalDrug Information ResourcesEvidence-based MedicineClinical Evidence ReviewClinical Pharmacology EvidenceClinical Trial Information TranslationDrug Approval DatabasesDrug DocumentationEvidence Standards For ApprovalEvidence Synthesis For ApprovalFda Drug Regulation
Evidence syntheses may benefit from using aggregated clinical trial information in approval documents published online by the US Food and Drug Administration (FDA). We provide practical guidance on how to access and use this source of information for evidence syntheses on treatment effects of drugs and therapeutic biologics.
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Practical methods for incorporating summary time-to-event data into meta-analysis
Jayne F. Tierney, Lesley Stewart, Davina Ghersi et al. · Trials · 2007 · 6.4K citations · Full text