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メタアナリシス的第IV相試験×ネットワークメタアナリシス×
分野疫学エビデンス統合
系統Process / pipelineProcess / pipeline
提唱年1990s–2000s (formalised as regulatory requirement context grew)2002
提唱者Developed through the convergence of meta-analytic methods (Glass, 1976; Hedges & Olkin, 1985) and post-marketing pharmacoepidemiology frameworksLumley (2002)
種類Evidence synthesis applied to post-marketing observational and trial dataMethod
原典Sutton, A. J., Abrams, K. R., Jones, D. R., Sheldon, T. A., & Song, F. (2000). Methods for Meta-Analysis in Medical Research. Wiley. ISBN: 978-0471490661Lumley, T. (2002). Network meta-analysis for indirect treatment comparisons. Statistics in Medicine, 21(16), 2313–2324. DOI ↗
別名Phase IV meta-analysis, post-marketing meta-analysis, pharmacoepidemiologic meta-analysis, post-approval systematic review and meta-analysisMixed Treatment Comparison, MTC, Indirect Comparison Meta-Analysis
関連31
概要A meta-analytic Phase IV study pools and quantitatively synthesises data from multiple Phase IV (post-marketing) sources — including observational cohorts, registries, spontaneous adverse-event databases, and post-approval randomised trials — to produce a single, more precise estimate of a drug or device's real-world effectiveness, safety, or utilisation pattern. By applying meta-analytic weighting to heterogeneous post-marketing evidence, it bridges the gap between tightly controlled pre-approval trials and the complexity of routine clinical practice.Network meta-analysis (NMA) is a systematic method for comparing multiple interventions simultaneously within a single analytical framework, incorporating both direct evidence (head-to-head trials) and indirect evidence (comparisons via common comparators). First formalized by Lumley in 2002, NMA allows researchers to rank treatments and quantify comparative effectiveness even when some treatment pairs have never been directly studied.
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ScholarGate手法を比較: Meta-analytic Phase IV Study · Network Meta-Analysis. 2026-06-17に以下より取得 https://scholargate.app/ja/compare