Premium
Model‐Based Meta‐Analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond
Author(s) -
Mandema J W,
Gibbs M,
Boyd R A,
Wada D R,
Pfister M
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2011.242
Subject(s) - clinical pharmacology , drug development , risk analysis (engineering) , drug , intensive care medicine , medicine , health care , computer science , management science , pharmacology , engineering , political science , law
High development cost, low development success, cost‐disciplined health‐care policies, and intense competition demand an efficient drug development process. New compounds need to bring value to patients by being safe, efficacious, and cost‐effective as compared with existing treatment options. Model‐based meta‐analysis (MBMA) facilitates integration and utilization of summary‐level efficacy and safety data, providing a quantitative framework for comparative efficacy and safety assessment. 1 , 2 This Commentary discusses the application and limitations of MBMA in drug development. Clinical Pharmacology & Therapeutics (2011) 90 6, 766–769. doi: 10.1038/clpt.2011.242