Model-based Meta-analysis for Comparative Efficacy and Safety: Application in Drug Development and Beyond

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. This Commentary discusses the application and limitations of MBMA in drug development.

Author(s): Jaap Mandema, Megan Gibbs, Rebecca Boyd, Russell Wada, Marc Pfister

Year: December 1, 2011