Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond

Clin Pharmacol Ther. 2011 Dec;90(6):766-9. doi: 10.1038/clpt.2011.242.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Comment

MeSH terms

  • Antibodies, Monoclonal / therapeutic use*
  • Anticoagulants / therapeutic use*
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Humans
  • Orthopedic Procedures / adverse effects*
  • Venous Thromboembolism / prevention & control*

Substances

  • Antibodies, Monoclonal
  • Anticoagulants
  • Antirheumatic Agents