title: Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond.
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.
authors.affiliation: Quantitative Solutions, Inc., Menlo Park, California, USA. jmandema@wequantify.com
authors.forename: J W
authors.initials: JW
authors.lastname: Mandema
authors.forename: M
authors.initials: M
authors.lastname: Gibbs
authors.forename: R A
authors.initials: RA
authors.lastname: Boyd
authors.forename: D R
authors.initials: DR
authors.lastname: Wada
authors.forename: M
authors.initials: M
authors.lastname: Pfister
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D006801:Humans; D019637:Orthopedic Procedures / Q000009:adverse effects*; D054556:Venous Thromboembolism / Q000517:prevention & control*
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D018501:Antirheumatic Agents