title: Benefit-Risk Analysis for Decision-Making: An Approach.
abstract: The analysis of benefit and risk is an important aspect of decision-making throughout the drug lifecycle. In this work, the use of a benefit-risk analysis approach to support decision-making was explored. The proposed approach builds on the qualitative US Food and Drug Administration (FDA) approach to include a more explicit analysis based on international standards and guidance that enables aggregation and comparison of benefit and risk on a common basis and a lifecycle focus. The approach is demonstrated on six decisions over the lifecycle (e.g., accelerated approval, withdrawal, and traditional approval) using two case studies: natalizumab for multiple sclerosis (MS) and bedaquiline for multidrug-resistant tuberculosis (MDR-TB).
authors.affiliation: Light Pharma, Inc., Cambridge, Massachusetts, USA.|M.I.T. Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
authors.forename: G K
authors.initials: GK
authors.lastname: Raju
authors.affiliation: Light Pharma, Inc., Cambridge, Massachusetts, USA.
authors.forename: K
authors.initials: K
authors.lastname: Gurumurthi
authors.affiliation: Light Pharma, Inc., Cambridge, Massachusetts, USA.
authors.forename: R
authors.initials: R
authors.lastname: Domike
mesh_terms: D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use; D003657:Decision Making; D064687:Diarylquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use; D009103:Multiple Sclerosis / Q000188:drug therapy; D000069442:Natalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000995:Antitubercular Agents; D064687:Diarylquinolines; D007155:Immunologic Factors; D000069442:Natalizumab; C493870:bedaquiline