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Benefit‐Risk Analysis for Decision‐Making: An Approach
Author(s) -
Raju GK,
Gurumurthi K,
Domike R
Publication year - 2016
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 - 10.1002/cpt.507
Subject(s) - risk analysis (engineering) , food and drug administration , natalizumab , decision analysis , bedaquiline , tuberculosis , medicine , multiple sclerosis , mycobacterium tuberculosis , statistics , mathematics , pathology , psychiatry
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).