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Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma
Author(s) -
Raju G. K.,
Gurumurthi Karthik,
Domike Reuben,
Theoret Marc R.,
Pazdur Richard,
Woodcock Janet
Publication year - 2019
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.1461
Subject(s) - food and drug administration , vemurafenib , drug , medicine , clinical trial , risk analysis (engineering) , risk assessment , drug approval , pharmacology , computer science , metastatic melanoma , cancer , computer security
Drug regulators seek to make decisions regarding drug approvals based on analysis of the relevant benefits and risks. In this work, 25 US Food and Drug Administration ( FDA ) decisions on melanoma drugs were identified and analyzed based on clinical trial results published between 1999 and 2017. In each case, the benefits and risks of the new drug in each clinical trial relative to a comparator (typically the control arm of the same clinical trial) were quantified. The benefits and risks were analyzed using a common scale to allow for direct comparison. A sensitivity analysis was conducted using vemurafenib to explore the magnitude of uncertainty in the quantitative assessments. The associated FDA decision outcomes of the new drugs were consistent with the benefits and risks quantified in this work.