Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.
Antineoplastic Agents
/ administration & dosage
Decision Making
Drug Approval
/ organization & administration
Humans
Kaplan-Meier Estimate
Melanoma
/ drug therapy
Neoplasm Staging
Randomized Controlled Trials as Topic
Research Design
Risk Assessment
Uncertainty
United States
/ epidemiology
United States Food and Drug Administration
/ organization & administration
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
08
01
2019
accepted:
17
03
2019
pubmed:
18
4
2019
medline:
31
3
2020
entrez:
18
4
2019
Statut:
ppublish
Résumé
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.
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
123-135Informations de copyright
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.