Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma.
Antineoplastic Agents
/ administration & dosage
Carcinoma, Renal Cell
/ drug therapy
Decision Making
Drug Approval
/ legislation & jurisprudence
Humans
Indazoles
Kidney Neoplasms
/ drug therapy
Pyrimidines
/ administration & dosage
Risk Assessment
Sulfonamides
/ administration & dosage
United States
United States Food and Drug 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:
03 2020
03 2020
Historique:
received:
15
04
2019
accepted:
19
06
2019
pubmed:
30
7
2019
medline:
29
10
2020
entrez:
30
7
2019
Statut:
ppublish
Résumé
Drug regulators such as the US Food and Drug Administration (FDA) make decisions about drug approvals based on benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision making about new drugs to treat renal cell carcinoma (RCC). Fifteen FDA decisions on RCC drugs based on clinical trials whose results were published from 2005 to 2018 were identified and analyzed. The benefits and risks of the new drug in each clinical trial were quantified relative to comparators (typically the control arm of the same clinical trial) to estimate whether the benefit-risk was positive or negative. A sensitivity analysis was demonstrated using pazopanib to explore the magnitude of uncertainty. FDA approval decision outcomes for the clinical trials assessed were consistent and logical using this benefit-risk framework.
Substances chimiques
Antineoplastic Agents
0
Indazoles
0
Pyrimidines
0
Sulfonamides
0
pazopanib
7RN5DR86CK
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
495-506Informations de copyright
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
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