Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma
| Autor: | Janet Woodcock, Karthik Gurumurthi, Chana Weinstock, Paul G. Kluetz, Richard Pazdur, Harpreet Singh, Reuben Domike, G. K. Raju |
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| Rok vydání: | 2019 |
| Předmět: |
Drug
medicine.medical_specialty Indazoles media_common.quotation_subject Decision Making MEDLINE Antineoplastic Agents 030226 pharmacology & pharmacy Risk Assessment Pazopanib 03 medical and health sciences 0302 clinical medicine Renal cell carcinoma medicine Humans Pharmacology (medical) Intensive care medicine Adverse effect Carcinoma Renal Cell Drug Approval media_common Pharmacology Sulfonamides business.industry United States Food and Drug Administration Benefit risk analysis medicine.disease Kidney Neoplasms United States Clinical trial Pyrimidines 030220 oncology & carcinogenesis business Risk assessment medicine.drug |
| Zdroj: | Clinical pharmacology and therapeutics. 107(3) |
| ISSN: | 1532-6535 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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