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Novel quantitative methods for drug benefit-risk assessment in regulatory decision-making: A case study and policy analysis.

机译：监管决策中药物利益风险评估的新型定量方法：案例研究和政策分析。

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摘要

The United States Food and Drug Administration and European Medicines Agency are evaluating quantitative methods for assessing the benefits and risks of pharmaceuticals to facilitate regulatory decision-making. Health outcomes modeling, the modeling of a drug's net benefit by quantifying its effects on health outcomes, constitutes one method under consideration by regulators. Little has been published on the feasibility of health outcomes modeling for regulatory use. Rosiglitazone is a type 2 diabetes drug with a controversial benefit-risk tradeoff, making it an intuitive example for examining health outcomes modeling as a regulatory aid. We sought to estimate the incremental net benefit of rosiglitazone monotherapy versus comparators, to evaluate the effect of emergent evidence on a product's net benefit, and to compare model results with past regulatory decisions concerning rosiglitazone. Our model results questioned the initial decision to approve rosiglitazone for monotherapy use since our estimates projected it to be inferior to glyburide. Only postmarketing efficacy data supported such an indication versus glyburide, yet postmarketing data did not support such an indication versus metformin due to sufficient uncertainty in the risk of drug-attributable cardiovascular death. With growing interest in multiple approaches for quantitative benefit-risk assessment, we also sought to compare modeling with other methods. We described three quantitative methods for improving regulatory benefit-risk assessment: health outcomes modeling, stated-preferences for benefit-risk tradeoffs, and multi-criteria decision analysis. We surveyed technical experts to describe current problems in benefit-risk assessment and to identify attributes needed to evaluate whether quantitative methods could address these problems. While each method has been tested using historical examples, they have yet to be evaluated using common measurement criteria. We developed conceptual and operational criteria by which we could prospectively evaluate the potential success of these three methods alongside the existing approach for assessing drug benefits and risks for regulatory decision-making. Since each method was found to possess both strengths and weaknesses for use in regulatory decision-making, feasibility of implementation will dictate which method might be adopted.
机译：美国食品药品监督管理局和欧洲药品管理局正在评估定量方法，以评估药品的利弊，以促进监管决策。健康结果建模是通过量化药物对健康结果的影响来对药物净收益进行建模的模型，是监管机构正在考虑的一种方法。关于健康结果建模用于法规使用的可行性的报道很少。罗格列酮是一种2型糖尿病药物，在获益风险-风险方面存在折衷，使之成为检查健康结果模型作为监管辅助手段的直观示例。我们试图估计罗格列酮单药治疗相对于比较者的增量净收益，评估新兴证据对产品净收益的影响，并将模型结果与过去有关罗格列酮的监管决定进行比较。我们的模型结果对批准罗格列酮用于单药治疗的最初决定提出了质疑，因为我们的估计表明罗格列酮不如格列本脲。只有上市后疗效数据支持格列本脲和乙二甲双胍的这种适应症，但由于药物归因的心血管死亡风险有足够的不确定性，上市后数据不支持这种适应症与二甲双胍。随着人们越来越关注量化收益风险评估的多种方法，我们还试图将建模与其他方法进行比较。我们描述了三种改进监管利益风险评估的定量方法：健康结果建模，利益风险权衡的陈述偏好和多标准决策分析。我们对技术专家进行了调查，以描述利益风险评估中的当前问题，并确定评估定量方法是否可以解决这些问题所需的属性。尽管已使用历史示例对每种方法进行了测试，但尚未使用通用的测量标准对其进行评估。我们制定了概念和操作标准，通过这些标准，我们可以前瞻性地评估这三种方法的潜在成功以及现有的评估药物益处和监管决策风险的方法。由于发现每种方法在监管决策中都具有优势和劣势，因此实施的可行性将决定采用哪种方法。

著录项

  • 作者

    Cross, James T.;

  • 作者单位

    University of Washington.;

  • 授予单位 University of Washington.;
  • 学科 Health Sciences Pharmacy.;Health Sciences Epidemiology.;Health Sciences Public Health.
  • 学位 Ph.D.
  • 年度 2009
  • 页码 84 p.
  • 总页数 84
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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