Measures for conducting comparative benefit: Risk assessment

Measures for conducting comparative benefit: Risk assessment
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DOI:
10.1177/009286150804200304
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发表时间:
2008-01-01
影响因子:
--
通讯作者:
Pritchett, Yili
Pritchett, Yili
中科院分区:
其他
文献类型:
--
作者:
Chuang-Stein, Christy;Entsuah, Richard;Pritchett, Yili

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在这篇文章中,我们回顾了已经提出进行比较效益的定量措施:风险评估。风险评估可以在社会层面(推荐药物批准或采用医疗政策)或在个人层面(进行治疗选择)进行。获益:风险评估涉及获益和风险之间的平衡。基于所有信息做出决策的需要迫使我们以结构化的方式认真思考利益和风险之间的权衡。尽管我们在本文中讨论了促进获益:风险评估的措施,但我们想提醒读者,它不能单独取代对疗效和安全性的严格评估。相反,它通过将安全性和有效性评估统一在一起,补充了传统上分开的安全性和有效性分析。
In this article, we review quantitative measures that have been proposed to conduct comparative benefit:risk assessment. Comparative benefit:risk assessment could be conducted at the societal level (recommending drug approval or the adoption of a medical policy) or at the individual level (making a treatment selection). Benefit:risk assessment involves balancing between benefit and risk. The need to make decisions based on all information forces us to think diligently on the trade-off between benefit and risk in a structured manner. Even though we discuss measures to facilitate benefit:risk assessment in this article, we want to remind the readers that it cannot replace the rigorous assessment of efficacy and safety individually. Rather, it complements the traditionally separate safety and efficacy analysis by bringing safety and efficacy assessment together in a unified approach.