Incorporating patient-preference evidence into regulatory decision making

Ho Martin P.; Gonzalez Juan Marcos; Lerner Herbert P.; Neuland Carolyn Y.; Whang Joyce M.; McMurry-Heath Michelle; Hauber A. Brett; Irony Telba

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Incorporating patient-preference evidence into regulatory decision making

机译：将患者偏爱的证据纳入监管决策

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Background Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health.

机译：背景患者在决定应为他们提供何种治疗方法方面扮演着独特的角色，管理机构在做出治疗批准决定时应考虑他们的偏好。这是第一项旨在获得定量患者偏爱证据以告知食品和药物管理局药品和放射卫生管理中心法规批准决定的研究。

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《Surgical Endoscopy》 |2015年第10期|共10页
作者
Ho Martin P.; Gonzalez Juan Marcos; Lerner Herbert P.; Neuland Carolyn Y.; Whang Joyce M.; McMurry-Heath Michelle; Hauber A. Brett; Irony Telba;
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原文格式 PDF
正文语种 eng
中图分类诊断学;
关键词
Patient preferences; Weight-loss devices; Obesity treatment; FDA; Benefit-risk assessment; Regulatory-approval decisions;

机译：患者喜好;减肥设备;肥胖症治疗;FDA;受益风险评估;监管批准决定;

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专利

1. Incorporating patient-preference evidence into regulatory decision making [J] . Ho Martin P., Gonzalez Juan Marcos, Lerner Herbert P., Surgical Endoscopy . 2015,第10期

机译：将患者偏爱的证据纳入监管决策
2. Incorporating research evidence into decision-making processes: researcher and decision-maker perceptions from five low- and middle-income countries [J] . Zubin Shroff, Bhupinder Aulakh, Lucy Gilson, Health Research Policy and Systems . 2015,第1期

机译：将研究证据纳入决策过程：研究人员和决策者从五个低收入和中等收入国家的看法
3. Evidence-based urology in practice: incorporating patient values in evidence-based clinical decision making [J] . Steven E. Canfield, Philipp Dahm, the Evidence-Based Urology Working Group BJU International . 2010,第1期

机译：实践中的循证泌尿外科：将患者价值纳入循证临床决策
4. Incorporating exposure driven approaches and in vitro data into regulatory decision making [C] . N. Kleinstreuer Annual conference of the International Society of Exposure Science . 2017

机译：将暴露驱动的方法和体外数据纳入监管决策
5. Regulatory fit can be more than a feeling: Evidence of facilitated processing for prevention fit in investment decision-making contexts [D] . Pew, Ethan. 2010

机译：监管契合不只是一种感觉：在投资决策环境中促进预防处理的证据
6. Incorporating research evidence into decision-making processes: researcher and decision-maker perceptions from five low- and middle-income countries [O] . Zubin Shroff, Bhupinder Aulakh, Lucy Gilson, 2015

机译：将研究证据纳入决策过程：来自五个中低收入国家的研究人员和决策者的看法
7. Evidence and belief in regulatory decisions - Incorporating expected utilityinto decision modelling [O] . Li J., Davies Gareth J., Kendall Graham, 2012

机译：监管决策的证据和信念-纳入预期效用进入决策模型

Incorporating patient-preference evidence into regulatory decision making

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