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我们是否已经准备好进行报销了？真实世界证据在卫生技术评估方面的发展综述：第 12 部分。

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 12.

机构信息

Lane Clark & Peacock, London, W1U 1DQ, UK.

Department of Population Health Sciences, King's College London, London, SE1 3QD, UK.

出版信息

J Comp Eff Res. 2023 Jul;12(7):e230092. doi: 10.57264/cer-2023-0092. Epub 2023 Jun 22.

DOI:10.57264/cer-2023-0092
PMID:37345541
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10508304/
Abstract

In this latest update we highlight the final results from the RCT-DUPLICATE initiative, the publication of guidance from Haute Autorité de Santé (HAS), the joint viewpoint from the Institute for Quality and Efficiency in HealthCare (IQWIG) and the Belgian HealthCare Knowledge Center, and a position from the European Organization for Research and Treatment of Cancer (EORTC). Finally, we discuss how the NICE RWE framework has been implemented to allow consideration of RWE external control arms.

摘要

在本次最新更新中，我们重点介绍了 RCT-DUPLICATE 计划的最终结果、法国公共卫生高级管理局 (HAS) 的指南发布、德国质量与效率研究所 (IQWIG) 和比利时医疗保健知识中心的联合观点，以及欧洲癌症研究与治疗组织 (EORTC) 的立场。最后，我们讨论了如何实施 NICE 的 RWE 框架，以允许考虑 RWE 的外部对照臂。

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本文引用的文献

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Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials.非随机数据库分析模拟随机临床试验：32 项临床试验的结果。
JAMA. 2023 Apr 25;329(16):1376-1385. doi: 10.1001/jama.2023.4221.
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R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 11.我们是否已经准备好进行报销？与健康技术评估相关的真实世界证据的最新进展综述：第 11 部分。
J Comp Eff Res. 2023 May;12(5):e230008. doi: 10.57264/cer-2023-0008. Epub 2023 Apr 13.
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Defining the role of real-world data in cancer clinical research: The position of the European Organisation for Research and Treatment of Cancer.定义真实世界数据在癌症临床研究中的作用：欧洲癌症研究和治疗组织的立场。
Eur J Cancer. 2023 Jun;186:52-61. doi: 10.1016/j.ejca.2023.03.013. Epub 2023 Mar 21.
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Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy?用真实世界数据取代随机对照试验用于监管决策：自我实现的预言？
BMJ. 2023 Mar 2;380:e073100. doi: 10.1136/bmj-2022-073100.
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Rapid access to innovative medicinal products while ensuring relevant health technology assessment. Position of the French National Authority for Health.在确保进行相关卫生技术评估的同时，快速获取创新药品。法国国家卫生管理局的立场。
BMJ Evid Based Med. 2024 Jan 19;29(1):1-5. doi: 10.1136/bmjebm-2022-112091.
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J Comp Eff Res. 2023 Jan;12(1):e220194. doi: 10.2217/cer-2022-0194. Epub 2022 Dec 1.
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