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国家卫生技术评估中间接治疗比较分析及行业提交要求

Analysis of indirect treatment comparisons in national health technology assessments and requirements for industry submissions.

作者信息

Es-Skali Ischa J, Spoors John

机构信息

RJW & Partners, London, UK.

出版信息

J Comp Eff Res. 2018 Apr;7(4):397-409. doi: 10.2217/cer-2017-0092. Epub 2018 Mar 28.

DOI:10.2217/cer-2017-0092
PMID:29589475
Abstract

To determine the preferred methodologies of health technology assessment (HTA) agencies across Europe, Canada and Australia to ascertain acceptance of indirect treatment comparisons (ITC) as a source of comparative evidence. A review of official submission guidelines and analysis of comments in HTA submissions that have used different ITC methodologies. ITC is generally accepted as a technique that allows demonstration of noninferiority to a comparator provided the chosen methodology and underlying assumptions are clear and justified. However, HTA agencies are more likely to closely scrutinize submitted data and evaluate statistical significance of results when superiority is claimed. In addition, the HTA agencies in scope tended to be cautious and only accept ITC data as support for similarity of treatments.

摘要

为确定欧洲、加拿大和澳大利亚各国卫生技术评估(HTA)机构的首选方法,以查明对间接治疗比较(ITC)作为比较证据来源的接受情况。对官方提交指南进行审查,并分析使用不同ITC方法的HTA提交材料中的评论。一般认为,ITC是一种技术,只要所选方法和基本假设清晰合理,就能够证明与对照相比非劣效。然而,当声称具有优效性时,HTA机构更有可能仔细审查提交的数据并评估结果的统计学显著性。此外,本研究范围内的HTA机构往往持谨慎态度,仅接受ITC数据作为治疗相似性的支持。

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