ESMO-Magnitude of Clinical Benefit Scale version 1.1
ESMO-Magnitude of Clinical Benefit Scale version 1.1
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DOI：
10.1093/annonc/mdx310
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发表时间：
2017-10-01
影响因子：
50.5
通讯作者：
de Vries, E. G. E.
中科院分区：
文献类型：
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作者：
Cherny, N. I.;Dafni, U.;de Vries, E. G. E.
背景资料：ESMO临床获益幅度量表（ESMO-MCBS）版本1.0（v1.0）于2015年5月发布，是评估新癌症治疗临床获益幅度的经验证和可重现工具的第一个版本。ESMO-MCBS的设计是一个动态的工具，有计划的修订和更新的基础上，认识到扩大的需求和缺点，因为上次review.Methods确定：ESMO-MCBS的修订过程包括九个步骤的过程：仔细审查的批评和建议，并确定问题的应用v1.0;提出并评估解决已发现的不足之处的解决方案;对解决方案进行实地测试;编写接近最终的修订版本，供ESMO教员和准则委员会成员进行合理性同行审查;根据同行审查进行合理性修正; ESMO-MCBS工作组和ESMO执行委员会成员进行接近最终的审查;最终修正;结果：提出了12个供修订或修正的问题供审议;针对8个已查明的缺陷拟订了拟议修正案。拟议的修正案分为结构性、技术性、免疫疗法引发或细微差别。所有修正案进行了现场测试，在广泛的研究比较评分与ESMO-MCBS版本1.0和版本1.1（v1.1）。结论：ESMO-MCBS版本1.1包含10个修订版，将允许单组研究的评分。评分保持非常稳定; v1.1中的修订仅改变了118项比较研究中12项的评分，并促进了单组研究的评分。
Background: The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified since the last review.Methods: The revision process for the ESMO-MCBS incorporates a nine-step process: Careful review of critiques and suggestions, and identification of problems in the application of v1.0; Identification of shortcomings for revision in the upcoming version; Proposal and evaluation of solutions to address identified shortcomings; Field testing of solutions; Preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and Guidelines Committee; Amendments based on peer review for reasonableness; Near-final review by members of the ESMO-MCBS Working Group and the ESMO Executive Board; Final amendments; Final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.Results: Twelve issues for revision or amendment were proposed for consideration; proposed amendments were formulated for eight identified shortcomings. The proposed amendments are classified as either structural, technical, immunotherapy triggered or nuanced. All amendments were field tested in a wide range of studies comparing scores generated with ESMO-MCBS v1.0 and version 1.1 (v1.1).Conclusions: ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.