Cited by 641Statistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeMeta-analysis and systematic reviews

ESMO-magnitude of clinical benefit scale version 1.1

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Cherny, N.I., Dafni, U., Bogaerts, J., Latino, N.J., Pentheroudakis, G., Douillard, J.-Y., Tabernero, J., Zielinski, C. +2 more·2017·Annals of Oncology

Abstract

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.

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Authors
Cherny, N. I., Dafni, U., Bogaerts, J., Latino, N. J., Pentheroudakis, G., Douillard, J.-Y., Tabernero, J., Zielinski, C., Piccart, M. J., & de Vries, E. G. E.
Affiliations
  • Shaare Zedek Medical Center (IL)
  • National and Kapodistrian University of Athens (GR)
  • European Organisation for Research and Treatment of Cancer (NL)
  • European Society for Medical Oncology (CH)
  • University Hospital of Ioannina (GR)
  • Vall d'Hebron Hospital Universitari (ES)
  • Medical University of Vienna (AT)
  • Université Libre de Bruxelles (BE)
Corresponding author
Cherny, N.I.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2017-10
Volume
28
Issue
10
Pages
2340-2366
ISSN
0923-7534 (ISSN-L)
OpenAlex
W2753603515
Cited by
641
References
47
Citations by year
2026: 30 · 2025: 54 · 2024: 84 · 2023: 83 · 2022: 77 · 2021: 99 · 2020: 79 · 2019: 74 · 2018: 47 · 2017: 11 · 2016: 1
FWCI
40.13
Type
journal article
Language
en
Open access
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
  • Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Funders
ESMO
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
ESMO Magnitude of Clinical Benefit Scale, ESMO-MCBS, cancer therapy, scale revision, single-arm studies, immunotherapy, score stability
MeSH terms
Clinical Trials as Topic, Humans, Medical Oncology, Neoplasms, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Biostatistics

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