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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorGyawali, B.
dc.contributor.authorde Vries, Elisabeth
dc.contributor.authorDafni, U.
dc.contributor.authorAmaral, T.
dc.contributor.authorBarriuso, J.
dc.contributor.authorBogaerts, J.
dc.contributor.authorTabernero Caturla, Josep
dc.date.accessioned2021-12-02T12:37:25Z
dc.date.available2021-12-02T12:37:25Z
dc.date.issued2021-06
dc.identifier.citationGyawali B, de Vries EGE, Dafni U, Amaral T, Barriuso J, Bogaerts J, et al. Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring. ESMO Open. 2021 Jun;6(3):100117.
dc.identifier.issn2059-7029
dc.identifier.urihttp://hdl.handle.net/11351/6642
dc.descriptionClinical trial design; Clinical trial implementation; Clinical trial reporting
dc.description.abstractBackground The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, implementation, or data analysis and identify shortcomings in need of amendment. Methods As part of a refinement of the ESMO-MCBS, we reviewed trial design, implementation, and data analysis issues that could bias the results. For each issue of concern, we reviewed the ESMO-MCBS v1.1 approach against standards derived from Helsinki guidelines for ethical human research and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Food and Drugs Administration, the European Medicines Agency, and European Network for Health Technology Assessment. Results Six design, two implementation, and two data analysis and interpretation issues were evaluated and in three, the ESMO-MCBS provided adequate protections. Seven shortcomings in the ability of the ESMO-MCBS to identify and address bias were identified. These related to (i) evaluation of the control arm, (ii) crossover issues, (iii) criteria for non-inferiority, (iv) substandard post-progression treatment, (v) post hoc subgroup findings based on biomarkers, (vi) informative censoring, and (vii) publication bias against quality-of-life data. Conclusion Interpretation of the ESMO-MCBS scores requires critical appraisal of trials to understand caveats in trial design, implementation, and data analysis that may have biased results and conclusions. These will be addressed in future iterations of the ESMO-MCBS.
dc.language.isoeng
dc.publisherBMJ
dc.relation.ispartofseriesESMO Open;6(3)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectCàncer - Tractament
dc.subjectAssaigs clínics - Disseny
dc.subject.meshNeoplasms
dc.subject.mesh/drug therapy
dc.subject.meshResearch Design
dc.subject.meshMedical Oncology
dc.titleBiases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1016/j.esmoop.2021.100117
dc.subject.decsneoplasias
dc.subject.decs/farmacoterapia
dc.subject.decsdiseño de la investigación
dc.subject.decsoncología médica
dc.relation.publishversionhttps://doi.org/10.1016/j.esmoop.2021.100117
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Gyawali B] Department of Oncology, Queen’s University, Kingston, Ontario, Canada. Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada. Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada. [de Vries EGE] Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. [Dafni U] Laboratory of Biostatistics, School of Health Sciences, National and Kapodistrian University of Athens, Athens. Frontier Science Foundation-Hellas, Athens, Greece. [Amaral T] Skin Cancer Center, Department of Dermatology, Eberhard Karls University, Tuebingen, Germany. [Barriuso J] The Christie NHS Foundation Trust and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. [Bogaerts J] European Organisation for Research and Treatment of Cancer, Brussels, Belgium. [Tabernero J] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IO-Quiron, Barcelona, Spain
dc.identifier.pmid33887690
dc.identifier.wos000663044500017
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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