2026-04-17T03:11:33Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/66422024-12-13T10:07:08Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Gyawali, B. author Dafni, U. author Amaral, T. author Barriuso, J. author Bogaerts, J. author Tabernero Caturla, Josep author de Vries, Elisabeth author 2021-12-02T12:37:25Z 2021-12-02T12:37:25Z 2021-06 Diseño de ensayos clínicos; Implementación de ensayos clínicos; Informes de ensayos clínicos Clinical trial design; Clinical trial implementation; Clinical trial reporting Disseny d'assaigs clínics; Implementació d'assaigs clínics; Informes d'assaigs clínics Background 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. None declared. http://hdl.handle.net/11351/6642 Càncer - Tractament Assaigs clínics - Disseny DISEASES::Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Methods::Research Design DISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical Oncology ENFERMEDADES::neoplasias Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos::diseño de la investigación DISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médica 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