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.

Fiche publication

Date publication

juin 2021

Journal

ESMO open

Auteurs

Membres identifiés du Cancéropôle Est :
Dr AMARAL Teresa Maria

Tous les auteurs :
Gyawali B, de Vries EGE, Dafni U, Amaral T, Barriuso J, Bogaerts J, Calles A, Curigliano G, Gomez-Roca C, Kiesewetter B, Oosting S, Passaro A, Pentheroudakis G, Piccart M, Roitberg F, Tabernero J, Tarazona N, Trapani D, Wester R, Zarkavelis G, Zielinski C, Zygoura P, Cherny NI

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/33887690

Résumé

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.