Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
Rodríguez, Adela (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas)
Esposito, Francis (Hospital Clínic i Provincial de Barcelona)
Oliveres, Helena (Hospital Clínic i Provincial de Barcelona)
Torres, Ferran (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i Medicina Preventiva i Salut Pública)

Data:	2021
Resum:	The approval of a new drug for cancer treatment by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is based on positive, well-designed randomized phase III clinical trials (RCTs). However, not all of them are analyzed to support the recommendations. For this reason, there are different scales to quantify and evaluate the quality of RCTs and the magnitude of the clinical benefits of new drugs for treating solid tumors. In this review, we discuss the value of the progression-free survival (PFS) as an endpoint in RCTs and the concordance between it and the overall survival (OS) as a measure of the quality of clinical trial designs. We summarize and analyze the different scales to evaluate the clinical benefits of new drugs such as the The American Society of Clinical Oncology value framework (ASCO-VF-NHB16) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the concordance between them, focusing on metastatic colorectal cancer (mCRC). We propose several definitions that would help to evaluate the quality of RCT, the magnitude of clinical benefit and the appropriate approval of new drugs in oncology.
Ajuts:	Instituto de Salud Carlos III PI13/ 01728 Instituto de Salud Carlos III PI19/00740
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Quality randomized studies ; ESMO-MCBS ; Drug approval
Publicat a:	Journal of clinical medicine, Vol. 10 Núm. 4 (2021) , p. 746, ISSN 2077-0383

DOI: 10.3390/jcm10040746
PMID: 33668473

14 p, 375.3 KB

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