Dossier 20 – Évaluation de la pertinence clinique

1 Introduction

2 Pertinence du comparateur

3 Pertinence clinique du critère de jugement

Références

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Références

     

[1] Hilal T, Gonzalez-Velez M, Prasad V. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration. JAMA Intern Med 2020;180:1108–15 10.1001/jamainternmed.2020.2250 [32539071]

[2] Hilal T, Sonbol MB, Prasad V. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration. JAMA Oncol 2019;5:887–92 10.1001/jamaoncol.2019.0167 [31046071]

[3] Mohyuddin GR, Koehn K, Sborov D, et al. Quality of control groups in randomised trials of multiple myeloma enrolling in the USA: a systematic review. The Lancet Haematology 2021;8:e299-e304 10.1016/S2352-3026(21)00024-7