Author:
Lengliné Etienne,Baba Joachim,de Boissieu Paul,Beaufils Alexandre,Desbiolles Alice,Diatta Thierno,Cochat Pierre,Chevret Sylvie
Reference31 articles.
1. U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry. 2018; published online Dec. https://www.fda.gov/media/71195/download.
2. Meaningful endpoints for therapies approved for hematologic malignancies;Smith;Cancer,2017
3. Agency E.M. Guideline on the Evaluation of Anticancer Medicinal Products in Man. http://www.ema.europa. eu/docs/en_GB/document_library/Scientific_guideline/2009/ 12/WC500017748.pd.
4. Progression-free survival as an end-point in solid tumours – Perspectives from clinical trials and clinical practice;Robinson;Eur J Cancer,2014
5. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review;Cordoba;BMJ,2010