Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm-Reference-Cited by-同舟云学术

Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm

Published:2024-08-12 Issue:1 Volume:14 Page:
ISSN:2044-5385
Container-title:Blood Cancer Journal
language:en
Short-container-title:Blood Cancer J.

Author:

Pawlyn Charlotte^ORCID,Schjesvold Fredrik H.^ORCID,Cairns David A.^ORCID,Wei L. J.,Davies Faith,Nadeem Omar,Abdulhaq Haifaa,Mateos Maria-Victoria^ORCID,Laubach Jacob^ORCID,Weisel Katja^ORCID,Ludwig Heinz^ORCID,Rajkumar S. Vincent^ORCID,Sonneveld Pieter^ORCID,Jackson Graham^ORCID,Morgan Gareth,Richardson Paul G.^ORCID

Funder

Dana Farber Cancer Institute, in part supported by the RJ Corman Multiple Myeloma Research Fund and an unrestricted grant from Oncopeptides AB

Publisher

Springer Science and Business Media LLC

Link

https://www.nature.com/articles/s41408-024-01109-4.pdf

Reference54 articles.

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharm Ther. 2001;69:89–95.

2. FDA-NIH Biomarker Working Group BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet] (National Institutes of Health (US) 2017).

3. EMA. Guideline on the clinical evaluation of anticancer medicinal products. 2019. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-anticancer-medicinal-products-man-revision-6_en.pdf. Accessed 9 January 2024.

4. US FDA. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry. 2018. Available from: https://www.fda.gov/media/71195/download. Accessed 9 January 2019.

5. Anderson KC, Auclair D, Adam SJ, Agarwal A, Anderson M, Avet-Loiseau H, et al. Minimal residual disease in myeloma: application for clinical care and new drug registration. Clin Cancer Res. 2021;27:5195–212.