Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs.

ABSTRACT:

Background

In July 2018, the FDA first published a table listing all surrogate measures that it has used, and may accept for future use, in regulatory approval. However, the strength of surrogacy for those measures was not formally assessed. Using the case example of breast cancer, we aimed to evaluate the strength of correlation of surrogate measures listed in the FDA's Table with overall survival.

Methods

This cross-sectional study of the FDA's Table of Surrogate Endpoints was conducted in May 2019. All surrogate measures listed in the FDA table as appropriate for accelerated or regular approval for breast cancer were extracted. We identified studies evaluating the correlation of treatment benefit in the surrogate with treatment benefit in overall survival and extracted re

SUBMITTER: Gyawali B 

PROVIDER: S-EPMC7201012 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature