Evaluating the evidence behind the surrogate measures included in the FDAs table of surrogate endpoints as supporting approval of cancer drugs

摘要

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.