FDA has published a table of surrogate endpoints which may be used by drug developers as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). This table reflects the requirement of the 21st Century Cures Act which demanded to publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product” for both accelerated and traditional approval provisions.
Therefore, this table provides drug developers with beneficial information on surrogate endpoints which may be adopted for conducting clinical trials after discussing them with FDA on the individual basis.
In concordance with the section 507(e)(9) of the Food, Drug, and Cosmetic (FD&C) Act, the term ‘surrogate endpoint’ means a marker, such as a laboratory measurement, radiographic image, physical sign, or another measure, that is not itself a direct measurement of clinical benefit, and
- ‘is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product;
- is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).’
This table includes surrogate endpoints which have already been used by sponsors as primary efficacy clinical trial endpoints for approval of NDAs and BLAs. However, endpoints which have never been used before but according to FDA may be appropriate for use as a primary efficacy clinical study endpoint for drug or biologic approval were also included. The acceptability of using each surrogate endpoint will be considered individually on a case-by-case basis. To sum up, these data were published by FDA in order to facilitate any further drug or biologics license applications.