Per the requirements in the 21st Century Cures Act, the FDA has published this month the first ever “Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure”. Surrogate endpoints (SEs, not to be confused with Substantial Equivalence for medical devices) are measures that are known to predict a clinical benefit that can be used as a substitute for measuring an outcome being studied in a clinical trial. They may be biomarkers measured in a laboratory, images produced by different techniques, physical clinical measurements, or any other predictive measure that is not itself a direct measurement of clinical benefit. The table is a reference guide that sponsors may use to facilitate discussions with their review division on their development programs. The list contains only SEs that are currently accepted for use, either because they were used for drugs that have already been approved or because they are listed in FDA guidance documents. SEs that were used in past programs but have been subsequently found unacceptable are not listed. The review divisions are open to discussions of novel SEs and new biomarkers. Sponsors interested in using a novel SE should schedule a Type C meeting with their review division, while those interested in new biomarkers should look into the Biomarker Qualification Program. The list is available as a downloadable file, and the agency (CBER and CDER) expects to update the SE list every 6 months. Read my other posts on MRD as a biomarker in leukemia trials and the PSTC/FNIH Kidney Safety biomarker.

Text Copyright © 2018 Katrina Rogers