Surrogate Endpoints Table and Type C Meetings for Novel Surrogate Endpoints

Surrogate endpoints (SEs) can be used instead of clinical outcomes in some clinical trials when the clinical outcomes might take a very long time to study, or in cases where the clinical benefit of improving the SE, such as controlling blood pressure, is well understood.  The use of SEs for certain clinical studies has helped to expedite drug development.

To enhance the use of SEs in drug development and expand existing transparency initiatives, the FDA has taken two steps:  

• CDER has published a list of surrogate endpoints (SEs) which were the basis of approval or licensure (as applicable) of a drug or biological product for both accelerated and traditional approval on its website in response to the 21st Century Cures Act legislation, Section 3011.

• The FDA is accepting requests for Type C IND meetings focused on potential novel surrogate endpoints that may be used in drug development programs. In these meetings, participants will discuss the use of biomarkers as a new SE that has never been used as the primary basis for product approval in the proposed context of use. These meetings will allow the FDA to provide advice regarding the proposed biomarker as a new SE to support accelerated or traditional approval. The FDA has created a web page that describes the meetings and provide sponsors with resources for preparing a request for the meeting. The meeting requests are part of the FDA’s PDUFA VI commitments to expediting drug development. This communications plan describes how CDER will inform industry of these new resources. 

For additional information, visit Surrogate Endpoint Resources for Drug and Biologic Development.