FDA Proposes Special Meetings to Discuss New Surrogate Endpoints
[Posted on: Thursday, July 26, 2018] This week FDA released a list of all surrogate endpoints used for approval of drugs and created a special meeting specifically to discuss creation of new surrogate endpoints. The list of surrogate endpoints includes more than 100 drug and biologic products approved by FDA over the last 10-15 years and cover practically all major indications. A review of the list shows several surrogate endpoints that have been used for multiple drug approvals, particularly in cancers but also shows several that have been used one or few approvals. The list is expected to highlight the possibilities for FDA acceptable endpoints, but the intent is to encourage discussions with FDA prior to using any of these in new drug projects. Also, surrogate endpoints that may have been acceptable in the past but are no longer acceptable by FDA are not included. Sponsor are also encouraged to develop new surrogate endpoints. For that FDA created a special Type C meeting to discuss new surrogate endpoints. Requests for these Type C meetings can be made at any time in the development of a drug once preliminary hypothesis building clinical data becomes available. To request a Type C meeting to discuss new surrogate endpoints, sponsors will need to submit a full meeting information package describing background information to support the rationale of using a new surrogate endpoint (SE) as a primary endpoint, relationship of SE to the mechanism of action, clinical relevance of the SE, consistence, reliability, and predictive value of the SE. Since this is a Type C meeting, it should follow similar timelines and logistics as other Type C meetings. The process seems similar to the one available over the years to discuss new endpoints with FDA, however, the details of the instructions and the intent should be welcome by all developers looking towards new SEs for their products. Its not a new process but a nice repackaging of the existing processes that should increase the visibility of the resources available at the Agency.
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