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Call for Comment - Surrogate Endpoints Virtual Summit Executive Summary

By SITC Advocacy posted 07-12-2024 00:00

  

The Society for Immunotherapy of Cancer (SITC) is pleased to announce the publication of a comprehensive summary on the Surrogate Endpoints Virtual Summit, which was held on April 5, 2024.

Surrogate endpoints have been instrumental for the advancement of immunotherapy, including dozens of approvals for a multitude of modalities across various disease states. These approvals are often facilitated through the use of endpoints that serve as surrogates for “gold standard” clinical trial metrics. Further investigation and identification of effective novel surrogate endpoints is critical to increase the quality, quantity and speed at which novel therapies can enter the clinic. As such, the SITC Biomarkers Committee and Regulatory Subcommittee held a multi-stakeholder virtual summit on this topic to characterize challenges facing surrogate endpoint advancement and potential field-wide solutions that can safely expedite novel clinical agents.

We invite feedback from the community on the proposed takeaways and next steps from the summit via a short survey. The program organizers will use this feedback to work with regulators and relevant stakeholders for future publications and meetings.

#Policy

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