Development and Application of Surrogate Endpoints in FDA's Drug Review Process / 中国药学杂志

ABSTRACT

OBJECTIVE: To figure out the regulatory models and concepts of FDA in drug review process that promotes surrogate endpoints development. METHODS: This paper made a thorough research to the FDA regulations, guidance documents and guidelines and literatures, and through historical retrospective of surrogate endpoints used in clinical drug trials and regulatory acceptance, interpretation of FDA's established development model in scientific use of surrogates, combined with the status quo surrogate endpoints in the field of serious diseases as cancer, AIDS, diabetes. RESULTS AND CONCLUSION: Then conclusion of FDA's experience in promoting regulation and utility of surrogate endpoints is summed up, including the development of guidelines to promote common understanding of specific use of surrogates; combining a variety of programs promote the development of surrogate endpoints; and using a risk-based classification in favor of the allocation of resources.