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Abstract:
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The effectiveness of new drugs for regulatory approvals can be derived based on the clinical outcomes, as well as established surrogate endpoints, according to the 1962 amendment to the Federal Food, Drug, and Cosmetic Act. As of today, very few surrogate endpoints have been established through formal regulatory approval process in oncology. We will present a recent surrogacy evaluation study which led to FDA endorsement of complete response at 30 months as an appropriate surrogate endpoint of progression-free survival in first line follicular lymphoma clinical trials. The study was conducted by the FLASH group, an academic collaboration, based on individual patient data from a large collection of randomized clinical trials. The surrogacy was measured by meta-analytic methods developed by Burzykowski et al (Journal of the Royal Statistical Society: Series A 2004) and Sargent et al (Journal of Clinical Oncology 2005 & 2007). We will discuss our experiences and interactions with regulatory agents from both US and Europe regarding study design, pre-specified analysis strategies, and qualification criteria as well as the review process of the final results.
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