TL11: Selection and Validation of Biomarkers and Surrogate Endpoints
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*Abel T Eshete, FDA 


The safety and efficacy of a new drug is commonly evaluated using a predefined clinical outcome. The outcome of interest could be easy to assess or might require invasive surgical procedures and also might take a long time to manifest. Therefore, in the case of difficult to assess clinical outcomes, identifying a Biomarker that can be predictive of the clinical outcome while at the same time can be measured earlier and easier becomes paramount. The Biomarker could serves as a surrogate endpoint after it is properly validated. The validation process is a coordinate endeavor of statisticians and medical scientists. It is clear that the use of surrogate endpoints saves time and resources through a reduction in the duration of trials. This could potentially reduce overall costs for drug research and development thereby allowing for improved access of drugs for patients in a timely manner.