TL11: Selection and Validation of Biomarkers and Surrogate Endpoints
View Presentation *Abel T Eshete, FDA Keywords: 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC