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Searching For Surrogate Endpoints Requires Teamwork

 
• By Cathy Dombrowski

Discussions between FDA and researchers during a workshop on the fatty liver conditions NAFLD/NASH clarified the status of potential surrogate endpoints for clinical trials, but indicated that much work remains to be done to ready the various options for use – and that will likely need to be a joint effort.

Collaboration among sponsors is the most likely path forward to finding surrogate endpoints that reflect clinically meaningful benefits for patients with non-alcoholic fatty liver disease (NAFLD) and its progressive form, non-alcoholic steatohepatitis (NASH), which can then lead to cirrhosis and eventually the need for a liver transplant or death.

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