FDA guidance and regulatory experience on enrichment design
*Yuan Li Shen, FDA/CDER/OTS/OB  *Raji Sridhara, FDA/CDER/OTS/OB 


In the era of personalized medicine and targeted therapy, it is important that the drug development process is conducted efficiently. It is therefore essential to adapt during trial based on the interim results observed to stop for futility, efficacy or modify the study by increasing sample size, or focus the remainder of the study on a subpopulation. We will present the FDA guidance on enrichment design and regulatory experience in these type of adaptive designs.