Online Program

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Wednesday, September 25
Wed, Sep 25, 2:45 PM - 4:00 PM
Thurgood Marshall East
Statistical Considerations and Methods: Precision Medicine Clinical Trials for Therapy Agnostic to Cancer Site

Review Experience in Tissue Agnostic Indications (300987)

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Xiaoping Jiang, FDA 
Yuan-li Shen, FDA 
*Vivian Yuan, FDA 

Keywords: tissue agnostic, oncology

As advances in genomics and precision medicine continue to be made, FDA has been taking new developments into account as it considers what constitutes a “disease or condition.” Tumor-agnostic treatment represents a new way of thinking about how cancer is treated that is quite different from how treatment plans have been developed in the past. In this talk we discuss the design and analyses of clinical trials for drug development based on biomarkers that are agnostic to tissue types. Two case studies will be presented.