03 Basket Trial Design Considerations and Innovations

Oregon Convention Center 

Precision medicine endeavors to conform therapeutic interventions to the individuals being treated and needs to account for the heterogeneity of treatment benefit among patients and patient subpopulations. In oncology, basket trials have emerged as a popular design to better address the goals of precision medicine that endeavors to test the effectiveness of a therapeutic strategy among patients defined by the presence of a particular biomarker target rather than cancer, where the evaluation of treatment effectiveness are conducted with respect to the "baskets" which represent a partition of the targeted patient population. These trials have unique statistical and design considerations. In this poster, we highlight how these considerations impact trial operating characteristics, can be leveraged to account for uncertainty in the design stage, and how to further improve efficiency through incorporation of interim monitoring strategies.