SLAS 2019 Americas Sample Management Symposium

This talk will review complexity of CAR T cell clinical trials, with focus on the biomarker and exploratory research that is inherent to such trials and sampling required to support such research.  In the context of allogeneic CAR T trials, there is interest in understanding patient, tumor and T cell donor attributes that are associated with efficacy or safety.  Thus sampling and research plans are quite complex.  In trials with complex biomarker endpoints, the ability to achieve a globally acceptable informed consent is a challenge, and one that must be addressed so as to preserve the ability to generate robust data across the entire trial population.  The ICH E18 Guidance was developed in part to harmonize guidance and expectations on the conduct of genomic research within clinical trials.   Some elements of this Guidance will be discussed.