Abstract
Precision Medicine has major implications not only for clinical practice but also for drug development and clinical trials. The implementation and conduct of a precision medicine clinical trial involves a complex coordination between multiple teams including clinical staff, laboratory staff, pharmacies, biostatisticians, regulatory experts, and bioinformatics. This real-time coordination offers an opportunity for advanced informatics solutions to facilitate the conduct of the clinical trial. This chapter will present an overview of how clinical trials within oncology are adapting to the precision medicine framework. Oncology provides a focused area where we have numerous examples of precision medicine trials, but most of the informatics solutions readily apply to other clinical domains. Following a description of the various clinical trial designs, we present a focused evaluation of the NCI-MPACT clinical trial and the GeneMed informatics system that was developed for the study.
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