Future Approaches to Precision Oncology-Based Clinical Trials.

The last 2 decades have seen a rapid advance of the precision oncology paradigm-from its early singular successes to becoming the prevailing model of cancer therapy. As the treatment of cancer moves away from traditional chemotherapy, so too will oncology clinical trials have to move away from the traditional model of phase I to phase III progression of drug development. Achieving this goal of individualized care will involve a concerted effort by the entire cancer care community to fundamentally change the design and implementation of oncology clinical trials. We envision that the next 2 decades will be a period of evolution in precision oncology clinical trials through scientific and technologic advances, transformation of clinical trial infrastructure, and changes in the kind of evidence required for regulatory approval.