Summary

This article discusses end points and novel clinical trial design in the era of targeted therapies, and the need to accelerate the drug development process so that the right therapies can quickly be delivered to the right patients with gastrointestinal cancers. The increasing number of novel targeted therapies available for testing for cancers, including those of the gastrointestinal tract, requires new approaches to clinical trials to identify promising agents for Phase 3 testing—particularly with respect to end points and trial designs.