Phase 0 clinical trial strategies for the neurosurgical oncologist

N Sanai - Neurosurgery, 2019 - journals.lww.com
In an era of escalating drug discovery costs, shifting priorities within the pharmaceutical
industry, and longstanding challenges in central nervous system drug delivery, surgical trials
offer an avenue to identify promising agents with demonstrable tumor penetration and
molecular effects. The rise of pharmacodynamic-and pharmacokinetic-driven clinical trials,
including phase 0 study designs, creates an opportunity for the neurosurgical oncologist to
engage drug development for brain tumor patients directly. Here, we review the phase 0 …