Open AccessPhase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
Author(s) -
Nader Sanai
Publication year - 2019
Publication title -
neurosurgery/neurosurgery online
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.485
H-Index - 34
eISSN - 1081-1281
pISSN - 0148-396X
DOI - 10.1093/neuros/nyz218
Subject(s) - medicine , clinical trial , drug development , intensive care medicine , phases of clinical research , drug , pharmacodynamics , oncology , pharmacokinetics , medical physics , pharmacology
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 clinical trial mechanism as well as its current and future applications within neurosurgical oncology.