Recent clinical trials aim to identify biomarkers of response and resistance to the agents under investigation. This can require tissue samples that will not necessarily provide a direct benefit to the patient. Given the risks associated with any procedure, not every patient is willing to undergo a research biopsy. In this article, Olson et al. present the rationale to establish when research biopsies should be mandatory and to ensure that clinical trials are designed with scientific and ethical rigor.
- Erin M. Olson
- Nancy U. Lin
- Eric P. Winer