Regulatory Issues in the Co-Development of Oncology Drugs and Proteomic Tests: An Overview
Dave Li, Joseph Hackett, Maria M. Chan, Gene A. Pennello, Steve Gutman · Humana Press eBooks · 2007
In this article, we review some relevant issues in cancer proteomic biomarker development and validation for targeted cancer therapeutics with emphasis on the importance of developing a clearly stated intended use and indication for use, establishing a reliable laboratory measurement, using robust clinical study designs with representative patient populations and effective controls, and addressing issues of biological validations and potential bias associated with predictive biomarker validation.