|
|||||
|
|
Considerations in the development of circulating tumor cell technology for clinical use |
|
| Authors: | David R Parkinson Nicholas Dracopoli Brenda Gumbs Petty Carolyn Compton Massimo Cristofanilli Albert Deisseroth Daniel F Hayes Gordon Kapke Prasanna Kumar Jerry SH Lee Minetta C Liu Robert McCormack Stanislaw Mikulski Larry Nagahara Klaus Pantel Sonia Pearson-White Elizabeth A Punnoose Lori T Roadcap Andrew E Schade Howard I Scher Caroline C Sigman Gary J Kelloff |
| Affiliation: | 1. New Enterprise Associates, Menlo Park, CA, 94025, USA 2. Johnson &Johnson, Radnor, PA, 19087, USA 3. CCS Associates, Mountain View, CA, 94043, USA 4. Critical Path Institute, Tucson, AZ, 85718, USA 5. Fox Chase Cancer Center, Philadelphia, PA, 19111, USA 6. Center for Drug Evaluation Research, US Food & Drug Administration, Silver Spring, MA, 20903, USA 7. University of Michigan, Ann Arbor, MI, 48109, USA 8. Covance Genomic Lab, Covance Central Labs, Seattle, WA, 98382, USA 9. Daiichi-Sankyo Pharma Development, Edison, NJ, 08837, USA 10. National Cancer Institute, Bethesda, MA, 20892, USA 11. Georgetown University, Washington, DC, 20007, USA 12. Veridex, LLC, Raritan, NJ, 08869, USA 13. EMD Serono, Rockland, MA, 02370, USA 14. University Medical Center Hamburg-Eppendorf, 20246, Hamburg, Germany 15. Foundation for the National Institutes of Health, Bethesda, MA, 20814, USA 16. Genentech, South San Francisco, CA, 94080, USA 17. GlaxoSmithKline, Collegeville, PA, 19426, USA 18. Eli Lilly and Company, Indianapolis, IN, 46285, USA 19. Memorial Sloan-Kettering Cancer Center, New York, NY, 10065, USA |
| Abstract: | ABSTRACT: This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker developmentanalytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI). |
| Keywords: | |
| 本文献已被 PubMed SpringerLink 等数据库收录！ | |