TY - JOUR
T1 - Considerations in the development of circulating tumor cell technology for clinical use
AU - Parkinson, David R.
AU - Dracopoli, Nicholas
AU - Petty, Brenda G.
AU - Compton, Carolyn
AU - Cristofanilli, Massimo
AU - Deisseroth, Albert
AU - Hayes, Daniel F.
AU - Kapke, Gordon
AU - Kumar, Prasanna
AU - Lee, Jerry S H
AU - Liu, Minetta C.
AU - McCormack, Robert
AU - Mikulski, Stanislaw
AU - Nagahara, Larry
AU - Pantel, Klaus
AU - Pearson-White, Sonia
AU - Punnoose, Elizabeth A.
AU - Roadcap, Lori T.
AU - Schade, Andrew E.
AU - Scher, Howard I.
AU - Sigman, Caroline C.
AU - Kelloff, Gary J.
PY - 2012/7/2
Y1 - 2012/7/2
N2 - 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 development-analytical 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).
AB - 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 development-analytical 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).
KW - Analytical validation
KW - Biomarker qualification
KW - Circulating tumor cells
KW - Clinical validation
KW - Oncologic drug development
KW - Predictive biomarker
KW - Prognostic biomarker
UR - http://www.scopus.com/inward/record.url?scp=84863100828&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84863100828&partnerID=8YFLogxK
U2 - 10.1186/1479-5876-10-138
DO - 10.1186/1479-5876-10-138
M3 - Article
C2 - 22747748
AN - SCOPUS:84863100828
SN - 1479-5876
VL - 10
JO - Journal of Translational Medicine
JF - Journal of Translational Medicine
IS - 1
M1 - 138
ER -