Considerations in the development of circulating tumor cell technology for clinical use.
Standard
Considerations in the development of circulating tumor cell technology for clinical use. / Parkinson, David R; Dracopoli, Nicholas; Petty, Brenda Gumbs; Compton, Carolyn; Cristofanilli, Massimo; Deisseroth, Albert; Hayes, Daniel F; Kapke, Gordon; Kumar, Prasanna; Lee, Jerry Sh; Liu, Minetta C; McCormack, Robert; Mikulski, Stanislaw; Nagahara, Larry; Pantel, Klaus; Pearson-White, Sonia; Punnoose, Elizabeth A; Roadcap, Lori T; Schade, Andrew E; Scher, Howard I; Sigman, Caroline C; Kelloff, Gary J.
in: J TRANSL MED, Jahrgang 10, 2012, S. 138.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
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 Gumbs
AU - Compton, Carolyn
AU - Cristofanilli, Massimo
AU - Deisseroth, Albert
AU - Hayes, Daniel F
AU - Kapke, Gordon
AU - Kumar, Prasanna
AU - Lee, Jerry Sh
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
Y1 - 2012
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 - Humans
KW - Tumor Markers, Biological
KW - Neoplastic Cells, Circulating
KW - Humans
KW - Tumor Markers, Biological
KW - Neoplastic Cells, Circulating
U2 - 10.1186/1479-5876-10-138
DO - 10.1186/1479-5876-10-138
M3 - SCORING: Journal article
VL - 10
SP - 138
JO - J TRANSL MED
JF - J TRANSL MED
SN - 1479-5876
ER -