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The use of circulating biomarkers in early clinical trials in patients with cancer

Lookup NU author(s): Dr Manolo D'Arcangelo, Dr Jane Margetts, Professor Alastair GreystokeORCiD


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The development of targeted therapies has changed the approach to early oncological clinical trial design. Identification of patient populations most likely to derive benefit and the biologically effective dose are now as important as determination of the maximum tolerated dose. Completion of the 'pharmacological audit trail' highlights drugs most likely to progress through to license, so resources can be allocated appropriately. Key to the success of this changing model is the validation/qualification of circulating biomarkers. These might provide a readily accessible and dynamic picture of drug effect, tumor response and toxicity with minimum risk to patients. This review article examines circulating biomarkers currently used in early oncological clinical trials. It considers the evidence for their employment, limitations and challenges for future development.

Publication metadata

Author(s): Margetts J; Greystoke A; D'Arcangelo M

Publication type: Review

Publication status: Published

Journal: Biomarkers in Medicine

Year: 2015

Volume: 9

Issue: 10

Pages: 1011-1023

Print publication date: 01/01/2015

Acceptance date: 01/01/1900

ISSN (print): 1752-0363

ISSN (electronic): 1752-0371



DOI: 10.2217/bmm.15.51