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Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials

Authors Van Heertum R, Scarimbolo R, Ford R, Berdougo E, O'Neal M

Received 29 April 2015

Accepted for publication 14 July 2015

Published 11 September 2015 Volume 2015:9 Pages 5215—5223


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Professor Shu-Feng Zhou

Ronald L Van Heertum, Robert Scarimbolo, Robert Ford, Eli Berdougo, Michael O’Neal

BioClinica Inc, Princeton, PA, USA

Abstract: In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Keywords: companion diagnostics, molecular imaging, oncology trials, personalized medicine, diagnostic assays

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