[ Title ]
- Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials
[ Journal ]
- DRUG DESIGN DEVELOPMENT AND THERAPY
[ Author ]
- Van Heertum, RL Scarimbolo, R Ford, R Berdougo, E O'Neal, M
[ 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.
[ URL ]
- https://mail.google.com/mail/u/1/#inbox/1506e3c46a0c16a5