Biomarkers, or biological markers, are defined in various ways. Some define
it as ‘a biologic feature that can be used to measure the presence or progress of
disease or the effects of treatment. One goal of biomarker usage in clinical research
is to expedite the drug development process to produce drug therapies as efficiently
as possible, while maintaining the safety profile. Biomarkers have been used for
decades, from monitoring blood pressure to lipid levels. Tumor biomarkers represent
an effective tool for tumor diagnosis, treatment, prognosis, and therapeutic monitoring.
Ideally, the use of biomarkers in early trials would help predict the likelihood
of success or failure of a drug in efficacy trials. Biomarkers can predict drug
efficacy more quickly than conventional clinical end points; they hold the potential
to substantially accelerate product development in certain disease. This review is mainly focused
on the role biomarkers in cancer drug development process and the literature was collected
from articles published in PUBMED, Medline, and the Cochrane Database of Systemic
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