Abstract:

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 Reviews.

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