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A prognostic biomarker provides information about the patients overall outcome, regardless of any treatment or therapeutic intervention. [6] One example of a prognostic biomarkers in clinical research, is the use of mutated PIK3CA in the study of metastatic breast cancer.
Complex organ functions or general characteristic changes in biological structures can also serve as biomarkers. Although the term biomarker is relatively new, biomarkers have been used in pre-clinical research and clinical diagnosis for a considerable time. [4] For example, body temperature is a well-known biomarker for fever.
In clinical trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. The National Institutes of Health (USA) defines surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint ...
Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ...
Biomarker discovery is a medical term describing the process by which biomarkers are discovered. Many commonly used blood tests in medicine are biomarkers. There is interest in biomarker discovery on the part of the pharmaceutical industry; blood-test or other biomarkers could serve as intermediate markers of disease in clinical trials, and as possible drug targets.
A combination of two types of therapeutic agents selectively killed breast cancer cells in a clinical trial, offering hope for a new treatment for triple-negative breast cancer.
3. "The current standard for treating patients with clinical stage 2 or 3 triple-negative breast cancer is to administer chemotherapy in addition to immunotherapy prior to surgery. This ...
However, successful biomarker surrogates could save substantial time, effort, and money if failing drugs could be eliminated from the development pipeline before being brought to clinical trials. Some ideal characteristics of surrogate endpoint biomarkers include: [43] [44] Biomarker should be involved in process that causes the cancer
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