Predictive Biomarker
A Predictive Biomarker is a biomarker that can identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or environmental agent.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Predictive_marker Retrieved:2021-12-14.
- A predictive marker is a particular protein or gene that indicates sensitivity or resistance to a specific therapy. The use of predictive markers is becoming increasingly relevant in cancer therapy as it allows for better identification of patients who will respond positively to the therapy. In the clinical setting, predictive markers are limited to use in breast cancer. Expression of estrogen and progesterone receptors can determine the benefits of hormone therapy, whilst the benefit of treating breast cancer patients with herceptin (Trastuzumab) is determined by the expression of HER2. There are many advantages to utilizing a predictive marker in cancer therapy including better patient management minimizing unnecessary suffering from side effects with ultimately the wrong treatment choice, reducing loss of precious time whilst determining whether a therapy will provide any benefit, and a reduction in cost to both the patient and the wider health community.
2020
- https://www.ncbi.nlm.nih.gov/books/NBK402283/
- QUOTE: ... A predictive biomarker is a biomarker used to identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or environmental agent. The response could be a symptomatic benefit, improved survival, or an adverse effect.
A familiar example of use of a predictive biomarker in medical product development is predictive enrichment of the study population for a randomized controlled clinical trial of an investigational therapy, in which the biomarker is used either to select patients for participation or to stratify patients into biomarker positive and biomarker negative groups, with the primary endpoint being the effect in the biomarker positive group (U.S. Food and Drug Administration 2012). If the biomarker is in fact predictive of a favorable outcome, then the effect of the investigational therapy compared to a control therapy (including no therapy) will be greater (or present at all) in patients with the biomarker or some level of the biomarker. When only a small fraction of the patients who receive the investigational therapy are expected to show a meaningful effect, identification of that small group using a predictive biomarker is critical to the feasibility of demonstrating the intervention’s effectiveness (Betensky et al. 2002; Maitournam and Simon 2005). The notion of a predictive biomarker applies to a wide variety of interventions, including drugs, biologics, medical devices or procedures, and behavioral or dietary modifications for treatment or prevention of diseases or conditions. ...
- QUOTE: ... A predictive biomarker is a biomarker used to identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or environmental agent. The response could be a symptomatic benefit, improved survival, or an adverse effect.
2011
- (Rejto, 2011) ⇒ Paul Rejto. year::2011]]). “Knowledge Discovery and Data Mining in Pharmaceutical Cancer Research.” In: Proceedings of the 17th ACM SIGKDD International Conference on Knowledge Discovery and Data Mining (KDD-2011). doi:10.1145/2020408.2020539
- QUOTE: Biased and unbiased approaches to develop predictive biomarkers of response to drug treatment will be introduced and their utility demonstrated for cell cycle inhibitors. Opportunities to leverage the growing knowledge of tumors characterized by modern methods to measure DNA and RNA will be shown, including the use of appropriate preclinical models and selection of patients. ...
2010
- (Mandrekar & Sargent, 2010) ⇒ Sumithra J. Mandrekar, and Daniel J. Sargent. (2010). “Predictive Biomarker Validation in Practice: Lessons from Real Trials.” In: Clinical Trials, (7)5
- ABSTRACT: With the advent of targeted therapies, biomarkers provide a promising means of individualizing therapy through an integrated approach to prediction using the genetic makeup of the disease and the genotype of the patient. Biomarker validation has therefore become a central topic of discussion in the field of medicine, primarily due to the changing landscape of therapies for treatment of a disease and these therapies purported mechanism(s) of action. ... There is no one size fits all solution to predictive biomarker validation.