Chapter title |
Efficient, Adaptive Clinical Validation of Predictive Biomarkers in Cancer Therapeutic Development
|
---|---|
Chapter number | 6 |
Book title |
Advances in Cancer Biomarkers
|
Published in |
Advances in experimental medicine and biology, January 2015
|
DOI | 10.1007/978-94-017-7215-0_6 |
Pubmed ID | |
Book ISBNs |
978-9-40-177214-3, 978-9-40-177215-0
|
Authors |
Robert A. Beckman, Cong Chen |
Abstract |
Predictive biomarkers, defined as biomarkers that can be used to identify patient populations who will optimally benefit from therapy, are an important part of the future of oncology. They have the potential to reduce the size and cost of clinical development programs for oncology therapy, while increasing their probability of success and the ultimate value of cancer medicines. But predictive biomarkers do not always work, and under these circumstances they add cost, complexity, and time to drug development. This chapter describes Phase 2 and 3 development methods which efficiently and adaptively evaluate the ability of the biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it is actually predictive. This allows clinical cancer drug developers to manage uncertainty in the validity of biomarkers, leading to maximal value for predictive biomarkers and their associated oncology therapies. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 12 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 3 | 25% |
Unspecified | 2 | 17% |
Student > Master | 2 | 17% |
Researcher | 2 | 17% |
Student > Bachelor | 1 | 8% |
Other | 0 | 0% |
Unknown | 2 | 17% |
Readers by discipline | Count | As % |
---|---|---|
Unspecified | 2 | 17% |
Biochemistry, Genetics and Molecular Biology | 2 | 17% |
Computer Science | 2 | 17% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 8% |
Psychology | 1 | 8% |
Other | 2 | 17% |
Unknown | 2 | 17% |