Patient stratification involves the use of biomarkers to create subsets within a patient population that provide more detailed information about how the patient will respond to a given drug. Stratification can be a critical component to transforming a clinical trial from a negative or neutral outcome to one with a positive outcome by identifying the subset of the population most likely to respond to a novel therapy.
Stratification biomarkers can be used to enrich a clinical trials population with one or more goals in mind including:
- Increasing the responder population
- Reducing the size, time & cost
- Improving overall results of your clinical trial
The use of even moderately effective biomarkers, e.g. 70% sensitivity and specificity, can dramatically improve outcome.
