Pre-stratify patients for smaller clinical trials

Clinical trials to establish the efficacy and safety of a new therapeutic represent a critical and hugely expensive stage in the drug development process. The cost of a single clinical trial patient enrollee is approximately $50,000, and the number of subjects needed to generate the data required for eventual market introduction is an important factor in overall development costs. One effective way to maximize the chances of success and significantly reduce the number of required trial enrollees is to pre-stratify potential subjects to ensure that those most likely to respond to the drug are included in the trial.

In addition, identification of biomarkers that can predict the risk of developing a disease well in advance of clinical diagnosis could offer the chance to pre-stratify future trials focused on preventive therapies.