Current Challenges of Clinical Research on Humans:

One-half of the compounds that enter Phase III ultimately fail according to the FDA. In addition, the number of approved new drugs is decreasing as the cost of clinical trials increases 12% annually. Clearly there is a distinct gap between information gathered at checkpoints and the decision for committing financial resources to the compounds that are most likely to succeed.

Human testing requires an extensive protocol to confirm safety and efficacy of a new drug. Critical parameters in these protocols, such as serum markers, inclusion/exclusion criteria, dosing, and timing of drug administration, will directly affect the success or failure of the test. Unfortunately, pre-clinical testing information provides only limited information for these characteristics. Therefore, clinical experts are then left to hypothesize the rest.

© 2009 Immunetrics