Pharmaceutical Statistics Using SAS

1.4. Battling a high Phase III failure rate

The attrition rate of compounds in the pharmaceutical industry is extremely high. Setting aside compounds that fail the preclinical testing, it is generally recognized that less than 12% of compounds entering into the human phase testing will eventually make to the market place. The rate is a composite figure formed as the product of the success rates of passing the Phase I testing, passing the Phase II testing, passing the Phase III testing, and passing the regulatory review. Among failures at the various stages, Phase III attrition has the greatest impact. This is so not only because of all the accumulated resources expended up to this point, it is also because Phase III failure represents a great ...