Should we blame all the higher costs of clinical trials on the regulatory bodies, like FDA? No, suggests a new study from Tuft's Center for the Study of Drug Discovery. The study claims that one 1 in 5 procedures performed in late stage drug development is done to pursue "supplementary secondary, tertiary, and exploratory endpoints." This adds on average $1.1 M per trial. Across the industry that accounts for $4B to $6B per year for non-core endpoints -- enough to fund 2 x 2 Presidential campaigns!
Tuft's says that biopharm and pharm companies should take heed of this study result and can act on it to reduce development costs. Maybe that would save a few jobs in this industry. It certainly would likely make shareholders happier. See Fierce Biotech.
Posted by Bruce Lehr Nov 7th 2012.