Despite the fact that FDA has quickened its review and approval of new medicines, clinical development is taking longer because of the complex nature of the diseases for which the new therapeutics are being created. The average time for FDA to approve new drugs declined to 1.1 years in the 20052007 period, but longer average clinical phase time means that combined clinical and approval time is approximately 8 years.
"Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress," says Kenneth I. Kaitin, Director of CSDD. "Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols."
Companies have attempted to speed up clinical development by improving project management, expanding the use of partnerships and licensing arrangements, and increasing the use of surrogate endpoints and adaptive clinical trials. Kaitin says: "Still, in drug development, the race and rewards go to the swiftest and most efficient drug sponsors; those that can deliver safe and effective new medicines in the shortest time."
The findings come from the Tufts Center's Outlook 2009 report on pharmaceuticals and biopharmaceuticals. Among other trends cited, the report expects that firms will continue globalization of their preclinical and clinical development activities to overcome local capacity constraints, increase speed-to-market and expand their presence in emerging markets.