According to the report Outlook 2009 released by the Tufts Center for the Study of Drug Development, gains made by the U.S. FDA in the speed of review of new drugs (average review time declined by 1.1 years in time 2005-2007 period) have been largely offset by longer clinical development times due to the complexity of the diseases being studied. Approval times continue to average around 8 years. According to Tufts director Kenneth I Kaitin, drug companies are employing various strategies to speed up clinical development. These include streamlining project management, strategic partnerships and licensing arrangements, use of surrogate endpoints and adaptive clinical trials.
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