Published Online: Thursday, June 1, 2006

New clinical trials rose by >50% since 2002, signaling a possible comeback in research and development (R&D) productivity. The Tufts Center for the Study of Drug Development (CSDD) analysis found that in 2003-2005 the rate at which the 10 top-selling US drug companies started clinical trials for new drugs increased by 52%, following a 21% fall from 1993-1997 to 1998-2002.

It is too early to predict whether big pharma's R&D productivity can sustain the momentum. The average clinical phase time for new drugs receiving FDA approval in the United States is 7 years. "The real proof will be in the ability of companies to avoid late-stage development terminations and boost overall clinical success rates," said Tufts CSDD Director Kenneth I Kaitin, PhD. "Prior to the 2003-2005 period, clinical approval success rates increased modestly. It remains to be seen whether further improvement in success rates will apply to the recent crop of products entering clinical testing," he added.

Concurrent with the rise in new clinical trials, the biggest drug companies expanded their reliance on licensed-in compounds. The share of licensed compounds in the development portfolios of leading firms increased from approximately 1 in 7 in 1993-1997 to 1 in 4 in 2003-2005, according to the study results reported in Tufts CSDD Impact Report (May/June 2006).

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