Pharmacy Times, Volume 0, 0

New clinical trials rose by >50% since2002, signaling a possible comeback inresearch and development (R&D) productivity.The Tufts Center for the Study ofDrug Development (CSDD) analysis foundthat in 2003-2005 the rate at which the 10top-selling US drug companies startedclinical trials for new drugs increased by52%, following a 21% fall from 1993-1997to 1998-2002.

It is too early to predict whether bigpharma's R&D productivity can sustain themomentum. The average clinical phasetime for new drugs receiving FDAapproval in the United States is 7 years."The real proof will be in the ability ofcompanies to avoid late-stage developmentterminations and boost overall clinicalsuccess rates," said Tufts CSDDDirector Kenneth I Kaitin, PhD. "Prior to the2003-2005 period, clinical approval successrates increased modestly. It remainsto be seen whether further improvementin success rates will apply to the recentcrop of products entering clinical testing," he added.

Concurrent with the rise in new clinicaltrials, the biggest drug companiesexpanded their reliance on licensed-incompounds. The share of licensed compoundsin the development portfolios ofleading firms increased from approximately1 in 7 in 1993-1997 to 1 in 4 in2003-2005, according to the studyresults reported in Tufts CSDD ImpactReport (May/June 2006).