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CMR analysis finds low phase II success rates

Friday, May 13, 2011 11:30 AM

Within the clinical trial industry, phase II success rates are lower than other stages of drug development and are getting worse, reports an analysis by the U.K.’s Center for Medicines Research (CMR), according to Pharma Times.

“As the current likelihood of a drug successfully progressing through phase III to launch is 50%, the overall attrition of late-stage drug development seems to be unsustainably high,” says John Arrowsmith, scientific director at Thomson Reuters in an article for Nature Reviews Drug Discovery.  Reuters acquired the CMR in 2006.

The CMR reviewed drug development projects at 16 companies which represented around 60% of global R&D spending.

The analysis revealed that phase II success rates for new development projects had fallen from 28% in 2006–2007 to 18% in 2008–2009.  However, rates varied between therapeutic categories as well as small molecules and biologics.

Reasons for failure were reported for many of the projects and often cited insufficient efficacy reasons, strategic reasons and preclinical safety reasons.

As for therapeutic categories, the data for 2008 to 2010 show that 68% occured in four therapeutic areas: alimentary/metabolism (23 failures), cancer (21), neuroscience (17) and cardiovascular (12). Notably, 61% (14 out of 23) of the failures in the alimentary/metabolism category were for diabetes.

“Although it is difficult to draw conclusions from these data, the finding that a substantial proportion of Phase II failures were due to strategic reasons suggests that one important underlying factor could be overlapping R&D activity between companies with drugs in phase II trials,” Arrowsmith suggests.

“This raises the question of whether an increase in collaborative efforts between companies up to the point of proof-of-concept for novel targets or mechanisms might be more cost-and time-effective.”

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