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Tuesday, August 9, 2011

Deteriorating Quality in Global Trials

Jean-Pierre Tassignon, MD, PhD
A recent study (2010 Pharmaceutical R&D Factbook) indicates that the decade-long drop in the overall success rate of pharmaceutical R&D continued in 2009. The authors found that "the number of experimental drug projects terminated at the final Phase III stage of development had doubled in 2007-2009 compared with 2004-2006."
We can postulate that suitable dose-effect relationships were demonstrated in Phase II clinical trials for these failed drug projects. Rather than infer that preclinical research through Phase II has suddenly become error-prone, there is merit in assessing the validity of Phase III clinical trials today.
Until the late 80s, Phase III trials were conducted essentially in North America and/or Europe. The drug pipeline delivered twice as many innovative medicinal products annually. Clinical research globalized over the last two decades by following the path of diminishing GDP per capita. The evidence comes from plotting the year of the first FDA inspection in any particular country versus GDP per capita in that country.
Our research evaluated the clinical trial participation of sites in North America and in Europe in Phase II and III industry trials in the period 2004-2006 compared with 2007-2009. North America participated in 60% of Phase II trials worldwide in both periods, twice more than Europe. The complexity of trial protocols is growing fast in Phase II, driving up the costs of procedures and labs. According to a Tufts Center for the Study of Drug Development news item from May 5, 2010 the high medical technology content of Phase II studies may explain the dominance of North American sites in Phase II trials.
Jean-Pierre Tassignon, MD
Applied Clinical Trials, Jan 1, 2011


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