BOSTON, MA -- (MARKET WIRE) -- May 15, 2007 -- While drug developers over the past six years
have stepped up the number of postmarketing studies they conduct on newly
approved medicines, sponsors feel that those studies have contributed
little to their understanding of safety, efficacy, or quality, a recently
completed assessment by the
Tufts Center
for the Study of Drug Development shows.
According to a Tufts CSDD survey, 68% of clinical study sponsors and 79% of
non-clinical study sponsors said results contributed either marginally or
not at all to their understanding of the safety, efficacy, or quality of
their product.
However, 32% said clinical studies significantly or very significantly
increased their understanding of their products.
"A lot of progress has been made in the area of postapproval studies since
2001, when the U.S. Food and Drug Administration regulation requiring
sponsors to provide annual reports on the status of postmarketing studies
went into effect," said Tufts CSDD Associate Director Christopher-Paul
Milne. "But a major challenge drug sponsors face is completing the studies
on time."
More than half of all postmarketing studies, for which final study reports
were submitted, were finished by their projected completion date, Tufts
CSDD found, but 45% were delayed due to enrollment problems, technical
difficulties, additional FDA requirements, or sponsors expanding the scope
of their own studies.
The Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to
request postmarketing study reports, is due for renewal in Congress later
this year.
The analysis, reported in the May/June Tufts CSDD Impact Report, released
today, also found that:
-- Clinical studies, on average, took 10 months longer to complete and
cost nearly nine times as much as non-clinical studies.
-- Postmarketing studies are typically the responsibility of applicable
R&D departments, e.g., clinical development, preclinical, toxicology,
laboratory, not marketing departments, as some PDUFA critics claim.
-- Between 1998 and 2005 sponsors spent, on average, $5.3 million per
clinical postmarketing study, compared to $610,000 per non-clinical study.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (
http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues
and hosts symposia, workshops, and public forums, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.
Contact Information: Contact:
Tufts Center for the Study of Drug Development
Peg Hewitt
617-636-2185
Email Contact
Business Communication Strategies
Peter Lowy
781-326-9980
Email Contact