BOSTON, MA--(Marketwire - October 30, 2008) - Improved protocol design, perhaps more than any
other drug development stratagem, holds the key to faster and more
efficient development, according to the Tufts Center for the Study of Drug
Development.
"Drug sponsors have been working hard to reduce development cycle times and
costs by aggressively managing project timelines and investigative site
performance, and by conducting trials in emerging global regions, but these
strategies have a marginal impact on improving overall drug development
efficiency," said Tufts CSDD Director Kenneth I Kaitin.
Speaking at a meeting of drug industry leaders to identify best practices
in the development of protocols, recently convened by Tufts CSDD, Kaitin
said, "Major advances in development efficiency comes from better clinical
trial design."
Improved protocols, which provide step-by-step guidance for the conduct of
clinical trials, have been shown to have a pronounced effect on reducing
performance burdens and costs and accelerating development cycle time,
according to Tufts CSDD research.
Average clinical development times for new drugs in the U.S. since 1993,
when new regulations to speed drug development took effect, have hovered
around 6.6 years. During the same period, time required for regulatory
approval has trended downward from an average of 2 years in 1993-95 to 1.1
years in 2005-07, according to Tufts CSDD.
Participants at the meeting, part of Tufts CSDD's Executive Forum
Roundtable Series, noted that good protocols:
-- Include input early on from project managers, investigators, and study
coordinators.
-- Match protocol details with data collection tools.
-- Provide enough information to justify core aspects of the protocol,
e.g., design, dose, comparator, target criteria, patient population.
-- Are simple in design, adhere to industry standards, and can be
understood worldwide.
SCHEDULED R&D MANAGEMENT ROUNDTABLES
Upcoming Tufts CSDD Roundtable meetings will focus on the following:
-- Nov. 6, 2008 - Assessing Change and Opportunity in the Phase I
Landscape
-- Feb. 26, 2009 - In-Licensing/Out-Licensing Strategies and Practice
To register, call 617-636-2170.
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. A core element of the
center's educational efforts, the Tufts CSDD Institute for Professional
Development, produces the Executive Forum Roundtable Series, along with
postgraduate level courses, training workshops, symposia, and public
forums.
Contact Information: Contact:
Tufts Center for the Study of Drug Development
Charlene Neu
617-636-2187
Business Communication Strategies
Peter Lowy
617-734-9980