Contact Information: Contact: Tufts Center for the Study of Drug Development Charlene Neu 617-636-2187 Business Communication Strategies Peter Lowy 617-734-9980
Drug Developers Looking to Learn as Much as Possible in Phase I Trials, According to Tufts Center for the Study of Drug Development
BOSTON, MA--(Marketwire - January 27, 2009) - Under pressure to develop new medicines more
quickly and at lower cost, drug sponsors are looking to answer as many
questions as possible in Phase I, including those relating to efficacy as
well as safety, according to the Tufts Center for the Study of Drug
Development.
"The desire to learn more from Phase I studies has led to greater protocol
complexity and larger trials, which, with growing regulatory oversight, has
helped drive up costs and lengthen timelines, which is just the opposite of
what the industry needs to achieve," said Tufts CSDD Director Kenneth I
Kaitin.
In addition, developers are increasing their reliance on patient volunteers
-- now accounting for 38% of all human subjects in Phase I studies -- who
typically cost more to recruit and retain than healthy volunteers.
To help temper, if not reverse, the ever-growing cost of Phase I trials,
the research-based drug industry as a whole will likely increase its use of
outsourced services and make greater use of biomarkers and diagnostic
tests, according Kaitin.
Kaitin made his remarks at a meeting of drug industry leaders recently
convened by Tufts CSDD to discuss challenges and opportunities in the Phase
I landscape.
Participants at the meeting, part of Tufts CSDD's Executive Forum
Roundtable Series, noted that:
* Integrated studies -- those with multiple objectives -- are likely to
grow in popularity, partially in response to financial constraints,
especially in smaller organizations.
* Pressure on drug developers to maximize the amount of information they
obtain in Phase I studies will increase pressure on CROs to achieve proof
of concept as soon as possible.
* Public concern over clinical trial safety is likely to keep pressure on
sponsors to disclose information about ongoing studies.
SCHEDULED TUFTS CSDD EXECUTIVE FORUM ROUNDTABLES
Tufts CSDD Executive Forum Roundtable meetings in 2009 will focus on the
following:
* Feb. 26 - In-Licensing/Out-Licensing Strategies and Practice
* May 14 - Outsourcing: Economic and Operational Assessments
* Sept. 10 - Best R&D Practices of Top Pharma/Biotech Performers
* Nov. 12 - Comparative Approaches to Capacity Forecasting
To learn more, 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.