Clinical Trials Offices Changing Academic Health Center Research Infrastructure

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Thu Aug 27, 2009 2:39pm EDT

Strategic Examination and Consolidation of Services Recommended by the AAHC

WASHINGTON, Aug. 27 /PRNewswire-USNewswire/ -- Little uniformity exists in the
structure or functions of clinical trials offices, and models are needed for
the future, according to Clinical Trials Offices:  What's New in Research
Administration?, a new report from the Association of Academic Health Centers
(AAHC).  Emerging centralized clinical trial offices (CTOs) are among the
newest developments within the research administration infrastructure of
academic health centers -- where leaders are focused on optimizing resources
and developing strategies to sustain and transform the nation's research
enterprise.  The report notes that a trend towards consolidation or
centralization in the administration of clinical trial functions has been
ongoing for several years -- but is far from accomplished.

Report authors, Elaine Rubin, AAHC vice president for policy and program, and
Danielle Lazar, AAHC program associate, profiled eight academic health
centers, addressing the development, organization, structure, and activities
of the clinical trials office (CTO).  Operating budgets of profiled CTOs
ranged from $400 thousand to over $4 million with compliance responsibilities
that ranged from contracting and cost analysis to education and training.

The report not only provides important insights on the strategies and
initiatives to create systems for the future but also institutional cultural
change and the challenges that academic health center leaders face to ensure
the research enterprise evolves to address new scientific developments,
translational research, and interdisciplinary, multisite research.

Study findings reveal that many institutions are still stressed and challenged
by the lack of a clearly defined organization and governance structure for
clinical trials administration.  "Academic health center leaders should
examine the organization and structure for clinical trials administration
within their respective institutions and determine what, if any, changes are
needed to consolidate and optimize the research infrastructure," said Dr.
Rubin, who also pointed out that important tools, such as the AAHC's Clinical
Trials Administration Toolkit, exist to help with this process.

The AAHC is a national non-profit association dedicated to advancing the
nation's health and well-being through the vigorous leadership of academic
health centers.


SOURCE  Association of Academic Health Centers

Lynn Bentley of the Association of Academic Health Centers, +1-202-265-9600
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