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After a successful pilot year of PACE
Initiative activity, Stage Two launches the newest venture to
include both corporate and non-corporate sponsors as full PACE
Initiative members with the aim of providing each the
opportunity to help shape the comparative effectiveness research
policy agenda as it unfolds within both the private and public
sectors in the US and, at a later time, possibly
internationally. This critical stage will provide sponsors a
focused forum to discuss, debate, guide, and possibly resolve or
adopt important science, policy, and business issues relative to
comparative effectiveness trial research.
Stage One
In January, 2008, UBC launched Stage One of
an ambitious effort termed the PACE (Pragmatic Approaches
to Comparative Effectiveness) Initiative. The
initial stage was intended to contribute to the national
dialogue about comparative effectiveness research.
Specifically, the PACE Initiative endeavors to stimulate novel,
pragmatic solutions for clinical study designs in comparative
effectiveness trial applications. These novel concepts include
trial simulation; adaptive techniques including integrated,
sequential, and Bayesian statistical methods; pragmatic clinical
trial designs; and, large simple trials. It is the contention of
the PACE Initiative that without true transformational
re-thinking in the design and operation of comparative
effectiveness trial methods, the private and public sectors risk
wasting vast amounts of money answering the wrong questions, or
the right questions too late, thereby lessening the opportunity
to achieve the ambitious objectives of improving the quality and
cost efficiency of health care.
First year accomplishments included convening
an Advisory Board, securing corporate sponsorship, developing
and launching a website, hosting seminars and forums, recruiting
scientific staff, initiating a working paper series, nurturing
collaborative relationships, and providing advisement to federal
policymakers.
For a transformation to occur, however, a
number of policy, analytical, and operational issues need to be
identified, tested, resolved, communicated, and, as appropriate,
adopted. The PACE Initiative is committed to facilitating such
a transformation by functioning as a catalyst for responsible
change in related policies and engaging in research activities
to foster responsible methods such that CER trials are useful,
feasible, efficient, and pragmatic.
Stage Two
In Stage Two, PACE Initiative members will
play a vital role in guiding the Initiative’s agenda and
resulting activities. We anticipate that the features and
offerings of membership will grow and/or change over time as
membership grows and the needs and interests of the PACE
Initiative Sponsor’s Advisory Council (PSAC) develop and are
expressed. Membership offerings will include:
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participation in the PACE Initiative
Sponsor Advisory Council (PSAC);
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opportunities to sponsor and/or
contribute to (including possible co-authorship) the PACE
Initiative Working Paper Series;
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regular updates on CER trial-related
issues;
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outreach opportunities.
Each of these offerings will provide PACE
Initiative members with an active, hands-on substantive role in
crafting realistic and innovative approaches and solutions to
some of the most pressing national research questions.
Finally, an additional, albeit more
intangible, benefit of being a PACE Initiative member is access
to PACE staff who will be increasingly knowledgeable about CER
trial state-of-the-art, state-of-information, state of activity,
and who will maintain working relationships with other related
organizations and key opinion leaders associated with this
dynamic, clinical, business and policy relevant field.
For more information, or to discuss specific
membership interests, please contact Dr. Bryan Luce, Director of
the PACE Initiative, at
bryan.luce@unitedbiosource.com. |
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