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Communities as Partners workgroups
develop draft recommendations and convene second
invitational meeting
Following their first invitational meeting in
September 2007, participants in the Communities
as Partners project organized into
three workgroups, reflecting the design and implementation
of Phase III Clinical Trials, with a strong emphasis
on the National Cancer Institute Cooperative
Group Program:
- Trial
Design and Implementation Process at the
National Level;
- Implementation
Process at the Local Level; and
- Interpretation
and Dissemination at the National and Local
Levels
These workgroups were charged with developing
specific recommendations for community engagement
in phase III cancer treatment trials. The workgroups
met via conference call to examine 24 distinct
components of design, implementation and dissemination
in these trials and develop CBPR-inspired recommendations
for each component. A set of guiding principles
informed the workgroups’ efforts, including a
desire to build upon the efforts of researchers
and patient advocates in the cancer clinical
trial system who are already working to engage
communities as partners and an understanding
that while we are challenging the cancer clinical
trial system to change, we must also work within
the system. An initial set of 55 preliminary
draft recommendations were completed in February
2008 and circulated widely for comment.
Vetting and Refining Initial Draft Recommendations
The workgroups reconvened in College Park, MD
in March 2008 to review the many comments received
on the preliminary draft recommendations and
to advance those that are the most feasible and
impactful. Project staff and participants are
now in the process of revising the preliminary
draft recommendations based on the meeting deliberations.
Although still in draft form, these recommendations
are central to the strategic plan:
National Design and Implementation:
- Broaden
and enhance the community/patient representative
role in cooperative group research through
establishing an open, transparent process
for recruiting community/patient representatives;
formalizing responsibilities and expectations;
and training community representatives
- Require
the development of national outreach and
recruitment plans for all Phase III studies,
which can be customized locally
Local
Implementation:
- Require
evidence of community engagement by local
investigators
- Broaden
and enhance community representative roles
and membership on Institutional Review Boards
(IRBs)
- Compensate
community representatives (financial or otherwise)
Data Interpretation and Dissemination:
- Create
a pool of community representatives trained
to participate in peer review, consumer editorials,
and other dissemination activities
- Notify
study participants of trial outcomes
- Set
priorities for broad dissemination of study
results through the mainstream media
A revised set of draft recommendations will be available for review in mid July, before the strategic plan is released in final form in September 2008.
Disseminating and Implementing the Strategic
Plan
Project staff and participants will engage key
stakeholders, including the national cancer cooperative
group members and advocates, the NCI, the American
Society for Clinical Oncology, patient advocacy
groups, industry and others, in disseminating
the strategic plan and promoting its adoption.
The project’s impact will also be strengthened
by a partnership with the Intercultural Cancer
Council’s Eliminating Disparities in Clinical
Trials (EDICT) project and its related recommendations.
Project Contact
For more information, contact Project Coordinator
Stacy Collins at stacy.collins@enacct.org or
visit the Communities as Partners website at http://www.enacct.org/conference/conference.php
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