National call for cancer trial system to be more responsive to community needs
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Addressing the nation’s continuing poor performance in cancer clinical trial participation, particularly among racial and ethnic minorities and low income groups, will require meaningful public involvement in the design and implementation of clinical trials, according to a landmark report released today.
Despite many previous calls for community participation and engagement, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy is the first report to define how the cancer clinical trial system can involve communities affected by cancer: from trial design - to implementation - to dissemination of research results. Among the report’s 58 recommendations are calls for:
- National research sponsors - both public and private - and local researchers to more meaningfully integrate community representatives and patient advocates into the cancer research development process
- Institutional Review Boards (IRBs) to be comprised of 25% community members; and for IRB members to consider evidence of community engagement in the cancer clinical research studies they review
- Local researchers to develop mechanisms, such as community advisory boards (CABs), for ongoing community input into local cancer research implementation
- National research sponsors to develop national recruitment and retention plans to assist local researchers in identifying appropriate research participants, particularly within minority and non-English speaking populations
- National research sponsors to form partnerships with patient advocacy and community organizations, to ensure that clinical trials results are disseminated in ways that patients and the broader public can understand and act upon.
The Communities as Partners in Cancer Clinical Trials project, convened by the Education Network for Advancing Cancer Clinical Trials (ENACCT) and Community-Campus Partnerships for Health (CCPH), is funded by a core grant from the Agency for Health Care Research and Quality (AHRQ) and the National Cancer Institute. “AHRQ is proud to be a core sponsor of this initiative,” said AHRQ Director, Carolyn Clancy. “We’re delighted to see that two of our evidence reports provide a foundation for this ‘call to action’ to improve cancer clinical trial participation, especially among underserved populations.”
The Lance Armstrong Foundation (LAF), another project sponsor, sees promise in the report’s recommendations. “Communities as Partners builds on what we know works in other types of research - namely, engagement of patients, survivors and at-risk communities in the research process. It’s what we need to do to improve clinical trial accrual and ultimately, to prevent suffering and death due to cancer,” said LAF Vice President of Programs and Policy, Andy Miller.
Over a two year period, ENACCT and CCPH engaged a diverse group of stakeholders - including Federal agencies, patient advocacy and community-based organizations, cancer centers, oncology practices, health professional schools, philanthropy, the pharmaceutical industry and health care professional societies - many of whom had never before met together– to develop the recommendations for improving patient participation rates and addressing persistent disparities in phase III cancer clinical trials.
Nancy Roach, cancer survivor and Chair, Board of Directors of C3: Colorectal Cancer Coalition, who participated in the process, sees greater community engagement in cancer clinical trials as a positive step. “Greater representation of all people affected by cancer in the clinical trial development and implementation process should lead to better outcomes and faster cures for all cancer patients.”
Coinciding with the release of the report, ENACCT and CCPH are also announcing a call for “Implementation Partners,” which will provide seed grant funding and technical assistance to help support implementation of the report’s recommendations. Proposals are due on December 5, 2008.
The full report, report summary, and call for implementation partners are available on the project website at http://www.communitiesaspartners.org
The Education Network to Advance Cancer Clinical Trials’ (ENACCT) is the only national organization devoted solely to implementing and evaluating clinical trial educational efforts. ENACCT’s mission is to identify, implement and validate innovative community centered approaches to cancer clinical trials education. In its work, ENACCT: Develops and delivers the highest quality, evidence based, community-focused clinical trials education programs for health care providers, patients, and the public; offers high quality, fee-based services that enhance the capacity of organizations conducting cancer clinical trials outreach, education and recruitment; and advocates for the inclusion of appropriate cancer clinical trials education as a top national priority. For more information, visit www.enacct.org
Community-Campus Partnerships for Health (CCPH) is a nonprofit organization that promotes health (broadly defined) through partnerships between communities and higher educational institutions. Founded in 1996, CCPH is a growing network of over 1,800 communities and campuses across North America and increasingly the world that are collaborating to promote health through service-learning, community-based participatory research, broad-based coalitions and other partnership strategies. These partnerships are powerful tools for improving higher education, civic engagement and the overall health of communities. CCPH advances its mission by disseminating information, providing training and technical assistance, conducting research and evaluations, developing and influencing policies, and building coalitions. The organization is based at the Medical College of Wisconsin in Milwaukee, WI. For more information, visit www.ccph.info
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