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National call for cancer clinical trial system to be more responsive to community needs
November 11, 2008Addressing 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.
Medical College of Wisconsin
* 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.
Medical College of Wisconsin
Clinical Trials Current Events and Clinical Trials News RSSEffect of real-time CPR feedback reported at resuscitation science symposium
Emergency medical service (EMS) providers in the United States assess an estimated 350,000 cardiac arrests each year. Only 5 to 10 percent of people who have sudden cardiac arrest survive. Better quality cardiopulmonary resuscitation (CPR) provided by prehospital EMS providers may be associated with better patient outcome.
Milestone biodefense publication by Elsevier journal Vaccine
Last week during the 'Vaccines for Biothreats and Emerging and Neglected Diseases Symposium' in Galveston TX, USA, the Elsevier journal Vaccine released a supplement dedicated to vaccines for biodefense.
On the Trail of a Vaccine for Lyme Disease: Yale Researchers Target Tick Saliva
A protein found in the saliva of ticks helps protect mice from developing Lyme disease, Yale researchers have discovered. The findings, published in the November 19 issue of Cell Host & Microbe, may spur development of a new vaccine against infection from Lyme disease, which is spread through tick bites.
Cognitive dysfunction reversed in mouse model of Down syndrome
A study by neuroscientist William C. Mobley, MD, PhD, chair of the Department of Neurosciences at the University of California, San Diego School of Medicine, and colleagues at Stanford University Medical School has demonstrated a possible new approach to slowing the inevitable progression of cognitive decline found in Down's syndrome.
A Second Skin
Despite advances in treatment regimens and the best efforts of nurses and doctors, about 70% of all people with severe burns die from related infections.
Heart and bone damage from low vitamin D tied to declines in sex hormones
Researchers at Johns Hopkins are reporting what is believed to be the first conclusive evidence in men that the long-term ill effects of vitamin D deficiency are amplified by lower levels of the key sex hormone estrogen, but not testosterone.
Researchers find potential treatment for Huntington's disease
Investigators at Burnham Institute for Medical Research (Burnham), the University of British Columbia's Centre for Molecular Medicine and Therapeutics and the University of California, San Diego have found that normal synaptic activity in nerve cells (the electrical activity in the brain that allows nerve cells to communicate with one another) protects the brain from the misfolded proteins associated with Huntington's disease.
Viagra for women? Drug developed as antidepressant effective in treating low libido
Pooled results from three separate clinical trials of flibanserin, a drug originally created as an antidepressant, show it is effective in treating women with acquired hypoactive sexual desire disorder. These trials were the first ever to test a therapy that works at the level of the brain to enhance libido in women reporting low sexual desire.
Mechanical ventilation for patients with lung damage don't always work as planned
As more Canadians are diagnosed with H1N1 influenza infection, some will be admitted to hospital. The most severely affected may be treated in the intensive care unit (ICU) and placed on a mechanical ventilator to help them breathe while they recover from the infection.
UT Southwestern aids national effort to recruit volunteers for medical research
A new national initiative involving UT Southwestern Medical Center will match volunteers who want to take part in medical research studies with the scientists who are leading those studies.
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