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Report from the National Cancer Advisory Board Meeting
The National Cancer Advisory Board (NCAB) recently convened
its quarterly meeting in Bethesda,
Maryland on September 20-21, 2005.
The NCAB functions as an advisory board to the Secretary of the Department of
Health and Human Services (DHHS) and the Director of the National Cancer
Institute (NCI). Members of the NCAB are appointed by the President of the United
States,
and the board is comprised of researchers, academicians, physicians, and
advocates with expertise in cancer research. Of specific interest at the recent
NCAB meeting were the reports from three working groups which are focused on:
translational research; increasing the efficiency of NCI’s biorepositories; and
ensuring the recruitment of under-represented populations in clinical trials.
Dr. Ernest Hawk, Director of the Office of Centers, Training
and Resources for NCI, presented the report from the Translational Research
working group, which supports the role of translational research in evolving
medicine from treating cancer at the time of diagnosis to predicting and
preventing cancer before it begins. As part of this, the Translational Research
working group tracks the support grants going to cancer centers, and works to
promote collaboration and coordination between those centers and the community.
This working group also monitors the SPORE (Special Programs of Research
Excellence) program, which focuses on developmental research and transforming
novel ideas into clinical interventions. Dr. Hawk’s report emphasized the role
of the working group in evaluating the current status of NCI’s investment in
translational research – such as cancer center grants and SPORE funding – while
also providing vision to ensure that these programs are aligned with NCI’s 2015
goal of eradicating death and suffering due to cancer. Currently, his working
group is embarking on the research and strategic planning necessary to create
the recommendations that will ultimately provide this vision for NCI’s
translational research efforts.
A report on NCI’s efforts to streamline its biorepositories
was presented by Dr. Anna Barker, Deputy Director of Advanced Technologies and
Strategic Partnerships at NCI. This working group is charged with developing
policies and procedures for NCI’s biorepositories to use, in an effort to
promote the utilization of patients’ tissue samples to help advance crucial
research. Dr. Barker’s report centered on two meetings that the working group
held this past summer, to gather researcher and advocate input on key issues
surrounding biorepositories. The first meeting focused on the policies and
procedures needed to ensure that biorepositories work efficiently, and the
second meeting discussed the ethical and legal implications of storing and using
patients’ tissue samples. The Research Advocacy Network – along with other
advocates – attended both these meetings to provide input from the community’s
perspective. This input was then used by Dr. Barker and the working group as
the basis for their recommendations, which included implementing consistent
“best practices” for each biorepository to use; developing quality assurance
standards including stringent staff training and standard operating procedures
for labs; creating a standard consent document for patients; and developing
guidelines for disclosing research results to patients.
Another report of interest was given by Dr. Robert Croyle,
Director of the Division of Cancer Control and Population Sciences at NCI,
sharing the compiled findings from 45 different studies examining barriers and
opportunities to trial enrollment in varying populations and age groups. The
working group confirmed that some of the most common barriers to trial
participation include a mistrust of research and the medical system, lack of
education about clinical trials, logistical constraints, and perceived harms.
Based
on its analysis of these studies, the working group developed recommendations
such as: requiring each clinical trial to report its recruitment goals and
results; training investigators to be sensitive to the varying needs of patient
populations; evaluating the role of under-represented healthcare professionals
in clinical trial recruitment; and studying targeted recruitment interventions
to identify effective methods for outreach.
These working group reports – as well as the other
presentations at the NCAB meeting – give us a glimpse of the direction that
cancer research and collaboration is heading. Because this meeting touched on
several areas of interest and concern to advocates, the community should stay
attuned to NCAB’s progress to help ensure that patients’ interests remain
central to its efforts.
Controversy and Questions Surround the CIRB and Its Utility
Follow-up The Coalition of Cancer
Cooperative Groups convened a meeting of its Patient Advisory Board (PAB) on
September 27th to discuss issues central to encouraging progress in cancer
research and increasing patient participation in clinical trials.
A key agenda item discussed at this meeting was the controversial
role of the Central Institutional Review Board (CIRB) in approving protocols
and amendments to Phase III clinical studies. The concept of the CIRB emerged
as a solution to provide independent review of approved protocols, in an effort
to help expedite the review process at local Institutional Review Boards (IRBs).
Launched in 1998, the intent behind the development of the CIRB – which is a
National Cancer Institute (NCI)-sponsored organization – was to streamline the
approval process for all Phase III multi-center trials conducted by the
cooperative groups, by eliminating the work of protocol review at the local IRB
level.
When the CIRB was implemented seven years ago, it was done
so as a pilot initiative with just a handful of local IRBs participating, and
with plans to evaluate its effectiveness prior to expanding the program. However,
shortly after the program was introduced, the Cancer Therapy Evaluation Program
(CTEP) – an arm of NCI – decided that the CIRB’s decisions should apply to all
local
IRBs, regardless of whether or not they were part of the pilot program. Local
IRBs that prefer to review protocols according to their own procedures – rather
than accepting the CIRB’s process – cannot begin enrolling a study before the
CIRB has approved it. Some advocates believe that this type of bureaucracy can
delay a study from opening for up to two months, ultimately hurting cancer
patients who may be dying while they wait for a clinical trial to begin
enrollment.
And this effort to make local IRBs conform to the CIRB
doesn’t make sense when you look at the numbers. Advocates close to the program
estimate that currently only 10-20% of local IRBs have opted for representation
by the CIRB, so it is concerning to them that CTEP wants the CIRB to retain
influence over all IRBs.
To help remedy the situation, the PAB conducted in-depth
interviews with 39 stakeholders and compiled a thorough report of
recommendations for the Director of NCI in August of 2002. Unfortunately,
advocates involved with the development of that report believe that NCI has yet
to respond to or implement those recommendations. Members of the PAB have also
offered to help the CIRB with problems related to ensuring consistency among
informed consent forms, but have had no support or response from the CIRB’s
leadership on that.
With so much controversy and concern swirling around the
CIRB, observers have asked NCI to evaluate the body so the community can
quantify whether it has been effective in streamlining protocol review or whether
it has just added another layer of complication to the process. After several
years of requests from the advocate community, NCI has agreed to an evaluation
which is just now being implemented. But because the CIRB is contracting out
the audit, there is some hesitation that it may not be truly objective because
it is not an independent review.
In spite of this ongoing debate, the PAB did have possible
solutions for some of the issues that the CIRB faces. Perhaps most crucial,
some advocates on the Patient Advisory Board recommend that the CIRB remove the
constraint that local IRBs – which are not affiliated with the CIRB – must
still wait for the body’s approval on trial protocols and amendments. Advocates
believe that this change would positively impact patients by reducing the
delays caused by the CIRB.
Some advocates wonder how the CIRB has continued to exist
without any formal evaluation being completed, and without any pre-determined
metrics on what constitutes success. These are accountability issues that come
up with any new program or initiative. So we as advocates must learn from the
CIRB’s challenges in order to ask tough questions of other pilot programs that
we are involved with, helping to ensure that science and patients do no suffer
as a result of disorganization.
New Leadership at the FDA is Announced
The following is a follow up to an article in last month’s
Network News available at:
On Friday, September 30th Andrew von Eschenbach, the
director of the National Cancer Institute and newly appointed acting
commissioner of the FDA, announced he will give up his daily duties at the NCI
to focus on his new position at the FDA. John Niederhuber, former director of
the University of Wisconsin Comprehensive Cancer Center, will manage day-to-day
operations at the NCI.
The announcement was in response to criticism from Congress
and some watchdog groups that Von Eschenbach could not perform both jobs well
and that he would face conflicts of interest. Von Eschenbach stated that while
at the FDA he would “not participate in FDA reviews of drugs researched by the
NCI, FDA oversight of potential side effects seen in NCI-sponsored studies or
other matters involving NCI as a party in which FDA is exercising its
regulatory authority.” Critics are calling for both agencies to have permanent,
competent, full-time leaders.
Colon Cancer Alliance’s Colorectal Cancer Conference
The Colon Cancer Alliance (CCA) held their 5th Annual
Conference, Finding Hope, in Newark,
NJ, September 30 to October 2.
This year’s successful conference was attended by about 200 colorectal cancer
(CRC) patients, survivors, caregivers, and family members. The program covered
advances in the treatment of CRC, including radiation, surgery, oncology and
integrative medicine.
A unique feature of the conference was separate survivor’s
and caregiver’s forums, followed by the forum ”Roots of Support: Bridging Support for Survivors and
Caregivers”. Each of these panel sessions provided an opportunity for attendees
to ask questions of healthcare professionals and their peers, which generated
discussion among the audience. The sessions were marked by the openness of
participants to share their experiences.
There were also breakout sessions that addressed Hope and
Quality of Life, Managing Metastatic Disease, Pain Management and Palliative
Care, and Making Your Voice Count in Your Community. Making Your Voice Count
was co-lead by Angela Brown, manager of CCA’s Voices project, and Judy Perotti,
co-founder of RAN. Judy presented an overview of patient advocacy and clinical
trials, while Angela presented an over view of the CCA’s Voices project. Voices
campaign will introduce colorectal cancer (CRC) to local communities, as well
as uniting CCA volunteers across the country. Each Voice’s Chapter is
encouraged to participate in advocacy and event functions. A list of current
Voice’s Local Chapters can be found at https://www.ccalliance.org/what/voiceschapters/chapter.html
For more information about CRC advocate groups visit:
Correction:
The reference to AACR was incorrect in the last issue of
Network News. It should be the American Association for Cancer Research. More
information about AACR can be found at: www.aacr.org.
Our apologies to AACR for any confusion.
New Fact Sheets Available
Two new fact sheets have been added to the
"What it Means for Me" Fact Sheet Series. The new topics are on the
results of the Avastin and Herceptin studies in breast cancer. These are
available for download on the Research Advocacy Network Publications area
of the website.
Research Advocacy Network Website
www.researchadvocacy.org
Check out the first version of our new website at www.researchadvocy.org. New areas have been added and more will come soon. Be
sure to join Research Advocacy Network with the "Join" link. There
is no charge for Network membership and this will assure that you receive all
notices and have access to Network programs.
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Research Advocacy Network Activities:
Oct 1...........Presentation
at Colon Cancer Alliance Conference
Oct 5...........Indiana Cancer
Consortium
Oct 5...........IRB
Community Member Training, Rush
University Medical
Center
Oct 6-9........Lynn
Sage Breast Cancer Conference
Oct 31.........NCCN/
RAN Advocate Lecture Series Webconference 1: Research Into Practice
Nov 7...........NCCN/
RAN Advocate Lecture Series Webconference 2: Research Into Practice
Nov 14.........NCCN/
RAN Advocate Lecture Series Webconference 3: Research Into Practice
*For more
information about this Lecture
Series, please email info@researchadvocacy.org
Nov 18-21...ECOG
(Eastern Cooperative Oncology Group)
Dec 3...........PRIM&R
/ ARENA Pre-Conference Workshop for IRB Community Members
Dec 3-6.......PRIM&R
/ ARENA Annual Conference
Dec 8-11.....San
Antonio Breast Cancer Symposium
Do you know of conferences/meetings/ activities that you would
like posted to the calendar? Let us know at info@researchadvocacy.org.
Your Two Cents Make
a Difference!
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need your help! If you believe in the hope of research and the power of
advocacy, you can help the Research Advocacy Network by sending a donation. RAN
is an exempt 501 c 3 organization and dependent on your support to keep going.
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THANKS!!!
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Editors and Authors:
Elda Railey, Judy Perotti, Mary Lou Smith
Special thanks to contributing author to this issue: Cheya
Pope
Research Advocacy
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