Research Advocacy Network Soon to Launch Genomics Education Module
The Research Advocacy
Network will be introducing a new
education module for advocates interested in learning more about genetics and
genomics and the role of this emerging field in cancer research.
The module covers the
science behind genomics, including
scientific concepts and examples of how genomic technology is currently being
incorporated into clinical research. To
help bring this information to life, the module also includes basic definitions,
diagrams, and graphics - all in an effort to de-mystify the science and
technology. The module was supported by an educational grant from
Genomic Health.
To help ensure that the
module resonates with the community,
the Research Advocacy Network conducted a focus group with several advocates
last July. The Research Advocacy Network
then updated the materials, based on feedback and suggestions from the focus
group participants.
Ultimately, the goal of
this program is to enable advocates to
learn about genomics and to then share that information within their own
organizations and constituencies. To
support those efforts, the Research Advocacy Network is planning to develop an
educational slide set to complement the module which will also be available through
its web site, beginning in early 2007. Watch the newsletter and www.researchadvocacy.org
for more details on the roll-out of this genomics training module.
Advocates Have an Opportunity
to Comment on Critical Health Issues
As advocates, we work hard to ensure that the patient perspective is
incorporated in research and clinical trial designs, in educational materials,
and in general outreach activities. Another
important way that the advocate community can influence the direction of
critical health issues is to participate in public comment periods when a new
idea or significant issue is being debated.
Government agencies have created public comment periods to do just that:
allow concerned citizens to express their opinions on controversial issues or
"hot topics" as new policies or regulations are under deliberation.
Although public comment periods are not limited to healthcare issues,
there are currently two health-related issues open for public comment which
have the potential to deeply impact our community - including advocates, researchers,
healthcare providers, and patients and their families. By educating ourselves on the key issues that
are being discussed, we have the opportunity to develop an informed opinion and
contribute to these public comment periods before the deadline expires, thus helping
to shape outcomes that are likely to affect the patients we serve.
The first
issue centers on the National Institute of Health's (NIH) proposed policy
surrounding the sharing of data gathered through Genome-Wide Association
Studies (GWAS). NIH both conducts and
supports studies that it classifies as "genome-wide," which examine genetic
variation across the entire human genome in an effort to identify genetic
associations that correlate to observable traits - such as high blood pressure
- or to the absence or presence of a disease or condition.
The goal of
these studies is to better identify and understand common genetic factors that
influence health and disease, and to disseminate that information broadly
throughout the research community to help accelerate clinical studies and new
treatments. By creating a central
repository for this data, NIH hopes to widely share the phenotypic and
genotypic information, thus enabling physicians to better address health needs
based on patients' individual genetic information.
But as with
the creation of any database containing health information, concerns around
privacy and safe-guarding the sensitivity of patient information exist as
well. NIH and the public need to work
together to determine what advantages and drawbacks surround this proposal,
including the related issues of GWAS data submission, scientific publication,
and intellectual property.
Advocates who are interested in learning more about the NIH's proposal can visit
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-094.html.
Those who wish to comment can do so via the following NIH Web site: http://grants.nih.gov/grants/guide/rfi_files/NOT-OD-06-094_rfi_add.htm.
As an alternative, comments may be submitted by e-mail to GWAS@nih.gov or sent by mail to
the following address: NIH GWAS RFI Comments, National Institutes of Health,
Office of Extramural Research, 6705
Rockledge Drive, Room 350, Bethesda, MD 20892-7963. Public
comments must be submitted by October 31, 2006 and should include notice number
NOT-OD-06-094.
Another opportunity for advocate input pertains to a draft guidance
published on September 7, 2006 by the Food & Drug Administration (FDA), asserting
that the agency now has the right to oversee and regulate the development of
genetic and genomic tests, which the FDA has re-named In Vitro Diagnostics Multivariate Index Assays (IVDMIAs). Historically, IVDMIAs have been
regulated by
the Clinical Laboratory Improvement Amendments (CLIA),
a division under the Centers for Medicare and Medicaid Services (CMS). But concern over the quality and reliability
of many of these tests has piqued FDA's interest, and so the agency is now working
to develop policies and procedures to regulate the arena of genetic and genomic
assays, including the creation of new pre-market pathways and post-market
requirements for the makers of these tests.
While some
regulation of IVDMIAs is clearly in the best interest of patients - ensuring
that their safety is protected and that the tests have been clinically
validated for accuracy - FDA's current approach could threaten the promise that
genomic research holds by stifling the innovation of these tests and ultimately
limiting patient access to them. In the
draft guidance FDA alludes to the possibility of even removing some of the
genomic assays currently on the market - such as Oncotype DXTM - in spite of rigorous clinical data, while the
Agency
determines whether a given test has sufficient clinical validity.
Because it
is a precarious road to finding the correct balance between patient safety and
access to innovative diagnostics and tests, this is an important issue for the
advocate community to learn more about and share their opinions on. Advocates can read the draft guidance online
at www.fda.gov/cdrh/oivd/guidance/1610.html. Comments can be
submitted by mail to the
Division of Dockets Management (HFA-305), Food & Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.
Alternatively, electronic comments can be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentsmain.cfm?
EC_DOCUMENT_ID=1215&SUBTYP=NEXT&CID=&AGENCY=FDA
Public
comments must be submitted by December 6, 2006 and should include the docket
reference number 2006D-0347.
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Research Advocacy Network
Activities
- Sept 7-8 - EDICT Clinical Trials Roundtable (see next month's newsletter
for report)
- Sept 14-16 - Lynn Sage Breast Cancer Symposium
- Sept 25- 28 - North Central Cancer Treatment Group (NCCTG)
Meeting
- Nov 3 - 5 - Eastern Cooperative Oncology Group (ECOG) Meeting
- Nov 7 -8 - Clinical Trials Summit
- Nov 14 - PRIM&R Community Member Training
- Nov 15- 17 PRIM&R Annual Meeting
- Dec 14-17 San Antonio Breast Cancer Symposium
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Difference!
If you believe in the hope of research and the power of
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donation. RAN is an
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Editors and Authors: Elda Railey, Mary Lou Smith, Judy
Perotti
Special contributing author: Cheya Pope
Network News is currently published 10 times per year and includes articles
on advocacy,
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