Public Release of Alzheimer's Clinical Trial Data By Pharmaceutical Researchers
First Combined Pharmaceutical Trial Data on Neuro-degenerative Diseases; Shared Resource from Unique Public-Private Partnership Will Help Accelerate Alzheimer's, Parkinson's, and Other Brain Disease Research
WASHINGTON, June 11 /PRNewswire-USNewswire/ -- A new database of
more than 4,000 Alzheimer's disease patients who have participated
in 11 industry-sponsored clinical trials will be released today by
the Coalition Against Major Diseases (CAMD). This is the first
database of combined clinical trials to be openly shared by
pharmaceutical companies and made available to qualified
researchers around the world.
It is also the first effort of its kind to create a voluntary
industry data standard that will help accelerate new treatment
research on brain disease, as patients with other related brain
diseases are expected to be added. The level of detail and scope of
this database will enable researchers to more accurately predict
the true course of Alzheimer's, Parkinson's, Huntington's, and
other neuro-degenerative diseases, thereby enabling the design of
more efficient clinical trials. Patient identifiers will not be
included in the database, thereby ensuring patient privacy.
CAMD is a formal consortium of pharmaceutical companies,
research foundations and patient advocacy/voluntary health
associations, with advisors from government research and regulatory
agencies including the U.S. Food and Drug Administration (FDA), the
European Medicines Agency (EMA), the National Institute of
Neurological Disorders and Stroke (NINDS), and the National
Institute on Aging (NIA). CAMD is led and managed by the non-profit
Critical Path Institute (C-Path), which is funded by a cooperative
agreement with the FDA and a matching grant from Science Foundation
Arizona.
"The U.S. Food and Drug Administration has supported and
actively participated in this innovative and unprecedented
public-private partnership from its inception," said Joshua
Sharfstein, MD, Principal Deputy Commissioner, FDA. "The agency is
strongly committed to CAMD and other regulatory science
collaborations that can speed safe and effective treatments to the
public."
In addition to sharing data, the pharmaceutical members of CAMD
have agreed to use the new common data standard established for
Alzheimer's disease by the standard-setting organization, CDISC, in
their future submissions for drug approvals. The Clinical Data
Interchange Standards Consortium (CDISC) is a global,
multidisciplinary, non-profit organization that has established
standards to support the acquisition, exchange, submission, and
archive of clinical research data and metadata. CDISC standards are
vendor-neutral, platform-independent, and freely available via the
CDISC website. This will add greater efficiencies to the FDA's
review process and make it possible for new products to reach the
market more quickly and with greater assurances of safety and
effectiveness.
"This unprecedented data sharing is game-changing for companies
that are developing new therapies for neuro-degenerative diseases,"
said Raymond Woosley, MD, PhD, President and CEO of Critical Path
Institute (C-Path). "Scientists around the world will be able to
analyze this new combined data from pharmaceutical companies, add
their own data, and consequently better understand the course of
these diseases."
Mark McClellan, MD, PhD, who launched FDA's Critical Path
Initiative during his tenure as FDA Commissioner, also noted the
need for better evidence. "Too many treatments fail in the last
stages of research, wasting millions of dollars and years of
research time. To get to faster, more efficient development of safe
and effective treatments, we must have a better understanding of
diseases at the molecular level. The CAMD database is a promising
step in this process for neurodegenerative diseases," said Dr.
McClellan, who is now the director of the Engelberg Center for
Health Care Reform and Leonard D. Schaeffer Chair in Health Policy
Studies at the Brookings Institution.
Roughly 6.5 million people in the U.S. are afflicted with
Alzheimer's and Parkinson's diseases, with costs reaching as much
as $175 billion annually. Worldwide there are already an estimated
30 million people with dementia alone. By 2050, the number will
rise to over 100 million. Halting or slowing the progression of
these diseases will prevent untold suffering and save tens of
billions of dollars every year.
"Data sharing is the backbone of several CAMD projects designed
to identify patients who might develop brain diseases, i.e., before
symptoms are apparent," said Marc Cantillon, MD, Director of
C-Path's Coalition Against Major Diseases. "Our goal is to develop
tools to prevent or slow these diseases so patients can maintain
independence and quality of life."
The CAMD database will allow researchers to design more
efficient clinical trials that have the maximum chance of
demonstrating if a new treatment is truly safe and effective. In
addition, the coalition is identifying biomarkers that identify
patients in the very early stages of Alzheimer's disease and
Parkinson's disease.
According to Maria Isaac, MASc, MD, PhD, Scientific
Administrator, Scientific Advice, Human Medicines Special Areas
Sector of the European Medicines Agency (EMA), "Within the context
of the Innovative Medicines Initiative (IMI) in Europe, the EMA is
committed to similar goals as C-Path's consortia, i.e., to help
biopharmaceutical drug development, for the benefits of patients.
The Agency is especially interested in reviewing CAMD's Alzheimer's
biomarkers and disease progression models."
Frank Casty, MD, VP Technical Evaluations, AstraZeneca
Pharmaceuticals LP, and Co-Director of CAMD said, "AstraZeneca
strongly believes that a healthier world must come from
collaboration, in making better, deeper connections with all our
stakeholders, and sharing skills and ideas to meet a common goal -
improved health."
CAMD Members: Abbott, Alliance for Aging Research, Alzheimer's
Association, Alzheimer's Foundation of America, AstraZeneca
Pharmaceuticals LP, Bristol-Myers Squibb Company, CHDI Foundation
Inc, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Forest
Research Institute, Genentech Inc., GlaxoSmithKline, Johnson &
Johnson, National Health Council, Novartis Pharmaceuticals
Corporation, Parkinson's Action Network, Parkinson's Disease
Foundation, Pfizer, Inc., and sanofi-aventis US Inc.
About CAMD: CAMD members fully share pre-competitive data and
knowledge that will more efficiently and safely speed development
of new therapies and preventions for Alzheimer's, Parkinson's,
Huntington's, and other debilitating neuro-degenerative diseases.
CAMD's overall objective is to help scientists identify clinical
and laboratory characteristics of patients who are pre-symptomatic
and most likely to benefit from new therapies. For more information
on CAMD and the database, visit http://www.c-path.org/CAMD.cfm.
About Critical Path Institute (C-Path): An independent,
non-profit organization, C-Path's mission is to serve as the
impartial facilitator of collaborative efforts among scientists
from government, academia, patient advocacy organizations, and the
private sector to support the U.S. Food and Drug Administration's
regulatory science initiatives. This involves creating faster,
safer, and smarter pathways for innovative new drugs, diagnostics,
and devices that will significantly improve public health.
Established in 2005, C-Path is headquartered in Tucson, Arizona,
with offices in Phoenix, Arizona, and Rockville, Maryland. Visit
www.c-path.org for more information.
Source: Coalition Against Major Diseases
CONTACT: Mike McGill, cell: +1-443-995-9144, mike@turnerstrategies.com
,
or Suzanne Turner, cell: +1-202-744-9161, suzanne@turnerstrategies.com,
both
of the Coalition Against Major Diseases
Web Site: http://www.c-path.org/CAMD.cfm
Posted: June 2010
