Mighty Sources Join Forces
Print
Email![Computers sharing data with the world](http://alzheimersweekly.com/sites/default/files/image/article/2010/760a%5B2%5D.jpg?1277111095 ""“This unprecedented data sharing is game-changing."")
Two giant steps forward were taken this week in the world of dementia research. Three countries joined forces to standardize guidelines and technologies, while 19 institutions agreed to share clinical trial data from 4,000 patients with the greater research world.
4,000 Patients in CAMD's Database
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.”
“We are proud to be a member of this coalition,” said Frank Casty, MD, VP Technical Evaluations, AstraZeneca Pharmaceuticals LP, and Co-Director of CAMD. “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.”
International Cooperation to Establish Uniform Guidelines and Technologies
Representatives of the German Centre for Neurodegenerative Diseases (DZNE), the UK Medical Research Council (MRC) and the Canadian Institutes of Health Research (CIHR) today signed a cooperation agreement that aims to establish and apply harmonised guidelines and technologies for research on neurodegenerative diseases. The lack of common standards so far has made it difficult for researchers to compare and validate research results. Ensuring comparability means that results achieved in laboratories will benefit patients faster. The German, British and Canadian governments support the agreement. At the press conference held after the signing of the agreement in the British embassy today, the representatives of the three governments unanimously emphasized the importance of international cooperation in tackling the challenges presented by an aging society.
All three cooperation partners possess special expertise in various fields ranging from basic to clinical research. The DZNE can contribute special know-how in the area of biomarkers and clinical studies. Prof. Pierluigi Nicotera, Scientific Director and Chairman of the Executive Board at the DZNE, is thrilled that the institution can contribute to the effort: "This cooperation is of great importance for German research on neurodegenerative diseases. We hope to be able to contribute our expertise to develop new strategies to preventing and curing these diseases." Prof. Nicotera emphasised that common technological platforms and the international standardisation of approaches are crucial to facilitating the transfer of fundamental discoveries into patient benefits.
To ensure that the results are applied in clinics as soon as possible, the German Federal Ministry of Education and Research (BMBF) has tasked the DZNE with working closely with university hospitals all over Germany. "The DZNE has intensified research on neurodegenerative diseases in Germany, improved the coordination of efforts and ensured that research is aligned with the requirements of clinical practice," said Dr Helge Braun, Parliamentary State Secretary at the BMBF. But he pointed out that international partnerships are needed to solve the scientific and clinical issues regarding dementia. "Therefore we wholeheartedly applaud the pooling of resources across borders. The partnership between the MRC, CIHR and DZNE sets new international standards," State Secretary Braun said at the press conference in Berlin. The British and Canadian governments also support the partnership. The two countries were represented by Christopher MacLean, Commercial Counsellor at the Canadian embassy, and British Ambassador Sir Michael Arthur, who said: "I am delighted that the UK - represented by the Medical Research Council - is participating in this international partnership. In a time of increasingly aging societies, new preventative strategies and innovative therapies for the treatment of neurodegenerative diseases are becoming more and more important."
The Medical Research Council has injected significant funding to neurodegenerative research since that this area was reorganised in 2008. "We welcome this exciting opportunity to join with aligned activities in Germany and Canada," said Prof. Chris Kennard, Chair of the MRC Neurosciences and Mental Health Board. "It's through first-class international partnerships such as this one that we will build on our knowledge base and accelerate our understanding to more rapidly combat these debilitating neurodegenerative diseases." Prof. Kennard went on to say that the links between the respective centres of excellence will create an international network that will enable them to attract the best scientists, provide access to cutting-edge technologies, standardise methods and their application and promote the highest level of quality in international research. The MRC can contribute a wealth of experience in working with animal models. Even at the basic research stage, standardised models and methods are crucial to ensure that findings can be compared.
The CIHR conducts both basic and clinical research and is working to standardise imaging methods and the evaluation of the images they generate. "The Government of Canada is pleased to be part of this joint program between national Centres of excellence to establish and validate new technologies in neurodegenerative disease research," said the Honourable Leona Aglukkaq, Canada's Minister of Health. "We understand the importance of working together to ensure uniform global standards and hope our efforts will help treat people who live with neurodegenerative diseases. I commend CIHR for its leadership in developing this initiative."
"We are proud to work with our colleagues in Germany and the UK to fund research addressing neurodegenerative disorders, in particular on Alzheimer's disease. We firmly believe that it will require a concerted global research effort to better understand these disorders, improve diagnosis and treatment, and ultimately find a cure for diseases that affect millions of people," said Dr Rémi Quirion, Executive Director of the International Collaborative Research Strategy for Alzheimer's Disease at the Canadian Institutes of Health Research.
To reach their goals, each of the three centres will allocate €1 million. This will serve as starting capital to finance various measures in the three centres. In addition to workshops and the compilation of guidelines, the money will also be specifically used to fund projects in the centres that work according to these guidelines and methods and will advance the research field as a whole. Reactions to the initiative launched by the three partner institutions have been favourable in other countries, and negotiations are underway with other European research organisations.
Related Videos & Articles
More Information
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.
- Sanofi-aventis US Inc.
CAMD (Coalition Against Major Diseases):
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.
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.
The German Centre for Neurodegenerative Diseases:
The German Centre for Neurodegenerative Diseases belongs to the Helmholtz-Association and is funded by federal and state governments.
The Canadian Institutes of Health Research (CIHR):
For the past 10 years, the Canadian Institutes of Health Research (CIHR) has supported better health and healthcare for Canadians. As the Government of Canada's health research investment agency, CIHR enables the creation of evidence-based knowledge and its transformation into improved treatments, prevention and diagnoses, new products and services, and a stronger, patient-oriented healthcare system. Composed of 13 internationally-recognized institutes, CIHR supports more than 13,000 health researchers and trainees across Canada.
Source:
Critical Path Institute
Canadian Institutes of Health Research
.
