|
|
 |
Canada – Your Innovation Partner in: Clinical Trials (2006)
| “ Canada is an excellent environment for clinical research. It combines excellent academics and top class researchers with good patient populations, excellent cost structures and
leading R&D; tax credits. In Canada you can reach your recruitment goals, and achieve
extremely high quality research and quick performance with superior economics.“
John Suk, President & CEO, ALTANA Pharma, Oakville, ON
|
|
Why are so many international companies conducting clinical trials in Canada?
|
| |
Canada offers: |
| |
Excellent research
|
| | |
| |
Internationally-recognized clinical researchers and centres
|
| | |
| |
Growing community of qualified clinician-researchers
|
| | |
| |
High standards of reliability in clinical data Nationally-integrated research programs
|
| | |
| |
Strong information management
|
| | |
| |
Well-characterized patient populations
|
| | |
| |
Good record of recruitment
|
| | |
| |
Streamlined regulatory process
|
| | |
| |
Initiatives to centralize ethics reviews
|
| | |
| |
Generous R&D; tax treatment
|
| | |
| |
Competitive costs
|
|
|
Canada is a location of choice for trials by multinational pharmaceutical companies
|
| GlaxoSmithKline conducts more than 150 clinical trials annually in Canada involving some 23,000 patients and over 1,400 centres, and spends more than $140 million annually on R&D; in Canada. |
| |
| Novartis Pharmaceuticals Canada Inc. has over 30 different products in development in Canada. Novartis’ clinical trials involve more than 1,500 Canadian investigators, 2,000 patients and 1,200 different sites across the country. |
| |
| The Canadian operation of the German-based ALTANA Pharma AG family is second only to its German headquarters in leading clinical trials. While ALTANA has 30 subsidiaries around the world, Canada is the site for 10% of its worldwide clinical trial programs. Canada
was the only country chosen for ALTANA’s Exercise-Induced Bronchoconstriction trial. |
|
Make Canada’s strengths work for you!
|
Top-Notch Research
Canada has an excellent track record of basic biomedical research, strengthened by increased funding through the Canadian Institutes of Health Research (CIHR) and through other federal and provincial agencies. CIHR-funded research is integrated and reinforced through the agency’s “virtual
institute” structure. The Canadian research scene includes multi-disciplinary, nationally-integrated clinical research programs in pediatrics, critical care, cardiology, cancer and HIV/AIDS.
Internationally-Recognized Clinical Researchers and Centres
Well-organized large clinical research teams with proven international leadership, along with smaller centres linked through common health system structure and strong information management systems, have helped earn Canada a reputation for meeting recruitment targets and generating
reliable results. Researchers such as Dr. Salim Yusuf and Dr. Herzel Gerstein of McMaster University in Hamilton and Dr. Martin Schecter and Dr. Julio Montaner of the University of British Columbia are well-recognized for their leadership of large-scale international trials. Some key centres for
coordination of large-scale trials include:
|
|
A Growing Community of Qualified Clinician-Researchers
The Canadian Institutes of Health Research, as part of its Clinical Research Initiative (www.cihr-cri.gc.ca), has established the Randomized Controlled Trial Mentoring Program in order to expand Canada’s community of qualified clinician-researchers.
High Standards of Reliability in Conduct and Reporting of Clinical Research
Ottawa-based epidemiologist Dr. David Moher led the development in 1996 of the CONSORT (Consolidated Standard of Reporting Trials) standard (www.consort-statement.org), for use in conducting and reporting randomised trials. Translated into several languages and recommended by the
International Council of Medical Journals Editors, CONSORT has been adopted by approximately 500 health care journals internationally. CONSORT was revised in 2001 through the addition of recommendations about reporting adverse events or side effects.
Canadian trial sites are regularly monitored by Health Canada, the U.S. FDA and industry sponsors and have earned a reputation for reliability.
“Novartis Pharmaceuticals Canada’s R&D; investment in Canada has close to doubled over five years, growing from $33.6 million in 2000 to $65.5 million in 2005. This increase in investment is a clear testimony of Novartis’ confidence in the quality of Canadian
scientists and the Canadian research infrastructure.“
Jean-Marie Leclerc, M.D., FRCP (c) Chief Scientific Officer and Senior Vice President, Clinical and Regulatory Affairs, Novartis Pharmaceuticals Canada Inc., Montreal, QC
|
|
Nationally-Integrated Research Programs
Networks of Centres of Excellence
Canada’s Networks of Centres of Excellence (NCE) program (www.nce.gc.ca) promotes partnerships between university, government and industry. As of 2006, the NCE program includes funding for networks in the following areas: arthritis; genetic diseases;
prion diseases; vaccines and immunotherapeutics; stroke; stem cells; obesity; and allergy, genes and environment. These networks can be powerful tools in advancing clinical research in specific therapeutic areas.
For instance, the Canadian Arthritis Network was instrumental in establishing the Canadian Rheumatology Research Consortium (www.rheumtrials.ca) to conduct clinical trials in new therapies for rheumatoid arthritis.
Other Research Networks
| - |
The National Cancer Institute of Canada (www.ncic.cancer.ca) has a Clinical Trials Group, centred at Queen’s University in Kingston, Ontario, which is funded by the Canadian Cancer Society and encompasses over 80 institutions
across Canada. |
| |
| - |
In Ontario almost 50% of all cancer patients are seen in an organized cancer system of 12 different centres. The provincially-funded Ontario Cancer Research Network (OCRN), (www.ocrn.on.ca), works to accelerate the development and
testing of promising new cancer therapies. |
|
|
Good Record of Recruitment
The UK-based Centre for Medicines Research (CMR) International reports that, with respect to the number of patients enrolled in Phase II/III trials in 2003 – 2004, Canada ranked in the top three core countries for all eight therapeutic areas studied.
Well-Characterized Patient Populations
Canada’s diverse, multi-ethnic population offers broad genetic heterogeneity, while maintaining sub-populations which provide opportunities for examining clinical outcomes over a variety of unique populations.
Well-characterized founder populations are found in Quebec; in Newfoundland and Labrador; and in the Lunenberg, Nova Scotia area.
A substantial proportion of the Quebec population is documented in a central database, and Quebec has leading expertise in genetic statistical analysis.
| “What Canada lacks in population size, it more than makes up for in efficiency. Canadian clinical research sites produce top quality data, and recruit and retain a significant number of patients. As an oncology-specific CRO, Scimega Research has quick access to
well-organized patient populations due to the strong collaborative networks between cancer research and treatment in Canada. Recruitment problems are a major roadblock to accelerating drug development, so this advantage is critical.”
Denise Deakin, President, Scimega Research Inc., Montréal, QC |
|
|
Experienced Contract Research Organizations
Canada’s contract research industry has thrived through a strong base of local clients as well as companies from around the world that are drawn to Canada’s clinical research environment.
Numerous global contract research firms have operations in Canada, including Quintiles, Covance, ClinTrials BioResearch (a division of Charles River Laboratories) and MDS Pharma Services.
Canadian-headquartered CROs, which span the country, have been making a name for themselves both at home and internationally. Examples include NewLab Clinical Research in St. John’s, Newfoundland and Labrador; Genizon BioSciences and Scimega Research in Montréal; Ventana Clinical
Research and Endpoint Research in the Toronto area; and Prime Trials in Vancouver.
|
|
Strong Information Management
| Provincial population-based patient care databases with person-specific contact information; |
| Advances in telehealth; |
| Rapidly-evolving electronic health records capacity supported by investment from Canada Health Infoway (www.infoway.ca); |
| Common standard-of-care that allows for easier integration of clinical trial data over many sites. |
Streamlined Regulatory Process
Submissions to Health Canada to conduct Phases I - III trials are subject to a 30-day default review, with a seven-day review policy for Phase I bio-equivalence trials. Submission requirements between Health Canada and the U.S. FDA are well harmonized.
Ethics with Efficiency
Canada has early-stage initiatives to create centralized ethics reviews, such as the Ontario Cancer Research Ethics Board (www.ocrn.on.ca), the Canadian Brain Tumour Consortium Review Team (www.cbtc.ca) expedited process
and the University of Alberta-based Health Research Ethics Board
(www.hreb.ualberta.ca).
|
“Canada, an important part of a sound global drug development strategy, offers experienced investigators and accessible patient populations concentrated in about a dozen key urban centres.
The Canadian environment for clinical research is cost-effective, in part because of the tax treatment of R&D.; Furthermore, our CRO business in Canada costs less per employee than our U.S. and UK operations, due in large part to Canada’s publicly-financed health care system.”
Wendy Porter, President, Endpoint Research, Mississauga, ON
|
|
Invest in Canadian Life Sciences
