In the last decade, there has been a trend towards increasing clinical trial investment in the developing world including Eastern Europe, South America, China, and India at the expense of Canada, the Unites States and Western European countries. The recognition that Canada was losing its competitive edge in attracting clinical trials led to a meeting of stakeholders in 2011 to discuss how best to address the loss of competitiveness.
Over 125 Canadian stakeholders from industry, provincial and federal governments, academia, and health care institutions came together under the umbrella of the Clinical Trial Summit in 2011. The goal was to identify and develop steps to address the most pressing issues responsible for Canada’s loss of competitiveness in attracting clinical trials. The summit was organized through a partnership between industry (Innovative Medicines Canada), government (the Canadian Institutes of Health Research), health care organizations, and hospitals (HealthCareCAN).
The first part of this article provides an in-depth discussion of the trends that led to the need for a Clinical Trial Summit and the concrete action plan that was developed to enhance Canada’s ability to attract clinical trial investment. A key part of the action plan was the creation of the Canadian Clinical Trials Coordinating Centre (CCTCC). The CCTCC was created with a goal to improve operational efficiencies in the clinical trial field in Canada and promote the country as a destination for clinical trials.
Part II of this article describes the key CCTCC initiatives the organization has undertaken, including the launch of the Canadian Clinical Trials Asset Map (CCTAM) and the development of a Model Clinical Trials Agreement (mCTA). Part II also provides an overview of the other ongoing national and provincial initiatives for strengthening the Canadian clinical research environment.
Canada’s Advantages and the Clinical Trial Summit Action Plan
Canada has numerous advantages that have made it one of the world leaders in clinical research and a leading destination for global clinical trials. These advantages include world-leading researchers and research institutions, high quality clinical trial data, fast regulatory approvals for clinical trial applications (CTAs) [Figure 1], low costs compared to other G7 countries [Figure 2], favorable tax treatment for research and development investments, and one of the most ethnically diverse populations in the world.
Figure 1: Health Canada Therapeutic Products Directorate (TPD) Clinical Trials Applications (CTA) Proportion of Reviews that met the 30 Day Approval Target (1)
Figure 2: Comparing the Costs of Conducting Clinical Trials Across the G7 Countries relative to the United States (US) with US = 100 percent (2,3)
While Canada continues to benefit from these advantages, there is increasing global competition for clinical trials. Over the last 10 years, it appeared that Canada was losing its competitiveness in terms of attracting clinical trials. Canada showed a marked decline in its relative growth rate for industry-sponsored clinical trials between 2002 and 2006, and in 2011, Health Canada reported progressively lower numbers of CTAs in Canada between 2006 and 2010 after excluding CTAs for bioequivalence studies (4).
Global Competition pushing Canada to the fray
In the spring of 2011, Canada's Research-Based Pharmaceutical Companies (Rx&D), now known as Innovative Medicines Canada (IMC), conducted a benchmarking exercise to compare changes in the number of globally funded clinical trials being conducted in Canada between 2005 and 2010 in relation to 16 other countries. Eleven of the 15 largest IMC member companies contributed data for the survey, thus providing a comprehensive overview of the Canadian clinical trials landscape. The benchmarking exercise identified trends that pointed to potential challenges for Canada in maintaining its share of clinical trial activity (3).
In the fall of 2011, over 125 representatives from industry, academia, health care institutions, government, and research networks came together in a summit to develop a pan-Canadian approach to reverse the observed trend in clinical trial activity. This Clinical Trials Summit was jointly organized by the Canadian Institutes of Health Research (CIHR), IMC and HealthCareCAN (formerly the Association of Canadian Academic Healthcare Organizations or ACAHO). The meeting resulted in the development of a nine-step strategic plan (An Action Plan to Help Attract More Clinical Trials to Canada), for making Canada a more attractive location for conducting clinical trials (5). The key elements of the action plan are provided in Figure 3.
|Key Elements of the Nine-Step Clinical Trial Summit Action Plan|
1) Establish a national headquarters and resources for implementation and coordination
2) Establish a process for measuring, monitoring, managing, and marketing improvements in clinical trials performance
|3) Integrate health system and research infrastructure|
|4) Improve efficiencies of ethics reviews and advance strategic issues|
|5) Develop a database of patient registries and consider a national recruitment strategy|
|6) Adopt common standard operating procedures, training and certification|
|7) Improve and use the model clinical trials contract|
|8) Optimize intellectual property protection policy and scientific research and experimental development (SR&ED) tax credits|
|9) Open a concierge (storefront) service for investors|
On Nov 1, 2012, the Senate Standing Committee on Social Affairs, Science and Technology, chaired by Senator Kelvin Ogilvie, published its report, Canada’s Clinical Trial Infrastructure: A prescription for Improved Access to New Medicines (6).
This report emphasized many of the key points from the Clinical Trial Summit Action Plan.
Establishment of the Canadian Clinical Trial Coordinating Centre (CCTCC) in 2014 was an important first step in implementing the recommendations of the action plan. The CCTCC is a unique organization as it was created jointly by CIHR, IMC and HealthCareCAN. Thus, it has representation from industry, government and health care institutions.
The CCTCC’s initial mandate was to implement the nine recommendations of the action plan, with the goals of strengthening and improving clinical trials in Canada, and to streamlining processes for companies and researchers conducting studies in the country.
Currently, in response to the dynamic nature of clinical research globally, the CCTCC initiatives, aimed at introducing operational efficiencies, are a combination of recommendations from the 2011 action plan and more recent needs of the Canadian clinical trials' field. As summarized in Part 2 of this article, the CCTCC has already made significant progress in positioning Canada as an attractive destination for clinical trials.
Shurjeel H Choudhri
Senior Vice President and Head, Medical and Scientific Affairs
Interim Director of Project Facilitation
Canadian Clinical Trials Coordinating Centre
1) Therapeutic Product Directorate’s (TPD) Drug Submission Performance Annual Report Fiscal Year 2014-2015.
2) KPMG Competitive Alternative Highlight. http://www.competitivealternatives.com/highlights/indsummary.aspx?id=886 (accessed 22 September 2014)
3) Investment Case - "Canada - The Clinical Trials Advantage". http://www.cctcc.ca/index.cfm/our-initiatives/investment-case-canada-the-clinical-trials-advantage/ (accessed 26 February 2017)
4) J-M Leclerc, N Laberge, J Marion. Metrics Survey of Industry-Sponsored Clinical Trials in Canada and Comparator Jurisdictions between 2005 and 2010.Healthcare Policy, 8(2) December 2012: 88-106.