The Canadian Clinical Trials Coordinating Centre (CCTCC) was created to implement an action plan to strengthen and improve clinical trials in Canada and streamline processes for companies and researchers. Developed through extensive stakeholder consultation, the action plan includes nine key recommendations to improve the coordination of clinical trials in Canada, increase participation in trials, and strategically raise Canada’s profile among international companies. Those recommendations are summarized in the report “To Your Health and Prosperity – An Action Plan to Help Attract More Clinical Trials to Canada.”
Action Plan Achievements
The CCTCC has achieved the following outcomes in relation to the recommendations contained within the action plan.
Recommendation 1 - Establish implementation and coordination headquarters and resources:
Preferably by leveraging the capacity of an existing forum (Rx&D and ACAHO are recommending alignment with the CIHR Strategy for Patient Oriented Research if possible), establish an implementation committee and resources that would oversee and enable implementation of this action plan and that could coordinate, link and leverage different activity types and inter-provincial clinical trial improvement activities.
Update: A CCTCC Advisory Group was established, comprised of experts in the clinical trials field from across Canada. The Advisory Group provided timely advice, support and input on CCTCC projects and initiatives.
Update: CCTCC facilitated joint meetings of provincial clinical trial organizations to foster collaboration and project engagement, identify emerging issues and challenges in Canadian clinical trials field and reduce the duplication of efforts.
Drawing on available datasets, select and collect meaningful and parsimonious metrics on clinical trial performance and return-on-investment that allow Canada to: (a) measure, monitor, and discuss progress; (b) identify issues; and (c) demonstrate return on investment for sponsors, sites, and all levels of government.
Update: CCTCC has gathered clinical trial metrics in the following areas to assess Canada’s performance:
Investment metrics: total investment in clinical trials in Canada and how we compare to our global competitors
Operational metrics: timelines for contract and budget negotiations, and research ethics boards
Quantitative metrics: number of new trials, newly opened sites, patient recruitment, and the high quality of clinical trial data in Canada
Recommendation 3 - Integrate health system & research infrastructure to ensure quality & sustainability:
Espouse a bold vision for the integration of research and health care. This would ensure sustainable infrastructure, staffing, resources, and career support for the generation To Your Health & Prosperity…An Action Plan to Help Attract More Clinical Trials to Canada and integration of research. It would also ensure receptor capacity to improve patient care, population health and the economy as per the broader Strategy for Patient Oriented Research and recommendations from the National Task Force on the Future of Academic Health Sciences Centres.
Leveraging the appropriate bodies and expertise undertake a feasibility assessment and proposal for a common application form, consent form template, elements of an accreditation system, and information sharing mechanisms for ethics reviews. Also support the work of Health Canada in evaluating standards and accreditation options.
Update: CCTCC, in collaboration with Health Canada, established the Research Ethics Board (REB) Accreditation Working Group (WG) to identify strategies to improve the efficiencies of ethics reviews for REBs that review clinical trials. The REB WG released its final recommendations. CCTCC and Health Canada are now following up on these recommendations.
Recommendation 5 - Develop a ‘database of registries’ & consider a national patient recruitment strategy:
Improve patient recruitment times by developing a database of registries with appropriate consent and privacy considerations that will help to identify patients that may be eligible for clinical trial participation. Identify, implement and share tools that have proven effective for this purpose. This will improve recruitment rates and speed.
Update: The British Columbia Clinical Infrastructure Network (BCCRIN), in collaboration with CCTCC, developed the Pan-Canadian Survey on Clinical Trial Participation to gather information from patients about their experiences with clinical trials and what motivates them, or not, to participate. Results, expected in mid-2017, will inform Canadian clinical trial practices on patient communication, engagement, outreach and study protocol design.
Update: The CCTCC’s Patient Registries Project is gathering descriptions and contact information for active patient registries to input into the Canadian Clinical Trials Asset Map (CCTAM) to assist with patient recruitment.
Recommendation 6 - Adopt common Standard Operating Procedures (SOPs), training and certification:
Fund and leverage the Network of Networks (N2) to help disseminate common SOPs and Training resources. Work with N2, ACAHO, Rx&D, CIHR and other interested parties to develop a site certification approach to identify organizations that have these standards and training in place.
Recommendation 7 - Improve and use the common clinical trials contract:
Implement the model Clinical Trials Agreement (mCTA) currently being pilot tested by CIHR, Rx&D and ACAHO, ensuring that the proper adjustments are made after the pilot and that appropriate communication and dissemination occurs, including to global head offices if necessary.
Update: A standard model contract (mCTA) for use by clinical trial sites and sponsors in negotiating phase II and phase III clinical trial agreements has been developed. Having a standard contract will streamline the negotiating process, expedite trial start up times and give Canada a global advantage.
Update: Awaiver has been negotiated that exempts Canadian hospitals from completing Form 1572 – a form required by US pharmaceutical companies that investigators will comply with FDA regulations.
Advocate to bring intellectual protection (IP) policy to levels commensurate with Europe within the Canada-European Union Comprehensive European Trade Agreement (CETA). Help to improve administration of Scientific Research & Experimental Development (SR&ED) tax credit so that credits are received in time to offset costs of trials. Ensure that global head offices are aware of these improvements once they are made.
Recommendation 9 - Signaling our interest globally - open a concierge (storefront) service for investors:
Start by providing international companies with information on Canada’s clinical trial assets, offerings and improvements, then develop a concierge (storefront) service that would provide a centralized access and information point to global companies.
Update: Creation of the Canadian Clinical Trials Asset Map (CCTAM), a robust, online, searchable database designed to communicate Canada’s clinical research strengths to all stakeholders, including clinical trial sponsors. Its purpose is to:
Better enable sponsors of clinical trials to identify clinical research sites and investigators, and facilitate the conduct of feasibility assessments.
Become a comprehensive database for all Canadian clinical research assets; the essential tool for anyone planning to conduct clinical research in Canada.
Position Canada as an attractive destination for the conduct of clinical trials in the global marketplace.
Update: CCTCC developed an investment case titled “Clinical Trials: The Canadian Advantage”, that provides an in-depth, concise narrative of Canada’s advantages as a clinical trial destination in terms of speed, quality and incentives as well as its unique characteristics, such as an ethically-varied population with access to universal health care.
In addition to the projects directly associated with the action plan’s recommendations, the CCTCC also developed the Fair Market Value (FMV) Project. Representatives from sponsors and sites have come together to develop more effective and efficient budget-negotiation processes. This initiative is not directed at controlling cost, but at providing tools and resources for a more streamlined and efficient process for finalizing budgets for clinical trials. Work is still ongoing for this project.