“Preferably by leveraging the capacity of an existing forum (Rx&D and HealthCareCAN are recommending alignment with the CIHR Strategy for Patient Oriented Research (SPOR) 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.”
“Select and collect a parsimonious set of metrics on clinical trial performance and return on investment that allow Canada to: 1) measure, monitor and discuss progress, 2) Identify issues; and 3) demonstrate return on investment for sponsors, sites and all levels of government”.
3. Integrate health system and research infrastructure to ensure quality and sustainability:
“Espouse a bold vision for the integration of research and healthcare that would ensure sustainable infrastructure, staffing, resources, career support for the generation and integration of research to improve patient care, population health and the economy. This would include the goals of the broader Strategy for Patient-Oriented Research (SPOR) and recommendations of the National Task Force on the Future of Academic Health Science Centres to bolster receptor capacity.”
4. Improve efficiencies of ethics reviews and advance strategic issues (like accreditation):
“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/form sharing mechanisms for ethics review. Also support the work of Health Canada in evaluating standards and accreditation options and explore strategic issues like accreditation and harmonization”.
5. Develop a database of registries and 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.”
6. Adopt common Standard Operating Procedures (SOPs), training, and certification:“Adopt common Standard Operating Procedures (SOPs), training and certification. Establish funding for the Network of Networks (N2) to more broadly disseminate common SOPs and training resources. Work with N2, HealthCareCAN, Rx&D, CIHR and other interested parties to develop a site certification approach to identify organizations that have these standards in place”.
7. Improve and use the common clinical trials contract:
The model Clinical Trial Agreement (mCTA) provides a standard model contract for use by clinical trial sites and sponsors in negotiating phase II and phase III clinical trial agreements. The contract is a response to shared concerns that completing contract negotiations, particularly where the same company is involved with sites in multiple provinces and a master agreement is not in place, complicates the process of bringing clinical trials to patients and puts Canada at a disadvantage globally. The mCTA is a direct response to recommendations from the field for a standard clinical trial template agreement that can help to streamline the negotiating process and expedite clinical trial start up times.
“Advocate to bring intellectual property (IP) protection policy to levels that commensurate with Europe within the Canada-European Union Comprehensive Economic and Trade Agreement. Help to improve administration of scientific research and experimental development (SR&ED) tax credits, so that credits are received in time to offset costs of clinical trials. Ensure that global head offices are aware of these improvements once they are made”.
9. Signaling our interest globally:
“Position Canada as an attractive destination for the conduct of clinical trials in the global marketplace, by providing international companies with information on Canada’s clinical trials assets through a comprehensive, unique, robust, searchable web-based database – the CCTAM (Canadian Clinical Trials Asset Map).”