To your health and prosperity: A
year in clinical trials
To Your Health and Prosperity – An Action Plan to Help Attract More Clinical Trials to Canada is the result of the first ever National Clinical Trials Summit that took place nearly year ago, on September 15, 2011. The Summit was co-sponsored by the Canadian Institutes of Health Research (CIHR), the Association of Canadian Academic Healthcare Organizations (ACAHO) and Canada’s Research-Based Pharmaceutical Companies (Rx&D). Implementation of the action plan is now underway.
At the Summit, over 100 experts from academia, healthcare, government and industry met to discuss how Canada could reclaim human, social, and economic benefits of clinical trial investment, which it is currently losing to comparator countries. The premise was that by improving the cost, quality, speed and relationships involved in starting and operating clinical trials, Canada could offer a more attractive value proposition for clinical trials. The Summit delivered over 40 action items from which the following nine broad action plan recommendations evolved:
1. A national headquarters for clinical trial activities: The action plan’s first and pivotal recommendation is the establishment of a national headquarters to oversee its implementation and serve as a coordinating mechanism for regional and domain-specific clinical trial improvement activities. CIHR is leading the next steps in this area.
2. Measuring, monitoring and marketing progress and performance: The second recommendation is to track and clearly communicate progress. Several groups, including Rx&D, are studying the types of metrics that are needed in this regard. Next steps are therefore to bring experts together to develop key indicators for national implementation.
3. A bold long-term vision for health and research: While the action plan’s operational recommendations are good starting points, clinical trials require robust healthcare and research ecosystems. Recommendation 3 captures this relationship, which is a longer term issue at the heart of many organizations’ strategic and advocacy efforts.
4. Protecting people and promoting research through ethics reviews: While Canada is known for its ethical vigilance in research involving humans; many experts in the ethics review community believe this can be maintained while improving efficiency. An expert committee under CIHR has been struck to examine issues related to the harmonization of application and consent forms, as well as multi-organizational reviews.
5. Patient recruitment: Recruiting patients for clinical trials is complex in a small population like Canada’s. The action plan calls for the development of a national patient recruitment strategy and the development of patient databases. Progress on this file is anticipated in the coming year.
6. Efficiency and trust with standards, training, and certification: Using similar Standard Operating Procedures and training modules, such as those developed by the Network of Networks (N2), can reduce uncertainty for sponsors wishing to set up studies in different organizations. Next steps are to help expand availability, use, and awareness of such resources.
7. Getting to Yes –a model Clinical Trial Agreement (mCTA): The mCTA is a template contract that was proposed by members of ACAHO and Rx&D, through funding from CIHR. Its goal is to facilitate negotiations between clinical sites and trial sponsors. Over the past year, CIHR has led a pilot study on the mCTA that recently ended. During this time, provincial bodies and pilot participants made outstanding efforts to bolster its progress. The pilot report and next steps are expected this fall.
8. Communicating Canada’s clinical trial assets: In a unique initiative involving members of industry, academic healthcare organizations and government, including CIHR, the Department of Foreign Affairs, Industry Canada, Health Canada and ACAHO, Rx&D is leading the development of a clinical trials asset map for Canada. This will allow a one stop web-based shop to communicate key healthcare information to global sponsors.
9. Maximizing incentives – intellectual property (IP) and tax policy: Finally, Rx&D is working on the summit’s recommendation to advance policies that pertain to IP and tax credits. By bringing Canadian IP protection up to levels already present in the European Union and elsewhere, a more secure and internationally competitive environment can be created that will attract global investment into Canadian clinical trials.
The Clinical Trials Summit Action Plan has garnered support from many diverse groups that believe that Canada can reclaim the many benefits that are derived from clinical trials. Next steps, details and updates will be forthcoming in the months ahead. Readers can visit www.acaho.org or www.canadapharma.ca for a copy of the plan, background materials, and further reading.