Special Report:
The CliniCal Trial landsCape in Canada
late stage clinical trials, new megacentres such as the ones in Québec will increase the potential to attract clinical trials at earlier stages as well.
The Clinical Trial Asset Map
To put Canada on the international clinical trials map, a collaborative effort led by the Canadian Clinical Trials Coordinating Centre is underway to better advertise Canadian researchers and their expertise. With the official launch date set for this June, the Canadian Clinical Trials Asset Map will be an interactive database of Canadian clinical research capabilities to help sponsors easily identify clinical research sites and investigators. In a statement to Biotechnology Focus, Alison Sargent, the executive director of Rx&D’s Health Research Foundation, says, “The overall objective for the CCTAM is to provide a comprehensive picture of the breadth and depth of Canada’s clinical research assets. The CCTAM addresses a gap in the Canadian clinical research resources and mainly, a compressive pan-Canadian one-stop shop tool for all Canadian clinical research resources.”
Patient Engagement and Recruitment
Another critical but often overlooked component of the clinical trials process is patient engagement and recruitment. For Canada, the issue is not so much the time for enrollment, but rather the number of patients enrolled. “There are a significant number of sites that have one, two, five, 10 patients recruited, which means their cost per patient – when you include the site preparation, the monitoring – is very high,” says Soloninka. At the Clinical Trials Summit, it was speculated that the reasons for poor recruitment in Canada may be due to: • Access • Universal health coverage and perception of good care • Lack of trust and knowledge • Inefficient infrastructure • Focus on operational improvements The Canadian Clinical Trial Summit...Starting the Conversation report states that, “Canada has yet to develop targeted resources and strategies to market, explain, and attract patients and the public to clinical trials. This can further result in recruitment, retention, and compliance problems.”5 Unfortunately, since the Summit, there has been limited activity at the provincial or national levels to address this
problem. British Columbia has taken the most progressive steps so far, with a clinical trials participation survey underway that looks at the reasons why people are taking part in clinical trials and, even more importantly, why they are not. The survey recently achieved 600 participants and BCCRIN says it will be presenting the interim results of the survey at the ACRP 2015 Global Conference & Exhibition in Salt Lake City this April. “We’re very excited about this,” Heather Harris of BCCRIN, says. “This is going to give us some really great insights into what’s going on inside clinical trials participants’ heads, so we can better target our engagement strategies, our protocols and consent forms, and things like our behaviour as we’re bringing patients into clinics and welcoming them. It’s really providing some great information.” Additionally, BCCRIN has signed an MOU with CTO to work on issues that are important to both organizations, which includes patient recruitment. The two organizations say they will be launching a public opinion poll about clinical trials within the next few months. To this point, CTO has remained focused on its first strategic priority, which is streamlining the ethics review system in Ontario. Going forward, CTO is turning its attention to patient recruitment and retention. Susan Marlin says the results of this joint survey with BCCRIN will help shape CTO’s patient engagement strategy. Another key development in Canada in terms of patient engagement includes an evolving collection of Permission to Contact (PTC) databases, where patients agree to share personal data and are receptive to being contacted at a later date about relevant trials. The initiation of PTC databases began in some jurisdictions in British Columbia and has since been taken up by other jurisdictions. “We have over 80,000 participants in a PTC database in Canada, and over half of those are in BC,” says Harris. “It’s a real area of strength for us, and something that we’re hoping to move forward with and become a provincial program in BC. Hopefully we can connect with some of the other provinces on this.” PTC databases may play a significant role in mobilizing enrollment processes in the future, especially if stakeholders in Canada can continue to build these databases to include more participants in more areas across the country. Dr. Albert Friesen notes that while recruit-
“(Priorities are) the quality of the researchers and the quality of infrastructure. The upcoming mega centres, SHUN and McGill are really placing Québec at the forefront, I would say, for the next several years, in terms of the potential to attract investments from pharmaceutical companies in Canada.” — Gilles Gagnon, president and CEO of Ceapro Inc. BIOTECHNOLOGY FOCUS April/May 2015
