At an iPolitics Live event on Tuesday morning, stakeholders in the clinical trials field spoke about how to move Canada from its fourth-place global ranking in carrying out clinical trials, given that we only have a 4.1 percent share of those trials while countries like Argentina, India, China, Hungary and Russia are reducing their own barriers.
“The clinical trial environment in Canada is actually quite favourable,” said Christina Archer, Canadian country head of clinical operations with Roche Canada, in a one-on-one conversation. “Canada is quite conducive to running trials. We have a strong reputation from a science perspective, really strong therapeutic area experts, strong academic institutions, a highly diverse population that is conducive to running trials, as well as a stable healthcare system.”
Archer noted that Roche invested Roche invested $15 million in clinical trials last year, with more than oncology studies taking place. With the increasing complexity in the field, Archer says there is a need to keep up with change from both a policy and legislative perspective, which also includes reducing the bureaucratic hurdles, as well as the barriers of infrastructure and geography.
“There’s a real opportunity to educate and to increase the number of patients who are interested and understanding of what a trial would be and whether it would be the right choice for them,” said Archer.
Following the conversation, a panel discussion took place about what the Canadian landscape looks like and what needs to change in order to advance clinical trials.
Dr. Karen Lee, Vice-President of Research for MS Society of Canada, relayed a story of a ten-year bone marrow trial, and how one patient went from a wheelchair to being able to walk down the aisle of her wedding and return to the workforce.
“That really demonstrates how powerful and transformational clinical trials can be,” Lee said. “It’s really the last hurdle in clinical research to ensure that medical devices, medical treatments or diagnostic tools have passed the safety and efficacy to ensure that these things come to market for the general population.”
Lee said that the most important part of these trials is the patients, which need to be engaged rather than be treated like subjects.
“For many people who live with a disease, [trials are] a possibility of hope, getting early access to a treatment that isn’t currently available on the market, and they’re also going to have a different type of care – they’re going to be more critically followed, and some people want that instead of regular check-ups,” said Lee.
The Canadian Clinical Trials Coordinating Centre (CCTCC) was established in 2014 after stakeholders including Innovative Medicines Canada, the Canadian Institute of Health Research (CIFH) and healthcare institutions represented by HealthCareCAN came together in 2011. All of them recognized that competition from emerging markets was leading to the loss of clinical trials in Canada, but so were the internal problems of costs and the speed of trials.
“Canada produces high-quality clinical trial data, and we also have some advantages in terms of speed,” said Elena Aminkova, interim director of project facilitation with CCTCC. “While start-up could be slow, we are very fast in recruiting first patient after a site has been initiated, and Health Canada regulatory approval times are very fast – 30 business days for phase-3 trials, and seven business for phase-1 trials.”
Aminkova noted that other advantages Canada has include our diverse ethnic population, a highly educated general public, federal and provincial tax credits for clinical trials as well as the positive effects of a low Canadian dollar.
Aminkova said that CCTCC promotes collaboration across the country, helping to avoid duplication of effort and to work jointly to advance projects. With their collaboration, the first pan-Canadian survey on clinical trial participants was being finalized, and they had helped to create a Canadian clinical trials asset map, and they launched a model clinical trial agreement to harmonize efforts around the country.
“Without clinical trials, Canada will continue to lag behind the rest of the world with the introduction, adoption and diffusion of new technologies and drugs,” said Bill Tholl, a senior consultant in health policy and leadership development. “Canada tends to be a laggard, and without leading the world in clinical trials, Canadians won’t be able to take full advantage of that.”
Tholl said that the challenge is to leverage the advantages that Canada has, but not all or our policies are conducive to clinical trials, citing that the fee-for-service healthcare payment model was not the friend of researchers. Tholl said that there needs to be an identification of what trials will offer for patients, and said that the conversation should include the Declaration of Helsinki, an international declaration of protecting patients in enrolling in trials, and post-trials observation.
“As we talk about clinical trials and what we need to do, we always have to understand the best way to value for patients,” said Laura Accettola, director of global study management in oncology with Roche Canada.
Accettola said that greater awareness about clinical trials among the general population is part of what’s necessary to get a greater uptake.
“Oftentimes, patients are overwhelmed with information, especially at first diagnosis,” says Accettola, given her experience in oncology. “The last thing you need to do is start learning about a clinical trial when you’re trying to understand what the best options are for your health.”
Accettola noted that there needs to be more support for physicians at clinical sites, so that there is easier to manage trials at clinical sites, especially when they can’t rely on a steady stream of trials, particularly when it involves rare diseases.