History and context
Canada has a rich history in ALS clinical trials. Though an ALS research community developed here alongside the rest of the world in the late 1970s and 1980s, Dr. Andrew Eisen at Vancouver General Hospital is widely regarded as the first ALS clinical trialist in the country, leading a double blind, placebo-controlled study of lamotrigine in the early 1990s. At that time, most clinical trials were performed at a single site and were academically driven, which means the clinician conceives the idea, designs the study, and often pays for it with a limited research grant.
However, as the 1990s progressed, an informal network of Canadian ALS clinicians began collaborating and participating in trials that included testing treatments in partnership with pharmaceutical companies. In industry-supported trials, the company designs the study, often in conjunction with clinicians, and pays for the sites to perform the testing. Pharmaceutical company funding allowed for larger, multi-centre, and multi-national clinical trials that could provide more robust statistical analysis to determine if something works or not. Unfortunately, through the 2000s, our still nascent understanding of ALS limited the number of companies willing to invest in ALS clinical trials and only a handful were developing treatments at any one time.
The network of ALS clinics to support clinical trials across Canada was formalized in 2008 as the Canadian ALS Research Network (CALS) through a collaboration with ALS Canada and under the initial leadership of Dr. Lorne Zinman at Sunnybrook Hospital in Toronto. The establishment of CALS was bolstered by a collaborative clinical trial of lithium chloride with the Northeast ALS Consortium (NEALS) in the United States, a study that ultimately failed, but visibly solidified the network for wider engagement in clinical trials run by pharmaceutical companies. By 2012, Cytokinetics had selected 12 sites across Canada to participate in the BENEFIT-ALS clinical trial of tirasemtiv, and CALS clinics have since participated in more than 20 different industry-sponsored studies over the past decade.
Where we are today
ALS Canada plays an important supportive role in bringing new experimental and proven treatments to Canada. By establishing early relationships with industry who are invested in clinical development of new treatments, ALS Canada helps to facilitate connections with Canadian ALS clinical trial sites and strives to continually keep Canada on every company’s radar. Whether we are advocating for a promising experimental treatment to be tested in Canada during the next trial phase or creating relationships to keep Health Canada top of mind should a company demonstrate efficacy in a trial elsewhere, the work is always ongoing to advocate for Canadians to have faster access to effective treatments.
As of 2022, Canada joins countries like the United Kingdom and Italy as top tier clinical trial sites behind the United States for testing the most promising experimental therapeutics from Phase 1 to Phase 3. This comes not only from having world-class clinics and ALS specialists, but also a long-term collaborative investment in infrastructure that supports trial access and capabilities. Canada has a large ALS research community with strong and varied expertise that can support enhancements like biomarker studies, CAPTURE ALS— a cross-Canada platform for biomarker discovery and better understanding of the differences between people living with the disease that is designed to support collaboration with pharma —and the Canadian Neuromuscular Disease Registry, which has become a very exciting resource for post-marketing real world evidence analyses.
Despite all of this, there are still things we can do to improve Canada’s standing as a primary destination for the most promising clinical trials. Pharmaceutical and biotechnology companies who wish to test their treatment in ALS have many important considerations when deciding which countries and clinics they want to work with to run their clinical trials. One of the key considerations is the capacity to recruit participants, as the faster this happens, the better; for them and everyone. When meeting with industry, ALS Canada highlights the value of our world-class clinicians and clinics, the CALS Network and our organization’s role as a central facilitator, but we are only able to look to past recruitment numbers and reputation to extrapolate the demand on the part of Canadians to contribute to research. Moving forward, having a tangible indication of this enthusiasm to relay will only strengthen the desire for companies to do their research here and to consider Canada a primary market for their treatment once proven.
It’s also not lost on ALS Canada that there are disparities in clinical trial access depending on where someone lives. The Clinical Research Fellowship is offered annually to support a young neurologist to focus their efforts on ALS care and research, building capacity in ways that can also support underserved areas to access clinical trials. Dr. Kerri Schellenberg, the current Chair-Elect of the CALS Network and the first recipient of this fellowship in 2007, has brought clinical trials and multidisciplinary care to Saskatchewan for the first time. With additional support the collaboration of ALS Canada and CALS could also pursue creative ways of advocating for trials nationwide such as virtual trials or supporting clinics differently to enhance trial capabilities.
Take Action
This ALS Awareness Month, ALS Canada is asking you to raise your hand in support of more opportunities to participate in ALS research and a desire to see Canada as a “must have” destination for industry in their future trials.
Share this blog post and our social media posts this June to raise awareness within your community about clinical trials and the work ALS Canada does as it relates to ALS clinical trials.
Our understanding of ALS is evolving at a rapid pace, and the resulting experimental treatments now being developed, based on stronger ALS science, are expected to have a greater potential for efficacy. By helping us create Canada as a clinical trials destination, our clinicians will have more opportunities to host the most promising studies. Further investment in clinical development in Canada will also support longstanding efforts to start, maintain and bring back clinical trials to underserviced regions of the country such as British Columbia, Manitoba, Nova Scotia, and more. Building capacity nationwide will enhance opportunities for all Canadians and has always been an important goal for both the CALS Network and ALS Canada.
Help us strive towards a goal of equitable, affordable, and timely access to the most promising experimental and proven ALS treatments available.