Though cannabis has been used medicinally around the world for thousands of years, there is still much to learn about it as a drug. And Ontario is helping to lead the way.
There are approximately 60 cannabis research studies currently underway across Canada, and more than half are taking place in Ontario. Research focuses on either cannabis’ effects (dependence, psychomotor impairment, driving impairment related to cannabis) or its impact as a treatment. Disorders being studied include chronic pain (both cancer and non-cancer), epilepsy in adults, epilepsy in children, Tourette syndrome, inflammatory bowel disorders, generalized anxiety disorder, multiple sclerosis and knee osteoarthritis.
“Ontario is a hot spot for clinical trials in cannabis,” says cannabis researcher Dr. W. McIntyre Burnham, a professor emeritus at the University of Toronto and co-director of EpLink, the Epilepsy Research Program of the Ontario Brain Institute (OBI). “Doctors were slow to adopt it because it was banned, but legalization has made cannabis easier to study,” he adds. Recreational cannabis became legal in Canada on October 17, 2018, when the new Cannabis Act came into force.
Showing the world what Ontario can do
Dr. Burnham is a primary investigator in the first study in Canada to examine the impact of cannabis oil on the reduction of convulsive seizures in adults. This phase III, double-blind, randomized, placebo-controlled trial, which looks at CBD (cannabidiol), plus THC (tetrahydrocannabinol) – at a ratio of 16:1, will take about two years to complete.
He and his team are also planning trials of cannabis in complex partial seizures and depression. “We have found evidence that CBD works in animal models of epilepsy and depression. In our lab it is the best thing we’ve ever seen for complex partial seizures, and we’ve been looking for years. It is as good as any of the new anti-convulsants, without the side effects,” he says.
Dr. Justin Grant, Executive Vice President of Scientific Affairs at Avicanna Inc. (TSX: AVCN), a leader in innovative biopharmaceutical advancement using cannabinoids, agrees legalization has provided a legitimacy for cannabis that it didn’t have before. Avicanna is waiting for Health Canada to approve a clinical trial application at a top Toronto-based hospital, for a phase II/III study of a cannabidiol cream to alleviate the painful blisters caused by epidermolysis bullosa [Butterfly Disease] in children. The company has other trials in the pipeline focused on studying the potential benefits of medical cannabis. “Canada is in a unique position to conduct clinical research in the cannabis field. This is definitely a great opportunity to show the world what we can do.”
Clinical trial results will augment real-time data
Meanwhile, real-time observational data is being collected on millions of medical cannabis users. The scale of that information was a key topic at “Innovating in the medical cannabis space,” one of the panel sessions held in Toronto during Medical Cannabis Week in Toronto in May 2019. “This is not an industry where products have been brought to market because there have been clinical trials,” said Andrew Muroff, CEO of medical cannabis company Strainprint Technologies. “The cart was put before the horse.” Strainprint has eight clinical trials on its platform and more than 1.2 million patient-reported outcomes … “the largest data set of its kind in the world today,” said Muroff.
Fellow panelist and innovator John Prentice, CEO of Ample Organics, noted that long-term, standardized research is needed. “Medical cannabis has been available for medical use in Canada since 2001, but only now have we been able to put some dollars behind learning about it.” Ample Organics’ databases contain data on about 80% of the registered medical patients in Canada – more than 400,000 people.
Conducting cannabis clinical trials in Ontario
Heightening the appeal of conducting cannabis clinical trials in Ontario are Clinical Trials Ontario (CTO) programs, designed to help companies expedite their start-up processes, improve efficiency and cost-effectiveness of research, and link to hundreds of world-leading clinician scientists, trial sites and resources.
For companies interested in accessing Ontario’s expertise and conducting clinical trials, CTO can provide valuable introductions to leading clinician scientists and research sites through its free Industry Concierge service. CTO’s online ethics approval system, CTO Stream, allows a single research ethics approval for all sites participating in a multi-site trial. All reviews are conducted by a CTO Qualified REB, ensuring the highest ethical standards are maintained. CTO’s QuickSTART program enables clinical trials sites and industry sponsors to set targets and establish standardized processes to improve efficiency and achieve trial activation within just 90days. QuickSTART is currently accepting trials.
“Medicinal cannabis is a fast-growing market and Ontario is well on its way to becoming a leader in conducting high-quality cannabis trials,” said Susan Marlin, President and CEO of CTO. “As one of the top clinical trials jurisdictions in North America, we have the researchers and infrastructure to conduct efficient and effective trials that will help move new cannabis treatments from bench to bedside.”
To learn more about why Ontario is a preferred location to conduct global clinical trials, watch Why Ontario for Clinical Trials.