__MAIN_TEXT__
feature-image

Page 22

Clinical Trails in the

CANNABIS INDUSTRY An Emerging Approach

By Andrew Gregg BHSc., RHN, Clinical Scientific Affairs Associate at dicentra Cannabis Consulting

C

linical research involving cannabis has had a challenging history; until very recently (and arguably still) it remains an area of clinical research characterized by historically heavy regulation and seemingly endless regulatory barriers. The small amount of research produced is often limited as a result of these constraints, with final data and literature leaving many wary even still. The clinical research of cannabis has evolved rapidly in recent years, and continues to be an area of significant expansion with an increasing number of countries leading a wave of new cannabis legislation and the subsequent research that is now permitted and, in many cases, required. Health Canada recently announced that over 195 cannabis research licences have been granted to date, and an amended risk-based approach to triage applications has resulted in a significant increase in licensing process speed. Clinical Trials Ontario confirmed in its September report that there are “approximately 60 cannabis research studies currently underway across Canada, more than half of which are taking place in Ontario.”¹ Through its consultation with Canadians last summer, Health Canada sought to gather input and feedback from those who may be interested in purchasing, manufacturing or selling – what it termed, “cannabis health products”² (CHPs). This consultation with industry stakeholders and the public ran from June 13 to September 3, 2019, with no conclusion put forth by Health Canada at this time of writing. “Following the consultation, Health Canada intends to gather external scientific advice on the appropriate evidence standards required to demonstrate safety and efficacy.”² It can be reasonably assumed that conclusive statements 22

Cannabis Prospect Magazine | December 2019

will be released by the agency no sooner than early 2020. It remains to be seen, following the outcome of the consultation and the external scientific advice being gathered now, how emerging regulations will shape the future direction of cannabis research in Canada. With Health Canada now seeking expert opinion on the “appropriate evidence standards required to demonstrate safety and efficacy”² of CHPs and similar cannabis-containing products, what is poised to become one of the largest sectors of cannabis-related clinical research remains largely undefined as these evidence standards of “safety and efficacy” will be the central focus of this research. As clinical trials for cannabis drugs and cannabis use for specific medical indications continue to progress through slow-but-steady pharmaceutical phases in the background, it is these yet-to-be-seen clinical trials that will be required to demonstrate the safety and efficacy of cannabis. That said, nutraceutical ingredient interactions and the mechanisms of action in these novel nutraceuticals will shape the cannabis clinical research landscape most significantly. Advancements in the areas of formulation and delivery will see even more research come as a result of newly-approved classes of cannabis derivative products, cannabis-containing natural health products and dietary supplements. As PwC Canada recently reported, “pharmaceutical companies wanting to develop prescription cannabis products have been forced to focus on specific active pharmaceutical ingredients or API’s (e.g., tetrahydrocannabinol [THC] and cannabidiol [CBD]) to adhere to strict, traditional drug approval pathways. The limitations of this approach are not only that it

Profile for Cannabis Prospect Magazine

Cannabis Prospect Magazine - December '19 - Issue #6  

Cannabis Prospect Magazine is Canada’s premier trade publication for cannabis industry professionals. With six issues to be printed and dist...

Cannabis Prospect Magazine - December '19 - Issue #6  

Cannabis Prospect Magazine is Canada’s premier trade publication for cannabis industry professionals. With six issues to be printed and dist...

Recommendations could not be loaded

Recommendations could not be loaded

Recommendations could not be loaded

Recommendations could not be loaded