Cannabis Clinical Trials: Achieving Compliant Health Claims

Cannabis Clinical Trials: Achieving Compliant Health Claims

October 3, 2018 By

Every day, we take for granted the medical treatments offered by our physicians for illnesses like hypertension and epilepsy. If medical professionals and the pharmaceutical industry did not invest in clinical research over fifty years ago, there would be little to no progress in discovering suitable treatments or possible cures for any disease. In recent years, most of the public has been concerned about living a healthy lifestyle, and the search for alternative therapies continues to rise. Clinical research and clinical trials have established the efficacy of many natural remedies and supplements. With Canada’s Cannabis Act now in force, nutraceutical companies have a hot new opportunity in cannabis clinical trials, to serve today’s health conscious public.


Inhale the Benefits, Exhale the Stigma


Clinical trials are a fundamental tool for the cannabis industry, to break through the stigma that was created by the prohibition of marijuana in 1937 (The Marijuana Tax Act of 1937, USA). Prohibition has hindered clinical advances in the United States, Canada and Europe.

The only way to measure the efficacy of a treatment is to test it on willing patients. However, clinical trials have a stigma; human guinea pigs, unknown side effects, experimental treatments, and endless testing are some of the misguided impressions that people have about clinical trials. The truth that most people fail to consider when it comes to clinical trials is that every medicine or medical device, from ibuprofen to pacemakers, have been fully tested through closely monitored, highly regulated clinical trials in order to ensure safety and efficacy.

Clinical trials are monitored by many regulatory bodies. For cannabis clinical trials though, the application process may stall. In the United states, the FDA classified cannabis as a Schedule I controlled substance (under the Controlled Substances Act). This classification provides researchers with investigator/protocol restrictions, with Schedule I-level security requirements. The NIDA (National Institute on Drug Abuse) provides research-grade marijuana for clinical research. NIDA is responsible for overseeing the cultivation of marijuana for medical research, and has contracted the University of Mississippi to grow it for research at a secure facility.


Conduct Your Cannabis Studies in Canada


What all this means is that there is only one legal institution that provides cannabis for clinical trials in the US. In Canada, under the Cannabis Act, different types of licences are required to grow, cultivate, import, export, test, and research cannabis. Even though Health Canada’s Research Ethics Board monitors every aspect of a trial, it is much more accessible to execute your clinical trial in Canada.

Whether your company is based in the USA, Europe or Canada, dicentra can help you get your cannabis clinical trials approved in Canada, saving you time and resources.

Fourteen institutions have been awarded a combined total of $1.4 million by the federal government in Canada to complete a wide range of cannabis research projects aimed at helping Canadians understand the impact of the legalization of marijuana, and any benefits that may come from it. Canada is investing in its people and their well-being. Recent clinical trials from around the world have concluded that cannabis is a safe and effective treatment (to be used in conjunction with classical therapies if applicable) for chronic pain, Crohn’s Disease, epilepsy, PTSD, improving appetite in HIV/AIDS, and so on. More trials need to be done to see the extent of this plant’s medicinal powers and to appreciate all that it has to offer.


Cannabis Clinical Trials – Step by Step


If you are considering making health claims on your cannabis products, or would like to show the public how effective your CBD oil is, now is an ideal time to start considering and planning a clinical trial. We can help you write up protocols, find an investigator to oversee your trial, and get you cleared through all the regulatory hurdles along the way. Let’s talk about the future of medicine and how your cannabis product can be used to advance it with a clinical trial! Our clinical team has the answers you are looking for.


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dicentra Cannabis Consulting is committed to keeping you well informed and educated on the Cannabis Act and the cannabis regulatory framework. We are committed to providing you with news, updates and information as the Cannabis Act and the Cannabis Regulations come into force on October 17, 2018 and into the future.