In a first-of-its-kind real world evidence study led by University Health Network’s (UHN) Dr. Hance Clarke, patients in a new clinical trial will be able to select and track medical cannabis products that are tested, from seed and source through to packaging.
Using TruTrace technology, Canadian retailer Shoppers Drug Mart has partnered with University Health Network in Toronto (UHN) to launch ‘Medical Cannabis Real World Evidence’ (MCRWE), a new ground-breaking study on cannabis and health which will track outcomes with TruTrace validated product for the first time in history.
This novel observational study is targeting a minimum of 2,000 patients who will be followed over a 24-week period. Enrolled patients will have access to certain fully verified products on the Medical Cannabis by Shoppers platform, which have been tested for detailed cannabinoid and terpene profiles.
Using the online portal created by Medical Cannabis by Shoppers, patients will know exactly what is in their product: how many milligrams of THC and cannabidiol are being consumed, and if it works, for them, they can rely on the product being exactly the same, from batch to batch.
“The challenge with the medical use of cannabis is that physicians and patients are unsure of the quality of products being consumed,” says Dr. Clarke, Director of Pain Services, Toronto General Hospital (TGH), and a recognised leader in educating Canadians about chronic pain management and the risk factors of continued opioid use. “For the first time we will have a national repository of data that can provide answers about the effectiveness of these products, to test their claims.”
Patients in the MC-RWE clinical trial will have access to a wide range of products including dried flower, oil extracts, edibles, and, topical preparations through the portal, which is the online platform for the sale of medical cannabis by Canadian retail pharmacy chain, Shoppers Drug Mart.
Organigram will provide cannabis products to Shoppers for use in the tracking program.
“Organigram is proud of our long-standing commitment to our medical cannabis community. From the development of innovative products to the support offered by our patient care team and programs, patients and their needs are at the heart of our medical cannabis business,” says Greg Engel, CEO, Organigram. “We also recognise how critical consistency is to patients and their healthcare providers so we are pleased to partner with Shoppers, providing our medical cannabis products so that they can track them from raw material to finished product, to offer them important, useable product insights.”
Using Trutrace’s StrainSecure™ system, the program collects plant testing data and performs genomic verification in plant batches which are then registered in a blockchain-enabled database for intellectual property protection and strain validation. All information gathered from the plants, including their molecular and chemical makeup, can be tracked via the technology.
Standardized and validated testing of medical cannabis, ensuring consistent quality and efficacy, are critical to the product’s value as a viable treatment option. Likewise, product information such as strain composition and potency can help healthcare practitioners and patients make more informed and confident decisions about their medical cannabis treatment regimens.
As jurisdictions around the world have begun to legalize and adopt cannabis as a medical treatment, there has been an influx of new breeders and growers and a profusion of new cannabis strains, each with a different representation of at least 500 known metabolites. Subtle changes in the chemical expression of various strains, whether by genetic structure or environmental conditions, may have significant clinical effects on the patients using this treatment option. With so many strains available, and with relatively limited information on strain composition or genetic lineage and their relation to their chemical output, patients have little ability to control what they are taking over time.
In the absence of assigned drug identification numbers (DIN) for cannabis products, quantifying the genetics and metabolomics, as well as potency and equivalencies of cannabis products is of interest to producers, distributors, shippers, government agencies, payers, clinicians and patients.
“Maintaining an effective traceability ecosystem about these details throughout the supply chain is a component of providing consistent medicine,” says Engel.
“We need the evidence to help us in prescribing the appropriate validated product, at the right dose, for the right patient,” says Dr. Clarke, a staff anesthesiologist, who is also Medical Director of The Pain Research Unit, and, Director of the GoodHope Ehlers-Danlos Syndrome Clinic at UHN.
“Ensuring quality standards will allow physicians and their patients to be confident about using medical cannabis to treat a wide range of pain-related ailments.”
Source | UHN