Bedrocan Canada Inc. (“Bedrocan” or the “Company”), a subsidiary of Tweed Marijuana Inc. (TSXV: TWD) (“TMI” or “Tweed”), along with its sister company Tweed Inc., is pleased to announce the launch of the EQUAL (Evaluation QUAlity of Life) study. The clinical research initiative is a multi-centre, non-interventional, un-blinded study to evaluate quality of life in Canadian patients treated with medical cannabis. The company-sponsored study will evaluate patients who use Bedrocan and Tweed strains of cannabis to help manage symptoms of a range of chronic health conditions, and the resulting data will be submitted for publication by a peer-reviewed medical journal. To ensure patient privacy, all data collected will be anonymized and stored in a secure electronic database.
The primary objective of the study, which is intended to continue for three years, include more than 50 sites, and enroll up to 6,000 patients, is to evaluate the quality of life (QoL) of patients before and after treatment with medical cannabis. The study will use a well-established general QoL assessment instrument, the SF-36, and will record both positive and negative effects attributed to treatment.
The study will include patients registered under Health Canada’s Marijuana for Medical Purposes Regulations (MMPR), who use Bedrocan and Tweed strains, and who volunteer to participate. Patients will be compensated for their participation via discounted cost of product used during the period of the study (12 months per patient), and clinical sites participating in the study will receive a nominal fee for the time required to complete and submit subject surveys of a patient.
The study will not include patients from Quebec, for whom a separate, independent research study was launched in May, 2015, as part of the Quebec Cannabis Registry. Bedrocan and Tweed, along with another licensed producer, are supporting the launch of the Quebec Registry via funding provided to the Canadian Consortium for the Investigation of Cannabinoids (CCIC), and the CCIC has provided a grant to the Research Institute of the McGill University Health Centre (RI-MUHC), to support the first year of the Registry’s operations.
“This will be one of the world’s largest studies on the therapeutic effects of medical cannabis, and will generate extremely valuable patient-level data on treatment benefits, risks and side effects,” said Marc Wayne, President of Bedrocan Canada. “Tens of thousands of Canadian patients are currently using cannabis to manage symptoms from conditions ranging from chronic pain, to certain mental illnesses, multiple sclerosis, arthritis, spinal cord injury, HIV/AIDS, intractable forms of epilepsy and other conditions. We are launching this study to advance the science associated with medical cannabis, to provide the medical community with useful insights into its effect on quality of life, and to gather data specific to the effects of Bedrocan and Tweed strains in patients who use our products.”
The principal investigator for the study is Dr. Martin A. Katzman, Director of the START (Stress, Trauma, Anxiety, Rehabilitation and Treatment) Clinic for Mood and Anxiety Disorders, and on faculty at both the Faculty of Medicine, University of Toronto as well as the Northern Ontario School of Medicine (NOSM). Dr. Katzman is also Chair of the Scientific Advisory Board of the Anxiety Disorders Association of Canada and a member of Bedrocan Canada’s Medical Advisory Board.
“As the number of patients using medical cannabis increases, we have an urgent need to add to the body of literature and compile real-world data on who is using medical cannabis, how patients respond to prescribed cannabis, and what it can and cannot achieve as a treatment option,” said Dr. Katzman. “No one in the medical community is recommending medical cannabis as a first-line therapy, but we know it is being used increasingly by patients refractory to conventional prescription drugs, or who cannot tolerate the side effects of conventional therapies. This study will provide the medical community with data we need, to understand how medical cannabis affects quality of life in patients with a number of different diagnoses and treatment regimens.”
The clinical study will be launching with an initial three sites in Ontario and British Columbia: Wellmedica in Woodbridge, Ontario, Greendot Medical Clinic in Brantford, Ontario, and Greenleaf Medical Clinic in Abbotsford, British Columbia. Physicians and clinics who are interested in supporting this option for their patients and would like to contribute to the growing body of evidence for the appropriate therapeutic use of cannabis are encouraged to contact EQUAL@bedrocan.ca or EQUAL@tweed.com for more information.
DSG, Inc., a leading clinical data capture and management company based in Malvern, Pennsylvania, will provide their flagship eCaseLink™ electronic data capture (EDC) and Electronic Patient Reported Outcomes (ePRO) services for the study.
A link to the original press release can be found here.