Sapphire Medical Clinics Launches Registry to Expand Medical Cannabis Evidence Base in the UK
Sapphire Medical Clinics Ltd., the first specialized medical cannabis clinic in the UK approved to see patients by the Care Quality Commission, has launched a new initiative aimed at rapidly expanding the available evidence base for medical cannabis.
The UK Medical Cannabis Registry, a new part of the Sapphire Real World Evidence Platform, aims to collect and analyze clinical information from patients taking medical cannabis treatments in the UK for all recognized eligible conditions.
“We are very proud to launch our Real World Evidence Platform which ultimately aims to provide the data to allow patients to access cannabis-based medicines on the NHS for all the conditions in which there is proven clinical benefit,” said Dr Mikael Sodergren, managing director and academic lead at Sapphire Clinics, in a press statement.
“Whilst we are actively involved in setting up randomized controlled trials, our Real-World Evidence Platform will provide faster access to high quality data and will provide an unparalleled resource for clinicians, regulators and commercial stakeholders.”
The UK Medical Cannabis Registry
In March 2020, while announcing a change in import restrictions for cannabis-based medicinal products, the UK secretary of state for health and social care, Matt Hancock, called for more “trials in the UK to accelerate our understanding of how medicinal cannabis can benefit patients” and promised that the government would “continue to engage with medical associations and patients to build evidence”.
In response, Sapphire Medical Clinics announced plans to create the UK Medical Cannabis Registry, which would serve as a database of anonymized real-world evidence covering “all conditions for which there is evidence of clinical efficacy of medical cannabis.”
According to Sapphire’s most recent press announcement, this includes pain conditions (including chronic pain, fibromyalgia, migraine, and others), cancer-related nausea and other cancer symptoms, gastrointestinal conditions, neurological conditions (including epilepsy, multiple sclerosis, and neuropathic pain), and a variety of psychiatric conditions, such as anxiety and post-traumatic stress disorder.
By collecting such comprehensive real-world patient data, the registry aims to allow the medical community in the UK to better analyze the outcomes of medical cannabis use among British patients. It is hoped that this could eventually help in overcoming some of the barriers to access that prospective medical cannabis patients currently face in the United Kingdom.
In recognition of patients’ contribution to the registry in building this database, Sapphire Medical Clinics has also announced that the first thousand patients will be eligible for a significant reduction in appointment cost through the Sapphire Access Scheme.
“There are an estimated 1.4 million medical cannabis patients in the UK and with this initiative we hope to make it more affordable for them to access medication through a recognized clinic where we can carefully monitor their treatment,” said Dr Michael Platt, medical director of Sapphire Clinics, in a press statement.
“Alongside significant patient demand, there is a need to provide clinicians with a prescribing formulary based on the best data available whilst we wait for clinical trials.”
Building a better evidence base for medical cannabis
The UK Medical Cannabis Registry is not the only British effort to improve the understanding of medical cannabis.
Project Twenty21 is an ambitious project created by the UK’s leading independent scientific body on drugs, Drug Science, which aims to enroll 20,000 patients by the end of 2021 into a two-year-long project to create the largest body of evidence on medical cannabis in Europe. The project will predominantly focus on patient populations who have either chronic pain, epilepsy, multiple sclerosis, post-traumatic stress disorder, Tourette’s syndrome, anxiety disorder, or who are dealing with the harms of substance abuse disorders.
The study is not a randomized controlled clinical trial – all enrolled patients will be receiving medical cannabis at an affordable cost; none will be treated with a placebo.
Speaking to Analytical Cannabis last November, Dr Amir Englund, a postdoctoral cannabis researcher at King's College London – who is not involved in Project 21 – explained why randomized clinical trials are generally preferred by researchers.
“There might be all sorts of benefits from cannabis,” Englund said. “But the problem we see in research is all the hype that's being built around cannabis… with that comes a potential for a very strong placebo effect.”
“And that's one of the key sticking points when it comes to a field like medicinal cannabis research: a lot of studies don't have a placebo comparison, or [are] based on people who go to dispensaries and use for their own medical conditions and their own self-reports of cannabis.”
The first prescriptions destined for the Project Twenty21 have already arrived in Europe, with the project been exclusively supplied by the Latin American firm Khiron Life Sciences. These products will be first issued to UK doctors, who can then prescribe them to the patients enrolled in the experiment.
