UK medical cannabis clinic, Releaf, is investing in an ambitious new research programme to collect critical real-world evidence on the effects of medical cannabis treatments. Could it help bridge the knowledge gaps and bring regulators on board?
Regulators and medical professionals have repeatedly called for more ‘high quality evidence’ to support the safety and efficacy of cannabis-based medicines, before they can be prescribed more widely. Yet since medical cannabis was legalised in 2018, government funding to carry out this much-needed research has been lacking.
Things seemed hopeful when the NHS established its patient registry to collect data on the prescribing of cannabis-based medicines in 2021. However, two years later in 2023 Cannabis Health revealed that it had not enrolled any patients and is still not thought to be widely used by clinicians.
Meanwhile, the first two NHS-funded clinical trials investigating CBD and THC in epilepsy are only expected to begin recruiting this year — six years after they were initially recommended in a 2019 review by the former Health Secretary, Matt Hancock. Campaigners have previously described this lack of NHS data as ‘disappointing’ and ‘infuriating’.
A ‘crucial contribution’ to real-world evidence
While NHS progress remains stagnant, private cannabis clinics such as Releaf, are seeing growing numbers of patients report positive effects of cannabis-based treatments for a wide range of conditions.
To utilise this data and help build the crucial evidence base to advance cannabis-based medicine, Releaf has invested in its own research programme to track patient-reported outcomes across a broad range of conditions.
“The purpose of this data collection is to demonstrate the effectiveness of medicinal cannabis therapy for treating the symptoms of a range of different conditions that we see in our clinic,” explains Dr Hanna Gul, Research and Quality Director at Releaf, who is leading the programme.
“This data is a crucial contribution to real-world evidence that is needed to help inform prescribing guidance and influence policy changes in this field – making it more accessible— and it can also help us provide more targeted/individualised treatment plans for our patients.”
Releaf is currently providing medicinal cannabis treatment across a range of medical specialties. As part of the programme, all patients will complete a general health-related quality of life assessment (EQ5-D), as well as disease-specific questionnaires at their first appointment, and then at one, three, six, nine and 12 months.
In total, the programme will be implementing 15 validated tools for the following conditions, with scope to expand these in the future:
- Parkinson’s Disease
- Epilepsy
- Multiple Sclerosis
- Migraine
- Rheumatoid Arthritis
- Osteoarthritis
- Menopause
- Ankylosing Spondylitis
- Depression
- Anxiety
- Chronic Pain
- Fibromyalgia
- Restless Legs syndrome
- Insomnia
The data will then be analysed with a view to publication in peer-reviewed medical journals, in order to contribute to the existing body of real-world evidence for the efficacy of cannabis-based medicines.
Dr Hanna Gul, Research and Quality Director at Releaf
Placing greater value on real-world evidence
While clinical trials are widely thought of as the ‘gold standard’ in science, real-world evidence can provide broader insights which are more reflective of patient experiences. They can also serve as a helpful starting point to inform future randomised control trials (RCTs).
“Real-world evidence is more representative of the general population compared to clinical trial data, which often places restrictions on who can/cannot participate in a trial due to strict inclusion/exclusion criteria,” Dr Gul explains.
Campaigners, clinicians and scientists have repeatedly called for regulators to consider the real-world evidence for medical cannabis. RCTs are designed for single-compound pharmaceuticals, making them challenging to conduct on cannabis products, which contain hundreds of different compounds.
In a peer-reviewed paper from 2022, researchers from Drug Science publicly challenged the view that RCTs are the only form of valid scientific evidence, urging policymakers to consider the existing real-world data.
The authors outlined several key recommendations aimed to help policymakers see the value of this evidence in medical cannabis research. This included highlighting the importance of doctors listening to the views and experiences of patients, stating that doctors should ‘develop the evidence base together with their patients to better define indications’.
Regulators response to real-world evidence
Regulatory bodies have also acknowledged the need to place more value on real-world evidence alongside RCTs.
In 2021, the MHRA published new guidance for researchers hoping to use real-world data sources in clinical studies to support regulatory decisions.
Speaking at the time, former MHRA CEO, Dr June Raine, said: “When used in this innovative way, real-world data has the potential to make a huge difference when it comes to bringing medicines through clinical trials to patients.”
The following year, NICE published its real-world evidence framework, and highlighted within its strategy for 2021-2026 how it planned to use real-world data to ‘resolve gaps in knowledge and drive forward access to innovations for patients’.
Looking further afield, the European Medicines Agency (EMA) has also launched a Data Analysis and Real World Interrogation Network to deliver real-world evidence on diseases, populations and the uses and performance of medicines.
Collecting data on less-reported conditions
This is not the first time real-world evidence has been collected on medical cannabis in the UK. Numerous papers have been published based on patient-reported outcomes over the last six years, most notably through Drug Science’s T21 patient registry.
Dr Gul notes that while these have focused on conditions such as chronic pain, depression and anxiety, through the general quality of life questionnaires, Releaf plans to cover a wider variety of indications, and will likely exceed patient numbers captured in other studies.
“Patient-reported outcomes have been reported by other clinics, but they have not been used to the extent that we plan to or cover such a wide variety of conditions,” she adds.
“We aim to provide data on less-reported conditions in this field to support increased patient access to CBPM treatment, in addition to adding to the evidence base for conditions that have already been studied.
The post Closing the Gap: How Real-World Evidence Could Reshape UK Medical Cannabis Policy appeared first on Cannabis Health News.
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