What are clinical trials?
Clinical trials are research studies that test a medical, surgical, or behavioural intervention in people with a certain medical condition. These trials help researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in the tested group of individuals. Clinical trials can also show if a new treatment is more effective or has less harmful side effects than existing treatments.
Key objectives of clinical trials also include:
- Developing early disease diagnosis methods, potentially before symptoms appear
- Identifying prevention strategies for those at high risk of certain diseases
- Improving the quality of life for individuals with chronic or life-threatening health conditions
Why are clinical trials crucial in advancing medical treatment?
Clinical trials are crucial in advancing medical treatment as they are the gold-standard method for testing new treatments. Clinical trials evaluate treatments in controlled environments and provide the data healthcare professionals need to make informed decisions.
The goal of a clinical trial is to look at two or more groups which have similar characteristics, through using randomisation. By doing this, researchers can be more confident that the differences between different medications, for example, are because of the treatment, rather than an external factor.
In the UK, clinical trials play a role in determining which new medicinal products can receive licensing approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
Clinical trials are essential for the progression of medical science and the enhancement of patient outcomes globally.
How are clinical trials funded in the UK?
Clinical trials are expensive to run as there are many operational costs involved, for example, the treatments, procedures, research staff and administrative costs.
In the UK, clinical trials can be funded by:
- The Government, via organisations such as the Medical Research Council and National Institute for Health Research
- Pharmaceutical companies
Why is there a lack of clinical trials on medical cannabis?
The rescheduling of medical cannabis, whilst important, does not remove all barriers to patient access as national guidance from the National Institute for Health and Care Excellence (NICE) does not recommend its use outside of a few specific circumstances.
The lack of funding towards medical cannabis trials has been a major stumbling block in advancing scientific understanding of medical cannabis. The National Institute for Health Research has not funded any studies of medical cannabis since its rescheduling.
Some of the barriers to conducting medical cannabis clinical trials are:
- Complexity of the Plant
- Medical cannabis is not just one drug. Each flower contains a broad spectrum of compounds. The most common of these are cannabidiol (CBD) and tetrahydrocannabinol (THC), but there are more than 600 compounds that can be found within cannabis flower.
- As cannabis is a natural product, the underlying genetics of the plant and the conditions it is grown in can vastly affect the chemical composition of the flower. This means that the effects seen in one clinical trial using one medical cannabis product, may not be directly translatable to another trial studying the same condition, but using a different form of medical cannabis.
- For clinical trials to arrive at a result that is not biased by already held beliefs about the effectiveness of a given treatment, participants and the doctors prescribing each medication need to be unaware of the medication they are taking. In clinical trials we call this blinding. Due to the associated aroma, administration methods, and physical and mental effects of cannabis being so different to already used treatments for many conditions this makes it hard to effectively blind participants and researchers as to which medication they have been prescribed.
Doctors in the UK follow NICE guidelines and prescribing protocols when prescribing within the NHS. However, NICE has advised doctors against prescribing medical cannabis primarily due to the lack of high-quality clinical trials that demonstrate its cost-effectiveness. As such access to medical cannabis is limited to specialist private clinics.
Why do we need clinical trials for medical cannabis?
Clinical trials are essential for providing the data needed to evaluate the efficacy and safety of medical treatments. Medical cannabis clinical trials could provide the evidence needed to determine its therapeutic benefits, understand its side effects, and determine appropriate dosages.
Clinical trials could pave the way for medical cannabis to be considered a viable and regular prescription option, integrated into mainstream healthcare just like any other medication, and thereby enhancing patient access and care.
Recent developments on medical cannabis trials
In August 2023, it was announced that NHS Scotland is financing a clinical trial to study the impact of CBD on pelvic pain in women with endometriosis. The trial will involve 100 women and aims to provide evidence for a potential UK-wide study on cannabinoids for endometriosis pain and could lead to NHS-supported treatment options.
What are Curaleaf Clinic doing to advance medical cannabis research?
Curaleaf Clinic are dedicated to ensuring that they play a defining role in helping clinicians and patients make the right decisions for their healthcare. As part of this commitment, we have developed the UK Medical Cannabis Registry to help analyse the outcomes of patients seen at the clinic to help inform the care of patients. At Curaleaf we use this data to help inform how we work to optimise the care we provide individual patients.
By publishing our findings, we also aim to help drive forward medical cannabis science in the UK and abroad. This is integral in helping remove the barriers to access that currently exist for patients. This data also highlights the outcomes in different medical conditions and across different medications, helping to guide the clinical trials in the future.
What is the UK Medical Cannabis Registry?
The UK Medical Cannabis Registry is the largest real world data platform for medical cannabis outcomes in the UK, providing insight into clinical outcomes and monitoring safety of medical cannabis, with a focus on health-related quality of life (HRQoL).
To date, the UK Medical Cannabis Registry has evaluated the outcomes of medical cannabis in patients with chronic pain, generalised anxiety disorder, autism spectrum disorder, post-traumatic stress disorders, depression, headache disorders, and paediatric epilepsy.
In our study ‘UK Medical Cannabis Registry: A Patient Evaluation’ we found that 92.2% of patients agreed that contributing to the registry would impact the medical care of future patients.
To learn more about the UK Medical Cannabis Registry click here.
To learn more about our study ‘UK Medical Cannabis Registry: A Patient Evaluation’ click here.