A new paper makes the case for real world evidence to be considered by regulators in order to overcome ‘harmful’ restrictions to medical cannabis access.
In a new peer-reviewed paper, published today (Thursday 3 November), researchers at Drug Science have outlined a number of key recommendations aimed to help policymakers see the value of real world evidence (RWE) in medical cannabis research.
They have urged them to consider the existing global database when developing approaches to overcome the current barriers to access.
The ‘gold standard’
Randomised control trials (RCTs) have traditionally been viewed as the ‘gold standard’ of scientific evidence, something which regulators and medical bodies have continually called for before cannabis medicines can be rolled out on the NHS.
The lack of RCTs on cannabis has so far resulted in restrictive guidelines around the prescribing of the treatment.
However, as experts have previously highlighted and have stated in the report, RCTs do not ‘lend themselves well’ to whole-plant medicines such as cannabis, due to the complexity of the plant and the many different compounds which make up the entourage effect.
Meanwhile there is a huge database of real world evidence from across the globe for the efficacy of cannabis in a number of health conditions, including in the UK through Project Twenty21 and Sapphire Access Scheme.
In their paper, which explores the benefits of real world evidence in cannabis medicine, researchers publicly challenge the view that RCTs are the only form of valid scientific evidence.
The benefits of real world evidence
Real world evidence, collected through observational studies, allows researchers to capture the experiences of patients living with comorbidities or multiple diagnoses, who would be excluded from RCTs.
Previous research from Drug Science has shown that the majority of medical cannabis patients are living with up to 10 comorbidities alongside their primary diagnosis.
They are also more cost-effective to run and allow researchers to collect data on larger sample sizes, over longer periods of time, to get a true picture of the patient experience.
Lead author of the study, Dr Anne Katrin Schlag, commented: “RCTs are widely considered the ‘gold standard’ in relation to medicine, whilst RWE approaches have been regarded as less reliable, and less strong evidence.
“However, as we highlight in our paper, in relation to medical cannabis, the current RWE database is huge, including for example, 1,000s of patients from Health Canada, Minnesota, BFarm in Germany, and here in the UK, Project Twenty21. These large numbers have been building up to a pattern of evidence, indicating for which conditions and which patients medical cannabis might work.
“By outlining the value of RWE in relation to medical cannabis, we hope our paper can improve on the perspective that only RCTs are valid as scientific evidence.”
The 12 key recommendations outlined by Dr Schlag and her colleagues, also touch on some of the historical issues with RCTs.
For instance, participant samples in these trials are often not representative of the general population, leading to ‘ethnic and racial disparities’ in healthcare.
They also highlight 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’.
As Dr Schlag said: “Doctors should listen to patients- as in some cases, such as in relation to rare diseases, patients and their families are becoming the experts in their/their loved ones’ treatment.”
Overcoming ‘harmful’ restrictions
Some recent developments suggest that understanding of the value in RWE is improving among the medical and scientific communities.
The European Medicines Agency (EMA) has launched a Data Analysis and Real World Interrogation Network to deliver real world evidence on diseases, populations and the uses and performance of medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) has also published new guidelines outlining how greater use of real-world data for clinical trials could help patients access new medicines sooner. However, the body has yet to accept real-world and observational data on its own.
While RCTs still have an important role to play and are helpful for collecting safety data and monitoring potential adverse effects, the authors say that the RWE needs to be considered in order to overcome the current ‘harmful’ restrictions to access.
They conclude: “We hope that this paper will aid policymakers and prescribers understand the value of RWE in relation to medical cannabis and help them develop approaches to overcome the current situation, which is ultimately harmful to patients, restricting access to medicines that could bring relief.”
Dr Schlag added: “Cannabis has been used for millennia, and has an excellent safety profile with very few serious adverse events. Huge numbers of patients are using medical cannabis to successfully treat a broad variety of conditions and we need to take their experiences into account, rather than dismissing them.
“This is important for patient access, which at the moment, is still largely limited to the private healthcare space.”
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