Randomised controlled trials have a long history of being used widely in medical research. However, depending entirely on this kind of test when researching cannabis-based medicines has led to strict rules that keep patients from obtaining potentially life-saving therapies. The current evidence based on randomised controlled trials for cannabis medical products is not enough because they are not appropriate to the complex nature of whole plant medicines.
Randomised controlled trials are types of studies where participants randomly receive different treatments. This method evaluates the effectiveness and safety of medical products. It compares outcomes between the treatment group and the control group.
What is real-world evidence and how can it help the medical cannabis sector?
Real-world evidence refers to methods where data is taken from real-world cases. This can include routine clinical practice, registries, or health records. It provides insights from everyday clinical practice outside the controlled environment of randomised controlled trials. The use of real-world evidence with patient-reported outcomes seems to be a game-changer. It expanded the evidence base and shed light on the positive impact of medical cannabis on patients’ lives.
When it comes to the study of cannabis-based therapeutic products, real-world data has many benefits. First off, it makes it possible to include larger and more diverse patient populations. By being inclusive, the research will accurately reflect the diversity of the patient community, which includes people with a range of comorbidities, age groups, genders, and socioeconomic statuses.
The case of prescribed cannabis in the United Kingdom shows the value of real-world evidence. Technically, the laws in the UK allow the prescription of cannabis-based medicines. However, a lack of access through the NHS requires qualified patients to deal with the commercial sector and its costs. An empirical registry called Project Twenty21 was set up to collect solid data on the use and possible efficacy of medicinal cannabis. This innovative registry, which just increased its reach to Australia, gathers thorough data on the usage of medicinal cannabis in the UK.
For instance, the data gathered by Project Twenty21 shows that patients frequently use various cannabis products at the same time, often with large dose fluctuations. This emphasises the significance of keeping an eye on every outcome, including patient-reported, safety, and efficacy data. In addition, real-world evidence provides insight into the simultaneous use of other pharmaceuticals next to cannabis. Additionally, it enables research of patients who also have coexisting medical or psychological issues.
What is in it for scientists and policymakers?
Several suggestions can be made in order maximise the potential of real-world evidence in the case of medical cannabis. First, policymakers and prescribers need to adopt an extensive approach. Furthermore, it is critical to create large observational registries, similar to Project Twenty21. These registries should systematically gather information about the use of medical cannabis among various patient categories and diseases.
Collaboration between scientists, medical professionals, patients, and decision-makers is crucial. Collaboration can improve both the reliability and relevance of real-world evidence research. To ensure consistency and comparability among various real-world evidence studies, standard methods for data collecting and analysis should also be established. This will make it possible to combine and analyse the data in more effective ways. In real-world studies, errors and factors that confound may exist, therefore efforts should be taken to overcome these issues.
Healthcare professionals need to get education about the importance of real-world evidence as well as how to evaluate and apply it in practice in order to facilitate the integration of real-world evidence into clinical decision-making. Programs and guidelines for continuing medical education can be quite effective in promoting evidence-based and patient-focused care.
Last but not least, decision-makers must recognize the significance of empirical data in creating medical cannabis healthcare regulations. When creating guidelines, laws, and reimbursement policies, they should actively take the conclusions and revelations gained through in-depth research into consideration.
Real-world evidence can therefore be a useful tool for researching the medical benefits of cannabis. It can also help to increase the scope of evidence beyond conventional randomised control trials. We may get an in-depth understanding of the safety, effectiveness, and practical effects of cannabis by adopting patient-reported outcomes and real-world evidence.