A Clinical Practice Guideline for the Use of Medical Cannabis and Cannabinoids for Chronic Pain

What Kind of Medical Cannabis Research Should be Prioritised? A Patient Perspective

In November 2018, the UK government officially rescheduled cannabis, allowing for its medicinal utilisation under specific circumstances. The law change was in line with various other legislative changes taking place around the world, including in Europe, the Americas, and Australasia. Four years on from the introduction of this legislation, however, there remains a paucity of high-quality clinical evidence to demonstrate the safety and efficacy of cannabis-based medical products. 

This scarcity is partly due to the regulatory barriers that resulted from cannabis’ classification as a Schedule 1 drug – which by definition means it has no medicinal value. As a result, primary research into cannabis was strictly limited for decades. Since the rescheduling of cannabis, researchers have been more at liberty to assess the potential of cannabis for various conditions and illnesses – but there is still a long way to go. There is still limited funding for medical cannabis research; furthermore, biomedical research is often found to be wasteful due to inefficiencies – one of the major contributing factors being the selection of research questions which fail to match the priorities of patients or clinicians.

There is, therefore, a growing desire to involve patients and clinicians in the research and design process. It is hoped that this will help to increase the clinical relevancy of medical cannabis research in the future. To this aim, the authors of a recent study sought to “ascertain which themes were important to medical cannabis patients in the UK to help inform a locoregional research agenda.”

Design and Methods of the Study

The researchers conducted a qualitative focus group study involving participants who were undergoing active medical cannabis treatment in the UK. Participants were recruited from Sapphire Medical Clinics, the first regulated medical cannabis clinic to treat patients across the whole of the UK. Participants were required to be current medical cannabis patients, having at least one prescription documented in their health records within the previous three months as verified by the research team.

The Focus Group

The focus groups were conducted virtually on Microsoft Teams. Each discussion lasted approximately 2 hours and was convened by the same author who had previous experience running focus groups. The first part of the discussion was designed to facilitate a conversation around patient priorities concerning medical cannabis research with the open question: “What are the most important research priorities to you?” If this question was not naturally answered during the discussion, the facilitator also prompted participants to consider the biochemistry of the plant, medical applications, research design, pharmacology, and socioeconomic impact of medical cannabis.

For the second part of the focus group, participants were asked to complete a financial allocation task which involved allocating funds (represented by counters) to specific areas of medical cannabis research. Participants were provided with a list of potential research priorities. They were allocated 10 counters – each of which represented £1 million. Participants were allowed to allocate more than one counter to each priority. This part of the study was designed to replicate the challenge of multiple demands as well as to identify the priorities that were most important to the participants. In addition to the list of pre-selected potential priorities, participants were also encouraged to add other priorities.

Finally, the participants were asked to present their decisions to the group, along with their reasoning. Following this response period, participants were allowed to reallocate their counters before final recording.

Results of the Study

Priority Themes

Three focus groups were conducted, including a total of 10 participating patients. Overall, nine themes and 39 sub-themes were identified across three domains: Clinical, Barriers, and Development. The ‘Clinical’ domain included ‘Adverse Events’, ‘Comparison Between Cannabis-Based Products’, ‘Health Conditions’, and ‘Pharmacology of Cannabis’; the ‘Barriers’ domain included ‘Health Care Professionals Attitudes’, and ‘Social Environment’; and the ‘Development’ domain included ‘Agriculture and Manufacturing’, ‘Cannabis Plant’, and ‘Types of Study’.

Clinically, there was a directive towards ensuring that research is either condition- or symptom-specific. Furthermore, the conditions that were deemed to be the highest priorities among participants were chronic pain, anxiety, and post-traumatic stress disorder. Participants also highlighted the importance of researching the social impacts of medical cannabis, including knowledge of medical cannabis among healthcare workers, stigma, and implications on employment and driving.

Simulated Allocation of Funding

A total of 26 counters (8.7%) were allocated to ‘assessment of effects on specific symptoms’ – the highest proportion of funds allocated to any sub-domain. The clinical effects of cannabis on specific conditions and health-related quality of life were also considered particularly important among the participants. This finding is in line with prior analysis in other domains which also identified clinical research as an important priority. 

Despite this finding, an analysis of cannabis research funding in the UK, USA, and Canada found that the highest proportion of funding was provided towards assessing the adverse effects of cannabis and its potential for misuse. Analysis of adverse events was identified as a priority during thematic analysis, however, it received only 1.3% in the simulated funding allocation, compared to 19.7% for condition-specific research, 8.7% according to specific symptoms, or even 6.7% towards assessment of health-related quality of life. The participants also equally acknowledged the importance of randomised controlled trials and real-world evidence.

Other Findings

The participants also highlighted themes related to the social impact of medical cannabis, such as knowledge of cannabis among healthcare professionals and stigma. There was also an interest in manufacturing and the development of medical cannabis products.

Conclusions

This study identified several themes for prioritisation in future medical cannabis research – in particular from the point of view of active medical cannabis patients in the UK. As the first study of its kind to focus on this issue, the results demonstrate a directive towards ensuring that research is either symptom- or condition-specific. The authors of this study note that, due to the patient sample used, the results of this study are likely to only be transferrable to patients from the UK and may not accurately reflect the priorities of patients in other jurisdictions. Nonetheless, these results offer valuable insight to help “guide both research funders and researchers alike into effectively implementing research which fits within a more patient-centric model.”