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Review
. 2022 Nov 3:13:1027159.
doi: 10.3389/fpsyt.2022.1027159. eCollection 2022.

The value of real world evidence: The case of medical cannabis

Anne Katrin Schlag  1   2 , Rayyan R Zafar  1   2 , Michael T Lynskey  1 , Alkyoni Athanasiou-Fragkouli  1 , Lawrence D Phillips  1   3 , David J Nutt  1   2
Affiliations
Review

The value of real world evidence: The case of medical cannabis

Anne Katrin Schlag et al. Front Psychiatry. .

Abstract

Randomised controlled trials (RCTs) have long been considered the gold standard of medical evidence. In relation to cannabis based medicinal products (CBMPs), this focus on RCTs has led to very restrictive guidelines in the UK, which are limiting patient access. There is general agreement that RCT evidence in relation to CBPMs is insufficient at present. As well as commercial reasons, a major problem is that RCTs do not lend themselves well to the study of whole plant medicines. One solution to this challenge is the use of real world evidence (RWE) with patient reported outcomes (PROs) to widen the evidence base. Such data increasingly highlights the positive impact medical cannabis can have on patients' lives. This paper outlines the value of this approach which involves the study of interventions and patients longitudinally under medical care. In relation to CBMPs, RWE has a broad range of advantages. These include the study of larger groups of patients, the use of a broader range and ratio of components of CBMPs, and the inclusion of more and rarer medical conditions. Importantly, and in contrast to RCTs, patients with significant comorbidities-and from a wider demographic profile-can also be studied, so providing higher ecological validity and increasing patient numbers, whilst offering significant cost savings. We conclude by outlining 12 key recommendations of the value of RWE in relation to medical cannabis. We hope that this paper will help policymakers and prescribers understand the importance of RWE in relation to medical cannabis and help them develop approaches to overcome the current situation which is detrimental to patients.

Keywords: cannabis based medicinal products (CBMPs); medical cannabis; patient access; patient reported outcomes (PROs); real world evidence (RWE).

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Conflict of interest statement

Author DN was Chair of the charity Drug Science. Author ML was Chief Research Officer of Drug Science. Author AS was Head of Research of Drug Science and scientific advisor to the Primary Care Cannabis Network, and an executive member of the Cannabis Industry Council, both unpaid roles. Author AA-F was study co-ordinator of Project Twenty21. Author RZ was Researcher at Drug Science. Author LP was expert member of the Drug Science Medical Cannabis Working Group. Drug Science receives an unrestricted educational grant from a consortium of medical cannabis companies to further its mission, that is the pursuit of an unbiased and scientific assessment of drugs regardless of their regulatory class. All Drug Science committee members, including the Chair, are unpaid by Drug Science for their effort and commitment to this organization. None of the authors would benefit from the wider prescription of medical cannabis in any form.

Figures

FIGURE 1
FIGURE 1
Monthly seizure frequency pre- and post- cannabis based medicinal products (CBMPs).
See this image and copyright information in PMC

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