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

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 e...

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Autores principales: Schlag, Anne Katrin, Zafar, Rayyan R., Lynskey, Michael T., Athanasiou-Fragkouli, Alkyoni, Phillips, Lawrence D., Nutt, David J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9669276/
https://www.ncbi.nlm.nih.gov/pubmed/36405915
http://dx.doi.org/10.3389/fpsyt.2022.1027159
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author Schlag, Anne Katrin
Zafar, Rayyan R.
Lynskey, Michael T.
Athanasiou-Fragkouli, Alkyoni
Phillips, Lawrence D.
Nutt, David J.
author_facet Schlag, Anne Katrin
Zafar, Rayyan R.
Lynskey, Michael T.
Athanasiou-Fragkouli, Alkyoni
Phillips, Lawrence D.
Nutt, David J.
author_sort Schlag, Anne Katrin
collection PubMed
description 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.
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spelling pubmed-96692762022-11-18 The value of real world evidence: The case of medical cannabis Schlag, Anne Katrin Zafar, Rayyan R. Lynskey, Michael T. Athanasiou-Fragkouli, Alkyoni Phillips, Lawrence D. Nutt, David J. Front Psychiatry Psychiatry 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. Frontiers Media S.A. 2022-11-03 /pmc/articles/PMC9669276/ /pubmed/36405915 http://dx.doi.org/10.3389/fpsyt.2022.1027159 Text en Copyright © 2022 Schlag, Zafar, Lynskey, Athanasiou-Fragkouli, Phillips and Nutt. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Psychiatry
Schlag, Anne Katrin
Zafar, Rayyan R.
Lynskey, Michael T.
Athanasiou-Fragkouli, Alkyoni
Phillips, Lawrence D.
Nutt, David J.
The value of real world evidence: The case of medical cannabis
title The value of real world evidence: The case of medical cannabis
title_full The value of real world evidence: The case of medical cannabis
title_fullStr The value of real world evidence: The case of medical cannabis
title_full_unstemmed The value of real world evidence: The case of medical cannabis
title_short The value of real world evidence: The case of medical cannabis
title_sort value of real world evidence: the case of medical cannabis
topic Psychiatry
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9669276/
https://www.ncbi.nlm.nih.gov/pubmed/36405915
http://dx.doi.org/10.3389/fpsyt.2022.1027159
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