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Pharmacoepidemiology and Drug Safety
Article . 2020 . Peer-reviewed
License: Wiley Online Library User Agreement
Data sources: Crossref
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Translational hurdles with cannabis medicines

Authors: Myfanwy Graham; Catherine J. Lucas; Jennifer Schneider; Jennifer H. Martin; Wayne Hall;

Translational hurdles with cannabis medicines

Abstract

AbstractPurposeInternationally, there has been widespread medical use of cannabis medicines before rigorous evaluations in randomised controlled trials (RCTs). Some advocates of medicinal use of cannabis argue that real‐world evidence (RWE) can be a substitute for or at least supplement evidence from RCTs. We explore the utility, limitations and impact of RWE in the translation of cannabis medicines research into clinical practice using the established literature.MethodsA literature search was performed via Embase and Medline using a diverse range of cannabinoid and RWE search terms. The review provides a snapshot of cannabis medicine RWE initiatives from around the world.ResultsDiverse and novel sources of real‐world data and RWE include international cannabis registries, surveys, post‐marketing data collection and use of electronic or digital health records. The strengths and limitations of using RWE in translational research are highlighted, along with the identification of barriers to RCTs involving cannabis medicines.ConclusionsRWE promises to play a significant role in the evaluation of cannabis medicines around the world. When used appropriately RWE may complement RCT data by providing valuable insights into cannabis medicine safety and effectiveness.Take Home Messages It is important that real‐world evidence (RWE) is used to complement rather than replace randomised controlled trial (RCT) evidence on cannabis medicines. Technological advances have created the opportunity to explore diverse and novel sources of cannabis medicine RWE. Although RWE may be more reflective of real‐world clinical practice, it cannot provide conclusive evidence of the safety and efficacy of cannabis medicines. While acknowledging its limitations, RWE may nonetheless provide some guidance on safety and adverse events of cannabis medicines. RWE has already had a significant impact on the regulation of cannabis medicines.

Country
Australia
Keywords

Evidence-Based Medicine, Medical Cannabis, 302, Thccbd, Medical Marijuana, Treatment Outcome, Health, Surveys and Questionnaires, Product Surveillance, Postmarketing, 2736 Pharmacology (medical), Electronic Health Records, Humans, Registries, Safety, Chronic Pain, Drug Approval, 2713 Epidemiology, Randomized Controlled Trials as Topic

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    popularity
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    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
21
Top 10%
Top 10%
Top 10%
bronze