Clinical trials with cannabis medicines-guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Jennifer H Martin¹, Courtney Hill², Anna Walsh³, Daryl Efron^{4

5

6}, Kaitlyn Taylor⁴, Michael Kennedy⁷, Rachel Galettis², Paul Lightfoot⁸, Julie Hanson⁹, Helen Irving¹⁰, Meera Agar¹¹, Judith Lacey^{12

13

14}

Affiliations

¹ Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Division of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia. jen.martin@newcastle.edu.au.
² Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Division of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
⁴ Murdoch Children's Research Institute, Parkville, Victoria, Australia.
⁵ The Royal Children's Hospital, Parkville, Victoria, Australia.
⁶ Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
⁷ St Vincent's Clinical School, UNSW Medicine, UNSW Sydney and Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
⁸ Department of Neurology, Austin Health, Heidelberg, Victoria, Australia.
⁹ School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Maroochydore, Queensland, Australia.
¹⁰ Children's Health Queensland, Hospital and Health Service, University of Queensland, Brisbane, Queensland, Australia.
¹¹ IMPACCT, University of Technology Sydney, Sydney, New South Wales, Australia.
¹² Chris O'Brien Lifehouse Comprehensive Cancer Hospital, Camperdown, New South Wales, Australia.
¹³ School of Medicine, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ NICM Health and Research Institute, Western Sydney University, Penrith, New South Wales, Australia.

PMID: 33203469
PMCID: PMC7673085
DOI: 10.1186/s13063-020-04862-6

Clinical trials with cannabis medicines-guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Jennifer H Martin et al. Trials. 2020.

. 2020 Nov 17;21(1):932.

doi: 10.1186/s13063-020-04862-6.

Authors

Affiliations

¹ Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Division of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia. jen.martin@newcastle.edu.au.
² Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Division of Clinical Pharmacology, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.
³ NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
⁴ Murdoch Children's Research Institute, Parkville, Victoria, Australia.
⁵ The Royal Children's Hospital, Parkville, Victoria, Australia.
⁶ Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
⁷ St Vincent's Clinical School, UNSW Medicine, UNSW Sydney and Department of Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia.
⁸ Department of Neurology, Austin Health, Heidelberg, Victoria, Australia.
⁹ School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Maroochydore, Queensland, Australia.
¹⁰ Children's Health Queensland, Hospital and Health Service, University of Queensland, Brisbane, Queensland, Australia.
¹¹ IMPACCT, University of Technology Sydney, Sydney, New South Wales, Australia.
¹² Chris O'Brien Lifehouse Comprehensive Cancer Hospital, Camperdown, New South Wales, Australia.
¹³ School of Medicine, University of Sydney, Sydney, New South Wales, Australia.
¹⁴ NICM Health and Research Institute, Western Sydney University, Penrith, New South Wales, Australia.

PMID: 33203469
PMCID: PMC7673085
DOI: 10.1186/s13063-020-04862-6

Abstract

With cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as a therapeutic option in the treatment and management of a range of indications is being noted. Despite this accessibility, knowledge on optimal use is lacking. Further drug development and clinical trials at regulatory standards are necessary both if a better understanding of the efficacy of cannabis medicines, optimal product formulation and indication-specific dosing is needed and to ensure the broader quality and safety of cannabis medicines in the clinical setting.To enable this, clinical, academic and public calls for the undertaking of rigorous clinical trials to establish an evidence base for the therapeutic use of cannabis medicines have been made internationally. While this commitment to undertake human studies with cannabis medicines is welcomed, it has highlighted unique challenges, notably in the review stages of ethics and governance. This often results in lengthy delays to approval by Human Research Ethics Committees (herein 'HREC', Australia's nomenclature for Institutional Review Boards) and trial commencement. A principal concern in these cases is that in contrast to clinical trials using other more conventional pharmaceutical products, trials of cannabis medicines in humans often involve the use of an investigational product prior to some (or any) of the preclinical and pharmaceutical safety issues being established. This paucity of data around product safety, potential drug interactions, continuity of supply, shelf life and product storage results in apprehension by HRECs and governance bodies to endorse trials using cannabis medicines.This manuscript draws from the experiences of Australian researchers and staff involved in clinical trials of cannabis medicines to describe some of the common difficulties that may be faced in the HREC approval process. It also presents practical advice aimed to assist researchers, HRECs and governance officers navigate this complex terrain. While the authors' experiences are situated within the Australian setting, many of the barriers described are applicable within the international context and thus, the solutions that have been proposed are typically adaptive for use within other jurisdictions.

Keywords: Cannabinoids; Cannabis medicines; Cannabis medicines research; Clinical trials; Governance; Human research ethics; Investigational medicinal product.

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Conflict of interest statement

JH, AW, PL, KT, MK and HI declare no competing interests.

Professor Meera Agar is chair of the Medical Research Ethics Committee at the University of Technology Sydney, a member of South West Sydney Human Research Ethics Committee. Professor Agar also receives NSW Government funding for clinical trials ‘Evaluation of pharmaceutical cannabinoids and standardized botanical leaf cannabis for anorexia in advanced cancer’.

Professor Jennifer Martin, Dr Rachel Galettis and Courtney Hill are part of the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), which is funded through the National Health and Medical Research Council’s Centres of Research Excellence Program. ACRE also receives funding through NSW Health’s Clinical Cannabis Medicines Program, which supports Dr Galettis and Ms Hill’s roles as Clinical Trial Manager and Clinical Trial Coordinator for the CARE NSW Trial.

A/Prof Judith Lacey is an investigator on a “Phase 2 Randomised, Double-Blind Clinical Trial Assessing the Tolerability Of Two Different Ratios Of Cannabis medicines In Patients With Glioblastoma Multiforme (GBM)”. Supported by Bioceuticals pharmaceuticals.

References

1. Therapeutic Goods Administration . Access to medicinal cannabis products [Internet] 2020.
1. National Health & Medical Research Council . National Statement on Ethical Conduct. 2007.
1. Therapeutic Goods Administration . Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017. 2019.
1. Therapeutic Goods Administration . Good manufacturing practice - an overview [Internet] 2017.
1. Therapeutic Goods Administration. Clinical Trials [updated 25 March 2020. Available from: https://www.tga.gov.au/clinical-trials.

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Clinical trials with cannabis medicines-guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Affiliations

Clinical trials with cannabis medicines-guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources