接受姑息治疗患者的医用大麻临床试验的设计考量

Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care.

作者信息

Razmovski-Naumovski Valentina, Martin Jennifer H, Chye Richard, Phillips Jane L, Lintzeris Nicholas, Solowij Nadia, Lee Jessica, Lovell Melanie, Noble Bev, Galettis Peter, Brown Linda, Fazekas Belinda, Clark Katherine, Luckett Tim, McCaffrey Nikki, Currow David C, Agar Meera R

机构信息

South West Sydney Clinical Campuses (VRN, MRA), Faculty of Medicine and Health, University of New South Wales Sydney, Sydney, New South Wales, Australia; Improving Palliative (VRN, RC, JLP, LB, BF, TL, DCC, MRA), Aged and Chronic Care through Clinical Research and Translation (IMPACCT), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Ingham Institute of Applied Medical Research (VRN, MRA), Sydney, New South Wales, Australia.

Discipline of Clinical Pharmacology (JHM, PG), School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia; The Australian Centre for Cannabinoid Clinical and Research Excellence (JHM, NL, NS, PG), New Lambton Heights, Newcastle, New South Wales, Australia.

出版信息

J Pain Symptom Manage. 2025 May;69(5):e395-e408. doi: 10.1016/j.jpainsymman.2025.02.009. Epub 2025 Feb 21.

DOI:10.1016/j.jpainsymman.2025.02.009

PMID:39988015

Abstract

CONTEXT

Evaluating medicinal cannabis in clinical trials is important for informing its efficacy and safety in clinical care. Alongside the inherent practical challenges of conducting clinical trials in people receiving palliative care, operationalizing clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements.

OBJECTIVES

This manuscript aims to explore these considerations when operationalizing medicinal cannabis clinical trials in people receiving palliative care.

METHODS

Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporized medicinal cannabis product for anorexia in people with advanced cancer (ACTRN12616000516482). Using action research methodology, notes from trial investigator meetings served as an audit trail for the planning and execution of the trial. These data were integrated and synthesized to reveal key design considerations for operationalizing medicinal cannabis trials evaluating symptom control in people receiving palliative care.

RESULTS

Six key considerations emerged including: 1) Operating within medicinal cannabis legislation; 2) Biological plausibility of cannabinoid type(s) and impact on target symptoms; 3) Standardising cannabinoid content, mode of administration, dosage and packaging; 4) Ethical and safety considerations; 5) Optimizing trial site operationalization; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed.

CONCLUSION

This study explores the learnings and challenges involved in designing and conducting medicinal cannabis trials for symptom management in people receiving palliative care. These insights gained from our experience can inform the optimal design and operationalization of future medicinal cannabis trials in cancer and other chronic conditions.

摘要

背景

在临床试验中评估药用大麻对于了解其在临床护理中的疗效和安全性至关重要。除了在接受姑息治疗的人群中进行临床试验存在的固有实际挑战外，使用药用大麻产品开展临床试验还需要额外考虑法律、监管、伦理、可行性、药理学和产品要求。

目的

本手稿旨在探讨在接受姑息治疗的人群中开展药用大麻临床试验时的这些考虑因素。

方法

我们的I/IIb期试验研究了一种用于晚期癌症患者厌食症的汽化药用大麻产品的药代动力学、毒性和次要（疗效）结果（澳大利亚临床试验注册号：ACTRN12616000516482）。采用行动研究方法，试验研究者会议记录作为试验规划和执行的审计线索。对这些数据进行整合和综合，以揭示在接受姑息治疗的人群中开展评估症状控制的药用大麻试验的关键设计考虑因素。