医用大麻临床试验在接受息治疗的人群中的设计考虑因素
Valentina Razmovski-Naumovski1, Jennifer H Martin2, Richard Chye3
1South 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.
在息治疗中使用药用大麻进行临床试验需要仔细规划. 关键考虑因素包括立法,产品标准化和伦理安全,以确保成功的症状管理研究.
科学领域:
- 息护理研究 息护理研究
- 临床药理学 临床药理学
- 大麻科学 大麻科学
背景情况:
- 在临床试验中评估药用大麻对于基于证据的患者护理至关重要.
- 息护理环境为临床试验带来了独特的挑战,加之是药用大麻的特定要求.
研究的目的:
- 探索在息护理患者中运行涉及药用大麻的临床试验的关键考虑因素.
- 确定影响此类试验设计和执行的关键因素.
主要方法:
- 一个I/IIb期试验研究了一种蒸发的医用大麻产品用于晚期癌症患者的厌食症.
- 行动研究方法,利用调查员会议记录,为试验规划和执行提供了审计轨道.
- 数据进行了综合,以确定在息治疗中医用大麻试验的关键设计考虑因素.
主要成果:
- 出现了六个主要考虑因素:法律合规性,大麻素可信性,产品标准化 (内容,管理,剂量,包装),道德/安全协议,试验地点优化和药房物流.
- 讨论了未来医用大麻试验的学习和建议.
结论:
- 这项研究突出了设计和进行药用大麻试验的复杂性和经验教训,用于缓解护理中的症状管理.
- 获得的见解可以指导未来癌症和其他慢性疾病试验的最佳设计和运行.
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