高期望：肿瘤学中医用大麻临床试验的格局。

High expectations: The landscape of clinical trials of medical marijuana in oncology.

机构信息

Radiation Oncology, George Washington University School of Medicine and Health Sciences, Washington, DC, United States.

出版信息

Complement Ther Med. 2020 Mar;49:102336. doi: 10.1016/j.ctim.2020.102336. Epub 2020 Feb 3.

DOI:10.1016/j.ctim.2020.102336

PMID:32147080

Abstract

PURPOSE

Given the infancy and evolving complexity of medicinal marijuana, an evolving political landscape, and the growing frequency of its use in cancer care, it is important for oncologists to be actively engaged in developing and successfully implementing clinical trials focusing on medical marijuana. The purpose of this study was to analyze and evaluate trends in clinical trials focused on medical marijuana in oncology.

PATIENTS AND METHODS

Using 3 web-based registries, Clinicaltrials.gov, European Union Clinical Trials Register (EU-CTR), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), we queried for search terms related to marijuana and oncology. This search identified approximately 48 oncology clinical trials involving medical marijuana. We restricted our selection to clinical trials registered between January 2002 and May 2019. Data were summarized using descriptive statistics, and qualitative data were represented as frequency and percentage.

RESULTS

A total of 474,043 trials were queried in the databases and the search strategy returned 48 trials since 2002 that met criteria for analysis in the current study: 36 from ClinicalTrials.gov, 8 from EU CTR, and 4 from ICTRP. Mean trial enrollment was 370 participants, median 53, with range of 6-10000 participants. In total, 25 % trials were phase I, 12.5 % were phase I/II, 27.1 % were phase II, 4 % were phase II/III, 18.8 % were phase III, and 12.5 % were unknown. The recruitment status were "not yet recruiting", "recruiting", "active, not recruiting", "completed", "terminated/withdrawn", and "unknown" in 6 (12.5 %), 14 (29.2 %), 0 (0 %), 20 (41.7 %), 5 (10.4 %), and 3 (6.3 %) trials, respectively. The trial start years were "2002-2005″, 2006-2009, 2010-2013, 2014-2017, and 2018-Present in 4 (8.3 %), 5 (10.4 %), 10 (20.8 %), 15 (31.3 %), and 14 (29.2 %) of trials, respectively. Lastly, synthetic or branded compounds were investigated in 26 (54.2 %) of trials since 2002.

CONCLUSION

Our results indicate that across oncology, there is growing interest in clinical research in the use of medical marijuana.

摘要

目的

鉴于医用大麻的婴儿期和不断演变的复杂性、不断变化的政治格局以及其在癌症治疗中使用频率的不断增加，肿瘤学家积极参与开发和成功实施专注于医用大麻的临床试验非常重要。本研究的目的是分析和评估专注于肿瘤学的医用大麻临床试验的趋势。

患者和方法

我们使用 3 个基于网络的注册处，即 ClinicalTrials.gov、欧盟临床试验注册处（EU-CTR）和世界卫生组织（WHO）国际临床试验注册平台（ICTRP），查询与大麻和肿瘤学相关的搜索词。该搜索确定了大约 48 项涉及医用大麻的肿瘤学临床试验。我们将选择范围限制为 2002 年 1 月至 2019 年 5 月期间注册的临床试验。使用描述性统计数据总结数据，并用频率和百分比表示定性数据。

结果

在数据库中查询了 474,043 项试验，搜索策略返回了自 2002 年以来符合当前研究分析标准的 48 项试验：36 项来自 ClinicalTrials.gov，8 项来自 EU-CTR，4 项来自 ICTRP。平均试验入组人数为 370 人，中位数为 53 人，范围为 6-10000 人。总共，25%的试验为 I 期，12.5%为 I/II 期，27.1%为 II 期，4%为 II/III 期，18.8%为 III 期，12.5%为未知。招募状态分别为“尚未招募”、“正在招募”、“活跃，不招募”、“已完成”、“已终止/撤回”和“未知”的试验分别为 6（12.5%）、14（29.2%）、0（0%）、20（41.7%）、5（10.4%）和 3（6.3%）。试验开始年份分别为“2002-2005”、“2006-2009”、“2010-2013”、“2014-2017”和“2018 年至今”的试验分别为 4（8.3%）、5（10.4%）、10（20.8%）、15（31.3%）和 14（29.2%）。最后，自 2002 年以来，26（54.2%）项试验研究了合成或品牌化合物。