关于扩大访问的定性采访研究 日本慈悲使用的临床试验
Haruto Hayashi1, Takehide Nogita2,3, Hideki Maeda1,2
1Department of Regulatory Science, Faculty of Pharmacy, Meiji Pharmaceutical University, Tokyo, Japan.
Patient preference and adherence
|July 16, 2024
概括
日本的扩展访问临床试验 (EACT) 需要系统改进. 制药公司希望有一个单一的患者接入系统,更好的支持,以及对新药进行研究的简化程序.
科学领域:
- 药物开发和监管事务
- 临床试验的管理管理.
- 患者可以获得新型疗法.
背景情况:
- 扩展访问临床试验 (EACT) 提供了对危及生命的疾病临床试验药物的关键访问.
- 日本的EACT系统于2016年推出.
- 了解制药公司对EACT的看法对于系统优化至关重要.
研究的目的:
- 调查日本扩展访问临床试验 (EACT) 的现状和看法.
- 从制药公司收集关于EACT实施的实用性和挑战的见解.
- 根据行业反,确定EACT系统需要改进的领域.
主要方法:
- 与10家制药公司进行半结构面试,在日本开发创新药物.
- 选择的公司开发药物,EACT可能与之相关,不论EACT之前的经验.
- 专注于了解公司对EACT系统的看法和经验.
主要成果:
- 所有接受采访的公司都了解EACT;12项试验进行,关键试验的实施率为2.5%.
- "医生和医疗机构的要求"是EACT实施的主要驱动因素 (90.0%).
- 主要障碍包括"系统适用性" (5家公司),有80.0%的人建议改进,例如财政援助 (60.0%) 和程序简化 (60.0%).
结论:
- 日本制药公司发现目前EACT系统存在重大问题.
- 有强烈的共识,需要对系统进行修订,包括一个单一的患者访问系统,增强支持资源和简化程序.
- 成立八年后,日本的EACT立法似乎需要修订,以更好地促进患者获得关键治疗.
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