学术界和工业界就首次在人体上进行临床试验的可行性工具达成协议
Paloma Moraga1, Paula Prieto1, Almari Conradie2
1Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.
Clinical and translational science
|October 11, 2023
概括
开发了一种新的可行性工具,用于验证学术临床试验单位 (CTU) 进行首次在人身上 (FTIH) 药物试验. 该工具确保CTU符合严格的安全和监管标准,使认可单位能够进行FTIH研究.
科学领域:
- 药物开发 药物开发
- 临床试验 临床试验
- 监管科学 监管科学
背景情况:
- 首次在人身上 (FTIH) 试验对于评估新药的安全性和有效性至关重要.
- 进行FTIH试验需要专业的I期临床试验单位 (CTU),遵循良好的临床实践 (GCP).
- 结核病欧洲制度加速器 (ERA4TB) 项目旨在通过公私合作伙伴关系简化药物开发.
研究的目的:
- 开发一个协作可行性工具,用于验证FTIH试验的学术CTU.
- 建立基于ICH GCP和EMA法规的CTU验证的最低标准.
- 在ERA4TB联盟中认证学术CTU进行FTIH试验.
主要方法:
- 创建了一个由九部分组成的可行性表格,以收集关于CTU属性的数据.
- 工业和学术合作伙伴共同确定了CTU遵守GCP和EMA法规的最低标准.
- 利用开发的工具,评估了可用的CTU对FTIH试验的资格.
主要成果:
- 可行性工具促进了五个学术CTU的验证和认证.
- 这些认可的CTU现在已准备好进行FTIH试验.
- 该工具建立了一种新的,协作式的CTU验证方法.
结论:
- ERA4TB可行性工具提供了一种标准化的方法,用于验证FTIH试验的学术CTU.
- 这个倡议代表了第一个行业-学术合作,用于在ERA4TB.内CTU验证.
- 经过验证的CTU增强了开展早期药物开发研究的能力.
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