培训新的DMC成员:呼吁采取行动
Frank Rockhold1,2, Kenneth Mahaffey3, David DeMets4
1Duke University Medical Center, Durham, USA. frank.rockhold@duke.edu.
Therapeutic innovation & regulatory science
|September 25, 2023
概括
由于临床试验的增加,对受过培训的数据监测委员会 (DMC) 成员的需求日益增加. 该研究建议在实际试验中为新成员提供现场培训,以弥合这一差距.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 监管科学 监管科学
背景情况:
- 从历史上看,数据监测委员会 (DMC) 的专业知识是通过在职培训获得的.
- 已经确定了对训练有素的DMC成员的需求和供应之间的显著和不断增长的差距.
- 这种短缺部分归因于正在进行的临床试验数量大幅增加.
研究的目的:
- 解决更多在DMC操作中受过培训的临床医生和生物统计学家的关键需求.
- 为缺乏先前 DMC 经验的个人提出实践培训方法.
主要方法:
- 充分利用现有的培训材料,并推一个指导过程.
- 建议将新的调查人员纳入DMC责任,作为实际DMC的成员.
- 通过直接参与正在进行的试验,促进DMC过程的学习.
主要成果:
- 拟议的方法允许实践,实时培训DMC程序.
- 这种方法旨在增加合格的DMC成员的数量.
- 它支持临床试验人员和数据科学家的专业知识的发展.
结论:
- 学术,监管和行业领导人应该支持将缺乏经验的调查人员纳入DMC.
- 这种实践培训策略可以有效地解决DMC技术人员短缺的问题.
- 将新成员纳入活跃试验为DMC成员发展提供了可行的解决方案.
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