一个评估临床试验现场准备情况的框架.
John B Buse1, Christopher P Austin2, S Claiborne Johnston3
1Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Journal of clinical and translational science
|July 17, 2023
概括
临床试验现场准备的新框架简化了流程,减少了效率低下和成本. 这种方法有助于新的和经验丰富的研究场所,改善临床试验的进行和可访问性.
科学领域:
- 临床研究行动临床研究行动.
- 翻译医学是一种翻译医学.
背景情况:
- 临床试验过程面临显著的低效率和高成本,延迟了新医疗治疗的交付.
- 赞助商现有的试验场合格流程为改进提供了基础.
研究的目的:
- 引入一个全面的临床试验现场准备框架.
- 解决临床试验进行中的冗余和低效问题.
主要方法:
- 制定一个涵盖六个关键领域的框架:研究团队,基础设施,研究管理,数据收集和管理,质量监督,伦理和安全.
- 利用赞助商的现有试验场资格.
主要成果:
- 该框架旨在减少试验进行中的低效率.
- 它有助于准备进入临床试验企业的新站点.
- 有潜力改善临床试验对服务不足的社区的覆盖.
结论:
- 现场准备框架的实施为各种利益相关者带来了好处,包括赞助商,合同研究组织,参与者和公众.
- 该框架是新手网站的指南,也是经验丰富的网站的评估工具.
- 补充材料提供了对监管文件和资源的访问,并邀请了对系统,DEIA和分散试验的观点.
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