定量评估标准协议模板对多站点临床试验启动时间的影响
Colleen E Lawrence1, Virginia Nickie M Bruce2, Libby D Salberg3
1Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Journal of clinical and translational science
|October 13, 2023
概括
标准化临床试验协议显著减少了合同谈判时间. 加快临床试验协议 (ACTA) 和联邦示范伙伴关系协议 (FDP-CTSA) 平均节省了分别48天和57天,加速了研究.
科学领域:
- 临床研究行动临床研究行动.
- 翻译科学是翻译的科学.
- 监管事务 监管事务
背景情况:
- 合同延迟是美国启动多站点临床研究的重要障碍.
- 临床和翻译科学奖 (CTSA) 合同处理研究报告称,平均合同谈判持续时间超过100天.
- 这些延迟给赞助商带来了巨大的成本,并阻碍了患者获得新疗法的机会.
研究的目的:
- 评估标准化协议模板对临床试验合同谈判时间表的影响.
- 评估通过使用加速临床试验协议 (ACTA) 和联邦示范伙伴关系临床试验附属协议 (FDP-CTSA) 实现的时间节省.
主要方法:
- 由25个学术机构在NIH支持下开发加速临床试验协议 (ACTA).
- 根据ACTA的消息,联邦示范伙伴关系临床试验补贴协议 (FDP-CTSA) 成立.
- 无论是ACTA还是FDP-CTSA,都在很大程度上是不可谈判的,事先批准的合同模板.
主要成果:
- 使用ACTA导致合同谈判时间平均减少48天.
- 实施FDP-CTSA导致谈判平均节省了57天的时间.
- 这些标准化协议代表了行业和学术利益相关者接受的预先协商的妥协.
结论:
- 标准化,在很大程度上不可谈判的临床试验协议,如ACTA和FDP-CTSA,可以大幅减少合同谈判时间.
- 采用这些CTSA开发的模板为临床研究启动提供了显著的效率提升.
- 减少合同延迟可以加速向患者提供基于证据的治疗方法.
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