ELAINE 2研究的操作指标将传统方法与即时模型相结合
Sibel Blau1, Julio Antonio Peguero2, Halle C F Moore3
1Rainier Hematology Oncology/Northwest Medical Specialties, Seattle, WA.
与传统方法相比,Tempus TIME Trial网络显著加速了瘤学临床试验的网站激活和患者招募. 这种Just-in-TIME方法,与传统模型相结合,增强了对生物标志物驱动研究的招聘.
科学领域:
- 在瘤学瘤学.
- 临床试验操作 临床试验操作
- 生物标志物驱动的研究
背景情况:
- 在瘤生物学生物标志物驱动研究中招生面临着许多障碍.
- 在ELAINE 2研究中,研究了lazofoxifene和abemaciclib用于具有ESR1突变的晚期ER+/HER2-乳腺癌.
研究的目的:
- 为了比较传统和Tempus TIME Trial网络网站激活和注册流程之间的运营指标.
- 评估Just-in-TIME模型在加速临床试验启动和患者招募方面的效率.
主要方法:
- ELAINE 2研究 (NCT04432454) 采用了传统方法 (患者识别前的部位激活) 和时间试验方法 (患者识别后的部位激活).
- 运营指标包括场地协议执行,IRB批准和第一次同意的时间在两个模型之间进行了比较.
主要成果:
- 时间 试验站点表现出明显更快的网站协议执行 (7.6天 vs 200.5天) 和IRB批准 (3.0天 vs 27.5天).
- 时间试验网络导致更早的患者入学,第一位患者比传统网站提前115天入学.
- 该试验在8.5个月内招募了29名患者,可能比预期的12-18个月更快.
结论:
- 采用Just-in-TIME模型的Tempus TIME Trial网络显著减少了启动时间,并加速了患者的招生.
- 将Just-in-TIME模型与传统方法相结合,可以有效地克服生物标志物驱动的瘤学试验的入学障碍.
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