展望-肺:一个国家临床试验网络试验推进实用性创新癌症临床试验
Allison Booth1, Shauna Hillman1, Kristina Laumann1
1Alliance Statistics and Data Management Center, Mayo Clinic Quantitative Health Sciences, Rochester, MN.
概括
PROSPECT-Lung试验显著简化了可切除非小细胞肺癌的临床试验设计. 这种务实的方法减少了协议长度和数据收集,节省了大量的站点时间并提高了可行性.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 翻译研究是翻译研究.
背景情况:
- 传统的临床试验由于广泛的数据收集,限制性资格和漫长的协议而面临效率低下的问题.
- 这些因素增加了成本,阻碍了患者积累,并因人员短缺和运营负担而加剧.
- 需要更有效和可行的临床试验设计,而不会损害科学严谨性.
研究的目的:
- 评估PROSPECT-Lung试验作为提高可切除非小细胞肺癌临床试验效率和可行性的模型.
- 为了比较PROSPECT-Lung的协议长度和数据收集元素与同一疾病环境中的传统试验 (联盟A081801).
- 量化精简工作及其对试验复杂性和现场工作量的影响.
主要方法:
- PROSPECT-Lung是一项实用的,第三阶段的,开放的,随机的试验,比较基于免疫治疗的治疗策略.
- 该试验重点关注可切除非小细胞肺癌患者的3年无事件存活率和整体存活率.
- 协议长度和数据字段与联盟A081801进行了比较,以评估简化.
主要成果:
- 与A081801.01相比,PROSPECT-Lung在试验复杂性方面取得了显著的减少.
- 记录长度减少了65% (88页到30页),每个患者的数据字段减少了82.6% (2523页到438页).
- 据估计,现场工作量从每名患者的210小时减少到每名患者的36.5小时,在完全积累时节省了超过19万小时.
结论:
- PROSPECT-Lung试验表明,扩大资格和简化物流可以减少患者,调查人员和现场的负担.
- 这种务实的方法保持了科学完整性,并为未来的癌症试验提供了可复制的模型.
- PROSPECT-Lung模型促进了瘤学研究的效率,可访问性和现实世界的相关性.
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