对于分散的临床试验进行远程监测和数据收集
Bobby Daly1, Otis W Brawley2, Mary K Gospodarowicz3
1Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, New York.
JAMA network open
|April 12, 2024
概括
分散的临床试验技术在瘤学中采用程度较低,但行业预计会有显著的增长. 未来采用数字招聘和本地网络可以增强患者的中心性.
科学领域:
- 临床试验操作临床试验操作
- 制药行业 制药行业 制药行业
- 以患者为中心.
背景情况:
- 癌症临床试验的患者入学率低部分是由于财务和后勤负担,不成比例地影响服务不足的人群.
- 随着COVID-19大流行,制药公司加速采用分散的临床试验 (DCT) 操作.
研究的目的:
- 评估全球采用DCT技术的情况.
- 确定影响DCT采用的因素.
- 了解行业对更加以患者为中心的试验的愿望.
主要方法:
- 在博新经济国际癌症联盟中对全球生物制药公司进行了一项调查.
- 该调查侧重于注册临床试验,并从10月1日至2022年12月31日收集数据.
- 数据分析包括描述性统计数据,以评估技术采用,以患者为中心的结果,以及障碍/促进者.
主要成果:
- 所有8家受邀公司都做出了回应,占瘤学市场的33%.
- 在瘤学试验中采用DCT通常落后于其他治疗领域.
- 电子日记和电子临床结果评估显示当前采用率最高 (约50%),而当地医生网络的采用率最低 (约7%).
结论:
- 业界预计,在未来5年内,DCT的采用将大幅增加,在11项调查中的8项瘤技术中,预计将增加40%.
- 数字招聘,本地成像和本地医生网络被确定为改善患者中心性的关键技术.
- 越来越多地采用DCT技术可以促进更容易获得,更少的负担和包容性临床试验.
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