囊性纤维化临床试验的远程终点:来自美国CF基金会远程终点工作组的报告
Jordana E Hoppe1, Jacquelyn Sjoberg2, Gina Hong3
1Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora CO, USA.
概括
随着COVID-19大流行,在囊性纤维化 (CF) 临床研究中加速使用远程终点. 这项研究评估了它们的当前使用,可行性,以及为未来的临床试验做好准备.
科学领域:
- 临床研究 临床研究
- 肺部病理学 肺部病理学
- 生物技术是生物技术.
背景情况:
- 由于COVID-19的流行,临床研究中需要进行虚拟访问和远程评估.
- 这一转变为优化囊性纤维化 (CF) 临床试验的远程终点提供了机会.
- 远程终点可以提高试验的多样性,减少参与者的负担,但需要进行彻底的评估.
研究的目的:
- 描述目前CF临床研究中远程终点的使用情况.
- 确定和解决有关远程端点可行性和性能的关键问题.
- 概述评估CF中远程终点临床试验准备的下一步步骤.
主要方法:
- 召集囊性纤维化基金会远程终点工作组,一个多学科的小组.
- 审查CF研究中远程终点的当前实践和文献.
- 确定关键的未回答问题和未来调查的领域.
主要成果:
- 该研究详细介绍了CF临床试验中远程终点使用现有的情况.
- 突出了与远程端点实施相关的关键挑战和机会.
- 该报告解决了对绩效和可行性进行强有力的评估的需要.
结论:
- 远程终点为改善CF临床试验提供了显著的潜力.
- 需要进一步的研究和验证,以确保远程评估的可靠性和有效性.
- 需要进行战略规划,以确定远程终点是否为广泛采用临床试验做好准备.
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