随着时间的推移,试验招聘和行为面临越来越多的挑战
Wesley T Kerr1,2,3, Advith S Reddy1, Sung Hyun Seo1
1Department of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
Epilepsia
|July 13, 2023
概括
对焦点发作的临床试验面临着日益增长的招募和保留挑战,每个地点的参与者较少,随着时间的推移,安慰剂反应增加. 这些趋势需要改变试验设计.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 招聘和保留对临床试验的成功至关重要.
- 焦点发作需要有效的治疗方法,需要精心设计的临床试验.
- 临床试验设计的历史趋势可能会影响参与者的参与和数据有效性.
研究的目的:
- 评估随着时间的推移,参与者招募和留住挑战的变化,焦点发作的临床试验.
- 分析随机临床试验中参与者数量,场地参与和完成率的趋势.
- 评估这些试验中安慰剂反应率的演变.
主要方法:
- 自1990年以来,对随机临床试验的系统分析,用于治疗焦点发作的辅助抗发作药物.
- 混合效应通用线性模型被用来分析参与者数量,场地参与和完成率的趋势.
- 统计模型考虑了试验地点的数量和试验特定的变化.
主要成果:
- 几十年来,每个地点的参与者数量大幅减少,最近的试验平均不到五名参与者.
- 随着时间的推移,参与者从招募到随机化的进展有所下降.
- 同时增加的安慰剂反应率,独立于试验地点的数量.
结论:
- 对焦点发作的临床试验在招募和保留参与者方面面临越来越大的困难.
- 随着安慰剂反应率的上升,试验结果的解释面临挑战.
- 呼吁采取行动,重新设计临床试验以应对这些新出现的挑战.
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