对新兴病原体试验的良好参与性实践的实际应用:开发用于ACTIV-3, -3b和ACTIV相关的COVID-19试验的材料
Paola Del Carmen Guerra-de-Blas1, Rubria Marines-Price2, Olga Milman3
1The Mexican Emerging Infectious Diseases Clinical Research Network (LaRed), Mexico City, Mexico.
Journal of clinical and translational science
|November 29, 2024
概括
良好的参与实践 (GPP) 增强了COVID-19临床试验材料. 利益相关者的投入和可访问的格式改善了全球的研究实施,解决了大流行期间的各种需求.
科学领域:
- 临床研究 临床研究
- 公共卫生 公共卫生
- 全球流行病应对行动
背景情况:
- 由于COVID-19的流行,全球临床研究工作需要迅速开展.
- 有效的研究实施需要适应性,利益相关者知情的材料.
- 之前的研究缺乏对全球试验材料的标准化,参与式方法.
研究的目的:
- 为COVID-19临床试验概述基于良好参与实践 (GPP) 的材料的开发和应用.
- 通过现场人员调查来评估这些材料的有用性.
- 确定未来全球研究网络所学到的经验教训.
主要方法:
- 利用良好的参与性实践 (GPP) 框架进行材料开发.
- 在整个研究过程中,参与了全球利益相关者网络.
- 对临床试验现场人员进行了调查,以评估材料的实用性.
主要成果:
- 翻页书和概述视频被认为是非常有用的材料.
- 利益相关者的意见对于创建可理解,文化相关的参与者材料至关重要.
- 材料需要适应不同的机构资源和政策.
结论:
- 在开发克服障碍的有效临床研究材料方面,GPP至关重要.
- 利益相关者参与和文化敏感的设计增强了研究的实施.
- 优化材料策略可以改善正在进行和未来研究的资源配置.
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