在COVID-19大流行期间进行非大流行性研究:一个案例研究和文献审查
Micah J June1,2, Mary I Otiti2,3, Nicodemus O Mbanda2
1Department of Public Health, Pharmacology and Toxicology, University of Nairobi, Nairobi, Kenya.
PLOS global public health
|December 26, 2025
概括
在COVID-19大流行期间进行非大流行性临床研究需要适应性策略. 灵活的,以社区为基础的方法保持了研究完整性和参与者的福利,尽管面临公共卫生挑战.
科学领域:
- 临床研究 临床研究
- 公共卫生紧急情况 公共卫生紧急情况
- 全球健康 全球健康
背景情况:
- 在全球范围内,COVID-19流行病严重扰乱了非流行病研究.
- 卫生系统面临着压力,需要对正在进行的研究进行伦理和监管调整.
- 在公共卫生危机期间进行临床试验存在独特的后勤和道德障碍.
研究的目的:
- 追溯地检查在COVID-19大流行期间在肯尼亚西部对婴儿营养补充剂进行非大流行性临床研究所吸取的伦理和监管教训.
- 确定适应性策略,以促进在与流行病相关的限制下继续临床研究.
- 为未来的研究设计提供见解,确保在公共卫生紧急情况期间的弹性.
主要方法:
- 对伦理和监管提交,进展报告和会议记录的回顾性文档案例分析.
- 主题编码的框架分析方法,得到独立的双重审查的支持 (科恩的卡帕≥0.6).
- 审查相关的同行评审文献在流行病期间的研究行为.
主要成果:
- 公共卫生限制导致延误,需要采取适应措施,如减少身体接触,卫星中心和数字监控.
- 同时提交给道德审查委员会和监管机构,加快协议修订批准.
- 尽管面临挑战,该研究取得了很高的随访完成率 (91%) 和家庭访问成功率 (96%).
结论:
- 灵活,社区知情和道德响应的研究实践对于在不利条件下维持临床试验至关重要.
- 强有力的利益相关者合作,沟通和降低风险对于保持研究完整性和参与者福利至关重要.
- 未来的研究设计必须嵌入应急规划,社区伙伴关系和监管适应性,以应对流行病的准备.
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