撒哈拉以南非洲地区去中心化临床试验的机遇和挑战:定性研究
Eric I Nebie1,2,3, Hélène N Sawadogo3, Peter van Eeuwijk4,2
1University of Basel, Basel, Switzerland neric83@yahoo.fr.
BMJ open
|September 22, 2023
概括
临床研究的数字化转型,包括去中心化临床试验 (DCT),提供了效率提升,但需要解决撒哈拉以南非洲的技术,数据质量,伦理和上下文挑战.
科学领域:
- 数字健康数字健康
- 临床研究方法论临床研究方法论
- 撒哈拉以南非洲地区.
背景情况:
- 随着COVID-19的流行,数字健康解决方案和分散的临床试验 (DCT) 的采用加速了.
- 评估撒哈拉以南非洲临床研究的数字化转型对于提高试验效率和患者参与至关重要.
研究的目的:
- 评估撒哈拉以南非洲临床研究数字化转型带来的机遇和挑战.
- 从参与临床试验的各个利益相关者的角度收集观点.
主要方法:
- 一项定性研究采用了40个深入的半结构面试.
- 与调查人员,合同研究组织和赞助商进行的采访.
- 用于数据解释的专题分析方法.
主要成果:
- 利益相关者认为DCT有利于试验效率,质量和减少参与者负担.
- 确定的主要挑战包括技术可用性,数据质量转变,伦理/监管障碍和上下文因素.
- 在完全实施DCT之前,需要过渡期来应对这些挑战.
结论:
- 转向以患者为中心的临床试验必须适应撒哈拉以南非洲的背景.
- 成功的转型需要投资,培训,明确的沟通和所有利益相关者的承诺.
- 社区的支持和参与对于在临床研究中采用数字健康至关重要.
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