规划和进行大型全球观测研究时要考虑的因素:来自对2型糖尿病患者的DISCOVER研究的经验
Pernilla Aarskog1, Javier Cid-Ruzafa2, Hungta Chen3
1AstraZeneca, Sodertalje, Stockholm, Sweden.
Primary care diabetes
|August 6, 2023
概括
在38个国家,DISCOVER研究追踪了超过15,000名2型糖尿病患者开始二线治疗的情况. 这项观察性研究提供了全球疾病管理和流行病学方面的宝贵现实数据.
科学领域:
- 全球卫生研究全球卫生研究
- 糖尿病流行病学 糖尿病流行病学
- 观察性研究是指观察性研究.
背景情况:
- 2型糖尿病的管理需要了解现实世界的治疗模式.
- 对于许多地区,关于糖尿病护理的流行病学数据有限.
研究的目的:
- 总结DISCOVER全球观测研究计划的规划和实施情况.
- 为开展类似大规模研究的研究人员提供见解.
主要方法:
- 全球观测研究涉及超过15,000名2型糖尿病患者.
- 在38个国家跟踪了二线降血糖治疗的开始.
- 在3年内采集标准化电子数据 (招生,6,12,24,36个月).
主要成果:
- 收集了对开始二线治疗的患者的综合3年数据.
- 建立了一个长期注册的基础,以扩大范围和持续时间.
- 确定了规划和执行大型观测研究的关键成功因素.
结论:
- 像DISCOVER这样的观察性研究对于理解现实世界疾病流行病学和管理至关重要.
- 这些研究为监管机构提供信息,并支持营销后监督.
- 该研究强调了成功进行糖尿病大规模国际研究的关键考虑因素.
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