印度临床试验参与者对临床试验的知识和意识:一个基于多中心问卷的横截面研究
Gopal S Pillai1, C S Sheeba2, Manabjyoti Barman3
1Department of Ophthalmology and Chief of Vitreo- Retinal Services, Amrita Institute of Medical Sciences, Kochi, India.
Indian journal of ophthalmology
|December 15, 2023
概括
这项研究调查了印度的临床试验 (CT) 参与者,发现大多数人都有知识,但缺乏对自己的权利的认识. 对CT的积极态度在参与后得到改善,突出了需要更好地传播信息的必要性.
科学领域:
- 临床研究是临床研究.
- 眼科的试验 眼科的试验
- 参与者招聘和留住参与者
背景情况:
- 参与者的知识和态度对于临床试验 (CT) 的成功至关重要.
- 了解这些因素是改善在CTs招聘和保留的关键.
研究的目的:
- 评估临床试验参与者的知识和意识态度.
- 在印度眼科临床试验网络 (IOCTN) 中评估参与者的理解和感知.
主要方法:
- 在IOCTN中对121名CT参与者进行了截面面对面调查.
- 使用经过验证的问卷来收集人口统计,知识和意识态度数据.
- 分析了总的意识态度得分,以确定参与者的知识水平.
主要成果:
- 90%的参与者对CT有一般的了解,但只有7%的人回忆起签署同意书.
- 意识-态度得分因地点而异,与教育水平有负相关性.
- 关键的积极态度包括不破坏家庭生活和财务稳定;负面态度集中在信息分享不足.
结论:
- 确定了影响CTs参与者的知识和态度的因素.
- 强调需要提高对CT福利,参与者权利和自愿参与的认识.
- 参与之前和之后的态度显示出积极的转变,表明通过更好的沟通改善参与的潜力.
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