设计实用临床试验的电子同意协议:来自UKCRC临床试验单位的案例研究
M Hammond1, P Ashford2, J High2
1Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK. M.hammond@uea.ac.uk.
Trials
|August 19, 2024
概括
临床试验中的电子同意 (e-consent) 提供了效率和可访问性的好处. 根据特定的试验设计和参与者需求量身定制电子同意模型对于成功实施至关重要.
科学领域:
- 临床试验方法论 临床试验方法论
- 信息化同意的流程,信息化同意的流程.
- 数字健康技术数字健康技术
背景情况:
- 在COVID-19后的学术临床试验中,电子同意 (e-consent) 的采用越来越多.
- 电子同意提供了诸如效率,可访问性和减少网站负担等优势.
- 需要考虑各种实施方案,以便在研究协议中获得电子同意.
研究的目的:
- 展示电子同意 (e-consent) 模型如何适用于各种学术临床试验.
- 为了说明实施电子同意的好处,参与者接受度和设计考虑因素.
- 提供来自诺维奇临床试验部门的五个案例研究的实际例子.
主要方法:
- 分析了五项随机试验,其设计,疾病区域,干预措施和患者人群各异.
- 电子同意被提供为替代或唯一的同意方法,以适应参与者的偏好.
- 实施细节,包括信息表格式和签名方法,根据试验特定的需求和人群进行了调整.
主要成果:
- 电子同意在分散的试验中促进了远程同意,并在紧急情况下提高了效率.
- 针对技术实施和参与者程序的定制方法对于成功采用至关重要.
- 在可用的情况下,收集了参与者接受度和吸收数据.
结论:
- 临床试验中电子同意的实施受到试验设计,人群特征,成本效益和风险的影响.
- 电子同意不是通用的解决方案,在协议开发过程中需要周到的规划.
- 与患者,公共贡献者,现场工作人员和利益相关方的合作对于有效的电子同意集成至关重要.
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