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改善英国公共研究机构临床试验透明度的障碍和最佳实践:一项定性访谈研究
Nicholas J DeVito1, Jessica Morley1, Ben Goldacre1
1Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, United Kingdom.
Health policy (Amsterdam, Netherlands)
|February 28, 2024
概括
在政府施压后,英国公共研究机构制定了针对临床试验透明度的新政策. 虽然取得了进展,但在实现研究报告的全面透明度方面仍然存在挑战.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床试验管理 临床试验管理
- 研究治理研究治理
背景情况:
- 自2017年以来,英国政府的举措强调从公共研究机构传播临床试验.
- 利益相关者的反应和内部政策的修改对于提高透明度至关重要.
研究的目的:
- 了解英国公共研究机构如何适应透明度压力.
- 确定最佳实践和提高临床试验透明度的障碍.
主要方法:
- 与来自英国公共机构的研究治理和试验管理人员进行半结构面试.
- 在采访数据的框架方法的帮助下进行主题分析.
主要成果:
- 新的政策和程序被广泛实施,以支持调查人员履行透明度承诺.
- 由于严格的法规,药品试验得到了最多的关注.
- 国家专业网络促进知识共享和最佳实践传播.
结论:
- 投资于机构透明度治理对于最佳实践至关重要.
- 大学和医院共同负责研究中的监管合规.
- 英国机构的努力为全球透明度倡议提供了洞察力.
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