试验的潜在注册:我们在哪里,为什么,以及我们如何改善
Denis Mongin1, Diana Buitrago-Garcia1, Sami Capderou1
1Division of Rheumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
Journal of clinical epidemiology
|October 31, 2024
概括
风湿病学随机对照临床试验 (RCT) 的预期注册情况有所改善,但仍未达到最佳水平. 缺乏意识和组织问题阻碍了合规,研究人员建议将道德认可与注册联系起来.
科学领域:
- 临床试验 临床试验
- 风湿病学研究 风湿病学研究
- 医学研究 透明度 医疗研究 透明度
背景情况:
- 随机对照临床试验 (RCT) 的未来注册对于透明和可信的研究行为至关重要.
- 在临床研究中,遵守未来的注册指南仍然是一个问题,需要对当前的做法和障碍进行评估.
- 风湿学试验作为一个案例研究来评估是否符合潜在的注册要求.
研究的目的:
- 估计未来注册的风湿病学RCT的比例,并分析影响注册时间的趋势和因素.
- 确定未能遵守潜在注册的原因,并探索改善合规性的策略.
- 为提高临床试验行为透明度提供见解.
主要方法:
- 2009年至2022年期间发表的风湿学RCT的系统搜索和审查.
- 多变量后勤回归分析,以确定与潜在试验注册相关的因素.
- 对非前性注册试验的研究人员进行调查,以确定不遵守的原因和建议的解决方案.
主要成果:
- 在1093个RCT中,41.4%没有被前性地注册 (11.9%从未,29.5%后性).
- 预期注册量每年增加3%,到2022年达到73.2%.
- 与潜在注册相关的因素包括更大的样本规模,跨国招聘和更具影响力的期刊;缺乏知识和组织问题是不加入的主要原因.
结论:
- 尽管情况有所改善,但在风湿病学试验中对潜在注册的遵守仍然不令人满意.
- 需要针对期刊编辑,医疗保健专业人员和研究人员制定有针对性的策略,以改善合规性.
- 将伦理认可与试验注册联系起来被认为是提高潜在注册率的潜在解决方案.
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