保护和促进临床试验的代表性:对现有策略的审查和前进的道路
Francesca Maria Di Muro1, Katerina Dangas2, Rebecca Ortega1
1Center for Interventional Cardiovascular Research and Clinical Trials, Icahn School of Medicine at Mount Sinai, New York, New York.
心血管疾病临床试验中的代表人数不足限制了概括性和公平护理. 实现有意义的代表性需要将最佳实践纳入试验设计和协调的利益相关方方法.
科学领域:
- 心血管医学临床研究
- 健康 公平 卫生 公平
- 临床试验设计 临床试验设计
背景情况:
- 尽管取得了进展,但心血管临床试验仍然存在代表性不足的问题.
- 这限制了研究结果的概括性和对新疗法的公平获取.
- 利益相关者越来越多地认识到在试验中代表人口的科学必要性.
研究的目的:
- 审查目前的临床研究代表性政策和倡议.
- 为在临床试验中实现广泛代表性提供战略框架.
- 强调来自代表性试验群体的科学有效性.
主要方法:
- 综合关于临床研究中代表性的最新政策和倡议.
- 制定一个战略框架,将代表性纳入试验设计.
- 对实现有意义的参与者代表性的最佳实践进行分析.
主要成果:
- 在实现超越入学目标的有意义的代表性方面,仍然存在重大挑战.
- 最佳实践包括定制招聘,多元化领导,标准化数据收集和问责度量.
- 决策者,资助者,研究人员和社会之间的协调方法至关重要.
结论:
- 有意义的表现对于心血管临床试验结果的科学有效性和公平应用至关重要.
- 将最佳实践纳入试验设计和实施是关键.
- 统一的利益相关者努力是必要的,以提高试验的代表性和其科学价值.
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