设计中的多样性:增强临床癌症研究中的真实数据
Thao T Vo1, Sangmi Kim2, Ashley Jaksa3
1Merck & Co. Inc., West Point, PA, United States.
概括
不同的临床试验招生对于健康公平和精确医学至关重要. 现实世界数据 (RWD) 可以帮助改善试验群体的代表性,解决当前的多样性差距.
科学领域:
- 临床研究方法
- 医疗公平与获得
- 医疗保健中的数据科学
背景情况:
- 临床试验往往缺乏多样性,少数群体和不健康人群的代表性不足.
- 这种缺乏多样性限制了概括性,并阻碍了精准医学的努力.
- 监管机构和倡议越来越强调需要更具代表性的试验群体.
研究的目的:
- 探索现实数据/证据 (RWD/E) 在提高临床试验多样性和代表性方面的有用性.
- 提出临床开发中的多样性维度框架.
- 讨论利用RWD/E进行包容性试验的机会和挑战.
主要方法:
- 对现有文献和倡议进行前性审查.
- 发展多样性维度框架 (人口,临床,治疗环境).
- 在临床开发阶段讨论RWD/E应用.
主要成果:
- 可以为试验招生目标和策略提供信息.
- 可以识别招募不同患者群体的障碍.
- 对于代表性不足的群体,RWD/E可以提供补充证据,提高外部有效性.
结论:
- 实际数据/证据为改善临床试验多样性提供了显著的潜力.
- 战略性使用RWD/E对于创建更具代表性的瘤试验至关重要.
- 解决试验中的多样性差距对于推进健康公平和个性化医疗至关重要.
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