临床试验和年轻人患有炎症性肠病
Sneha Dave1,2, Sydney Reed1,2, Mara Shapiro1,2,3
1Generation Patient, United States.
患有炎症性肠病 (IBD) 的年轻人在临床试验中代表性不足. 加强他们的参与需要解决研究障碍,并实施特定年龄的策略,以获得更好的结果.
科学领域:
- 胃肠病学 胃肠病学
- 临床研究 临床研究
- 患者倡导 患者倡导
背景情况:
- 患有IBD的年轻人 (18-35岁) 具有独特的特征.
- 这一群人群在临床试验中显著不足.
- 目前的研究往往未能捕捉到年轻成人IBD患者的具体需求.
研究的目的:
- 综合了圆桌讨论中关于年轻成年IBD患者在临床试验中的代表性的见解.
- 在研究中确定与这个人口相关的关键主题和挑战.
- 探索改善年轻成年人参与和IBD研究成果的机会.
主要方法:
- 一个圆桌讨论,由克罗恩和结肠炎年轻人网络 (CCYAN) 促进.
- 涉及有IBD的年轻成人患者和各种各样的医疗专业人员 (医生,护士,心理学家,学员).
- 讨论主题的定性综合.讨论主题.
主要成果:
- 将年轻人定义为一个独特的人口群体,需要具体的研究考虑.
- 突出了年轻成年人参与临床试验和试验后责任的障碍.
- 在监管和立法政策中确定了促进代表性的机会.
结论:
- 患有IBD的年轻人需要在临床研究中采取量身定制的方法.
- 解决参与障碍和利用政策变化对于更好的代表性至关重要.
- 按年龄分类数据对于改善这一群体的结果至关重要.
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