临床试验的状态在儿科炎性肠病的临床试验
Jeffrey S Hyams1, Richard K Russell2
1Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, 282 Washington Street, Hartford, CT 06106, USA; University of Connecticut School of Medicine, Farmington, CT, USA.
对于儿科炎性肠病 (IBD) 的生物和小分子疗法的可用性远远落后于成人选择. 解决这个问题需要克服数据缺口,并激励早期儿科药物开发.
科学领域:
- 儿科胃肠病学 儿科胃肠病学
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
背景情况:
- 对于儿科和成人炎症性肠病 (IBD) 的生物和小分子疗法存在显著差异.
- 目前,只有两种抗瘤坏死因子 (anti-TNF) 药物被批准用于儿科IBD使用,与成人更广泛的治疗方案不同.
- 这种治疗差距归因于将成人疗效数据推断到儿科患者群体中的挑战,以及行业对早期儿科药物开发投资回报的担忧.
研究的目的:
- 为了突出儿童炎症性肠病 (IBD) 与成年人相比,可用的治疗方法的巨大差距.
- 确定阻碍开发和批准儿童IBD新疗法的关键障碍.
- 提出可行的策略,以改善儿科IBD治疗的环境.
主要方法:
- 在儿科和成人群体中对当前IBD疗法的文献综述.
- 对儿童药物开发的监管途径和行业投资趋势的分析.
- 综合专家意见的常识方法,以弥合治疗差距.
主要成果:
- 有限数量的已批准的生物和小分子治疗方法用于儿科IBD.
- 成年人数据推断的挑战和行业不愿意投资于早期儿科发展是差距的主要原因.
- 现有的抗TNF药物是儿童生物治疗的主要支柱.
结论:
- 迫切需要改善儿童IBD患者获得多种治疗选择的机会.
- 建议侧重于促进成人数据的接受,并为儿科药物开发创造更有利的投资环境.
- 合作努力对于推进儿科IBD治疗选择至关重要.
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