在社区中进行临床研究
Ruemu Ejedafeta Birhiray1, Maya Nicole Birhiray2
1Hematology Oncology of Indiana/American Oncology Network, PA, and Marian University College of Osteopathic Medicine, Indianapolis, IN.
Hematology. American Society of Hematology. Education Program
|December 9, 2023
概括
在社区瘤学环境中,对高风险的血液恶性瘤进行临床试验的准入仍然有限,这导致了持续的健康差异. 新的举措旨在扩大患者入学率,并改善多种人群的治疗可用性.
科学领域:
- 血液学恶性瘤是什么
- 瘤学 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 大多数高风险的血液性恶性瘤患者因患者的偏好和信任而在社区瘤实践中接受护理.
- 复杂的治疗方法和有限的临床试验在社区场所的访问有助于结果的差异,特别是对于少数民族,农村和老年患者.
- 尽管自2003年以来国家癌症研究所 (NCI) 的计划,在临床试验参与的差异,特别是在制药研究,一直存在.
研究的目的:
- 分析社区瘤实践中高风险血液恶性瘤临床试验获取的持续差异.
- 评估之前的NCI倡议和最近的立法行动对临床试验招生的影响.
- 提出改善临床试验可用性和在社区环境中代表性的策略.
主要方法:
- 审查国家癌症研究所 (NCI) 计划和立法行动 (例如,FDA Omnibus Act 2022) 旨在改善临床试验多样性.
- 对高风险血液恶性瘤临床试验中代表性不足的因素的分析.
- 检查药物导向临床研究中持续存在的差异.
主要成果:
- 过去的NCI计划 (2003-2023) 并没有完全解决高风险血液恶性瘤临床试验准入方面的差异.
- 临床研究中的代表性不足导致数据缺口,并在社区实践中延迟治疗的可用性.
- "2022年FDA全方位法案"旨在通过强制性多样性计划来解决这些差异.
结论:
- 持续存在的差异凸显了需要加强战略,将临床试验纳入社区瘤学.
- 通过像DRIVE战略这样的倡议和利用NCI计划可以促进试验的可用性.
- 改善社区环境中的临床试验准入对于高风险的血液恶性瘤的公平结果至关重要.
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