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患者报告的结局在早期阶段的试验中,对于患有骨髓质疏松症候群的患者

Tito Mendoza¹, Amanda L King¹, Elizabeth Vera¹

¹Office of Patient-Centered Outcomes Research, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

Seminars in hematology

|November 14, 2024

概括

患者报告的结局 (PROs) 对于在骨髓质疏松症候群 (MDS) 和急性髓性白血病 (AML) 试验中评估新的癌症疗法至关重要. 专业医疗人员捕捉患者的经验,补充传统的不良事件报告,以更好地评估治疗.

科学领域:

在瘤学瘤学.
临床试验方法论临床试验方法论
患者报告的结果

背景情况:

骨髓质疏松症候群 (MDS) 和急性骨髓性白血病 (AML) 患者面临着疾病和治疗带来的显著症状负担.
早期临床试验不仅要评估抗瘤效果,还要评估治疗对患者健康和功能的影响.

研究的目的:

审查患者报告结果 (PRO) 在MDS和AML药物开发中的作用和重要性.
概述在早期试验阶段实施PRO的基本心理测量属性和实际考虑.

主要方法:

在癌症临床试验中对PRO的文献综述.
对MDS/AML早期阶段研究的PRO应用策略的讨论.
在国家癌症研究所开发的标准化PRO方法的概述.

主要成果:

医疗保健专家提供了患者报告的有价值的症状毒性数据,补充了传统的不良事件报告.
对于全面评估新疗法对患者感觉和功能影响的PROs至关重要.
对于MDS/AML的早期阶段试验,有一个标准化的PRO方法.

结论:

将PRO纳入早期MDS/AML试验对于全面评估治疗疗效和患者体验至关重要.
专业人员提高对治疗耐受性和以患者为中心的益处的理解.
标准化的PRO方法有助于在瘤药物开发中进行可靠的数据收集和解释.

关键词:

急性骨髓性白血病 (AML) 是一种急性骨髓性白血病.早期阶段试验早期阶段试验骨髓分裂性综合征骨髓分裂性综合征患者报告的结果.症状症状症状

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