什么时候现实世界数据将实现其在瘤学中提供及时见解的承诺?
Marc L Berger1, Patricia A Ganz2, Kelly H Zou3
1Marc L. Berger, LLC, New York, NY.
JCO clinical cancer informatics
|July 1, 2024
概括
随机试验对老年人群的癌症护理有局限性. 现实世界数据 (RWD) 提供了及时的见解,但需要标准化的基础设施和先进的分析来获得可靠的现实世界证据 (RWE).
科学领域:
- 在瘤学瘤学.
- 现实世界的数据分析.
- 临床研究方法论临床研究方法论
背景情况:
- 随机试验提供了高质量的数据,但缺乏通用性,特别是对于老年癌症患者具有并发症.
- 人口老龄化,经常有多种健康问题,需要及时和相关的数据来有效解释癌症治疗.
- 现有的数据来源,如电子健康记录 (EHR),由于非结构化数据和缺少关键参数,在瘤学中存在挑战.
研究的目的:
- 突出传统随机试验在捕捉不同人群癌症护理复杂性的局限性.
- 强调现实世界数据 (RWD) 的潜力,为癌症患者的治疗结果提供及时和可概括的见解.
- 解决挑战,并提出解决方案,以产生可靠的真实世界证据 (RWE) 在瘤学.
主要方法:
- 审查临床研究当前的数据收集和分析方法,重点是随机试验和真实世界的数据来源.
- 在瘤学中利用真实世界数据 (RWD) 的挑战,包括在EHR中数据标准化和可访问性问题.
- 探索先进的分析,如人工智能,以增强来自各种RWD来源的数据提取和解释.
主要成果:
- 现实世界数据 (RWD) 可以为特定子组的治疗益处和结果提供关键的见解,包括老年人和有社会健康需求的人.
- 可靠的真实世界证据 (RWE) 可以从各种来源生成,如实用试验,注册表,电子健康记录和数字技术.
- 人工智能有望从电子健康记录中提取细节信息,但需要特定目的的验证.
结论:
- 致力于跨源数据标准化的承诺对于创建适合目的的RWD至关重要.
- 开发强大的基础设施是必要的,以产生可靠的RWD,以了解干预的有效性.
- 标准化的RWD和先进的分析对于在现实环境中及时了解癌症治疗有效性至关重要.
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