现实世界的证据在乳腺癌治疗中的可接受性和使用在美国的决策:来自多学科智库的行动呼吁
Sean Khozin1,2, Nancy A Dreyer3,4, Dominic Galante5
1Massachusetts Institute of Technology, Cambridge, MA, USA. sean@phyusionbio.com.
Advances in therapy
|May 12, 2025
概括
现实世界证据 (RWE) 补充了瘤学,特别是乳腺癌的临床试验. 一个智库提出开发以患者为中心的终点,并促进更广泛的利益相关者参与,以加强RWE.
科学领域:
- 在瘤学瘤学.
- 现实世界的证据 (RWE)
- 临床决策 - 临床决策
背景情况:
- 随机对照试验 (RCT) 得到了来自瘤学观察研究的现实世界证据 (RWE) 的补充.
- 现有的RWE框架和资源是有价值的,但需要进一步推进临床接受.
- 一个多学科智库召开会议,以解决障碍,并促进在治疗决策中使用RWE,重点是乳腺癌.
研究的目的:
- 在瘤治疗决策中推进现实世界的证据 (RWE) 的接受和利用.
- 从临床角度确定影响RWE感知和应用的关键领域.
- 为将RWE纳入临床实践和指导方针制定提出可行的战略.
主要方法:
- 召开一个多学科智库,包括各种医疗保健利益相关者.
- 讨论跨数据,方法和思维领域对RWE的看法.
- 识别和同意可起诉的行为.
- 呼吁采取行动的呼吁.
- 对于利益相关者来说.
主要成果:
- 关于主要行动呼吁的协议:制定临床相关的,患者知情的,现实世界的终点.
- 确定次要的行动号召,包括建立一个多学科的共识论坛.
- 强调展示独特的RWE价值和定制指南机构的方法.
结论:
- 开发以患者为中心的真实世界终点对于推进RWE实用程序至关重要.
- 多学科合作和清晰的沟通对于在瘤学中更广泛地采用RWE至关重要.
- 与指南机构的战略合作可以增强现实世界的临床实践证据的影响.
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