真实世界证据的可接受性和在美国乳腺癌治疗决策中的使用:来自多学科智库的行动呼吁。

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Sean Khozin, Nancy A Dreyer, Dominic Galante, Raymond Liu, Peter Neumann, Nathan Nussbaum, Joyce O'Shaughnessy, Debra Patt, Mothaffar Rimawi, Hope Rugo, Sara M Tolaney, Marisa Weiss, Adam Brufsky
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引用次数: 0

摘要

作为随机对照试验的补充,来自观察分析的真实世界证据(RWE)可以扩展肿瘤学的临床见解。虽然医疗保健利益相关者已经发布了严格的RWE框架和资源,但建立了一个多学科智囊团,以进一步促进RWE在治疗决策中的接受和使用,重点是乳腺癌(同时认识到更广泛的肿瘤学相关性)。成员们从临床角度讨论了对RWE的看法,涉及数据、方法和思维方式等领域,以及对利益相关者的“行动呼吁”。达成了主要的“行动呼吁”协议,以发展临床相关的、患者知情的、现实世界的终点,以及次要的“行动呼吁”:建立一个多学科共识论坛;发布具有独特RWE价值的例子;以现有框架和资源为基础;并为指导机构定制一种展示效用的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank.

Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidisciplinary think tank was established to further advance acceptance and use of RWE in treatment decision-making, with the focus on breast cancer (while recognizing relevance in oncology more broadly). Members discussed perceptions of RWE from a clinical perspective, across domains of data, methodology, and mindset, and "calls-to-action" for stakeholders. Agreement was reached on a primary "call-to-action," to develop clinically-relevant, patient-informed, real-world endpoints, and secondary "calls-to-action": establish a multidisciplinary consensus forum; publish examples of unique RWE value; build upon existing frameworks and resources; and tailor an approach for exhibiting utility to guideline bodies.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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