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通过终点选择缩小 RCT 和 RWE 之间的差距。

Bridging the Gap Between RCTs and RWE Through Endpoint Selection.

机构信息

Real World Evidence, Sanofi, Bridgewater, NJ, USA.

AbbVie, Chicago, IL, USA.

出版信息

Ther Innov Regul Sci. 2021 Jan;55(1):90-96. doi: 10.1007/s43441-020-00193-5. Epub 2020 Jul 6.

Abstract

This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.

摘要

本评论由几位行业真实世界证据 (RWE) 专家撰写,并得到 IQVIA 的支持,作为“RWE 领导力论坛”的一部分:该论坛由一群行业领导者组成,他们作为非竞争合作伙伴聚集在一起,以单一专家的声音理解和应对 RWD/E 的挑战和机遇。在这里,论坛讨论了弥合 RCT 和 RWE 之间行业脱节的价值,旨在促进 RWE 在 RCT 环境中的应用。RCT 终点沿着几个轴进行探讨,包括其临床相关性和直接患者受益的衡量标准,然后与现实世界的对应物进行比较,以确定将 RWE 终点纳入 RCT 环境的合适途径或差距。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b80d/7785541/52650684bf0a/43441_2020_193_Fig1_HTML.jpg

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