重新思考安慰剂：在罕见肿瘤的临床试验中采用合成对照组。

IF 58.7 1区医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY

Nature Medicine Pub Date : 2023-10-12 DOI:10.1038/s41591-023-02578-z

César Serrano, Sara Rothschild, Guillermo Villacampa, Michael C. Heinrich, Suzanne George, Jean-Yves Blay, Jason K. Sicklick, Gary K. Schwartz, Sameer Rastogi, Robin L. Jones, Piotr Rutkowski, Neeta Somaiah, Víctor Navarro, Denisse Evans, Jonathan C. Trent

引用次数: 0

摘要

在研究胃肠道间质瘤和其他罕见肿瘤的新型疗法时，应使用外部比较臂，以促进药物测试和监管审批。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors

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Rethinking placebos: embracing synthetic control arms in clinical trials for rare tumors

External comparator arms should be used when investigating novel therapies for gastrointestinal stromal tumor and other rare tumors to facilitate drug testing and regulatory approvals.

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来源期刊

Nature Medicine 医学-生化与分子生物学

CiteScore

100.90

自引率

0.70%

发文量

525

审稿时长

1 months

期刊介绍： Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors. Nature Medicine consider all types of clinical research, including: -Case-reports and small case series -Clinical trials, whether phase 1, 2, 3 or 4 -Observational studies -Meta-analyses -Biomarker studies -Public and global health studies Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.