临床试验主要终点的 "不可承受之轻"。

IF 3.5 2区 生物学 Q3 CELL BIOLOGY Molecular and Cellular Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-08-30 DOI:10.1007/s11010-024-05098-7
A J Marian
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引用次数: 0

摘要

在本视角中,我将讨论近期一些随机 II/III 期临床试验中使用的软性主要终点的局限性。遗憾的是,许多临床医生和研究人员在解读数据时缺乏批判性,没有认识到此类研究结果的局限性。我建议不要过度解读软性主要终点的干预效果。
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"The unbearable lightness" of the primary end point in clinical trials.

In this Perspective, I discuss the limitations of a soft primary endpoint that is used in some of the recent randomized phase II/III clinical trials. Unfortunately, many clinicians and investigators do not interpret the data critically to recognize the limitations of such findings. I advise against over-interpreting the effects of an intervention on a soft primary endpoint.

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来源期刊
Molecular and Cellular Biochemistry
Molecular and Cellular Biochemistry 生物-细胞生物学
CiteScore
8.30
自引率
2.30%
发文量
293
审稿时长
1.7 months
期刊介绍: Molecular and Cellular Biochemistry: An International Journal for Chemical Biology in Health and Disease publishes original research papers and short communications in all areas of the biochemical sciences, emphasizing novel findings relevant to the biochemical basis of cellular function and disease processes, as well as the mechanics of action of hormones and chemical agents. Coverage includes membrane transport, receptor mechanism, immune response, secretory processes, and cytoskeletal function, as well as biochemical structure-function relationships in the cell. In addition to the reports of original research, the journal publishes state of the art reviews. Specific subjects covered by Molecular and Cellular Biochemistry include cellular metabolism, cellular pathophysiology, enzymology, ion transport, lipid biochemistry, membrane biochemistry, molecular biology, nuclear structure and function, and protein chemistry.
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