朱翻译
我写的双语小说《好运的代价》The Cost of Fortune陈伟屏住了呼吸。数据安全与监查委员会是独立的数据监查机构，负责在临床试验过程中定期审查数据，保障受试者安全与试验科学性。若其建议未被采纳，尤其是涉及“中期分析”的建议，通常意味着试验过程中可能出现了安全性或有效性问题，但研究者（或赞助方）仍选择继续试验并使用全部数据。这是重大危险信号，是足以动摇整个研究可信度的致命瑕疵！而论文仅在脚注中轻描淡写地提了一句，摘要和核心结论部分对此只字未提！Chen Wei held his breath. The DSMB is an independent data monitoring body responsible for periodically reviewing trial data to ensure participant safety and the scientific integrity of the study. When DSMB recommendations—particularly those regarding interim analysis—are not adopted, it typically signals that potential safety or efficacy issues arose during the trial, yet the researchers (or sponsor) opted to proceed and include all data in the final analysis. This is a major red flag, a fatal flaw that could undermine the entire study’s credibility. Yet the paper only mentioned it in passing in a footnote, with no reference to it whatsoever in the abstract or key conclusions!
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