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[临床试验出版物中不良事件的描述:仍有很大改进空间。]

[Description of adverse events in publications of clinical trials: much room for improvement.].

作者信息

Di Maio Massimo, Antonuzzo Andrea, Bossi Paolo

机构信息

Dipartimento di Oncologia, Università di Torino, AO Ordine Mauriziano, Ospedale Umberto I, Torino.

Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa.

出版信息

Recenti Prog Med. 2019 Jul-Aug;110(7):323-324. doi: 10.1701/3197.31742.

DOI:10.1701/3197.31742
PMID:31379365
Abstract

Description of toxicity is crucial for a thorough evaluation of cancer treatments, but it is often suboptimal. A systematic review of target drugs and immunotherapy approved by Food and Drug Administration between 2000 and 2015 showed, for instance, that 95% of publications did not describe late toxicities, 94% did not report the duration of adverse events while, in 75% of papers, the list of toxicities was limited to the most frequent ones. The availability of online appendixes would make it possible not to limit the published information, improving the accuracy of the description of adverse events.

摘要

毒性描述对于全面评估癌症治疗至关重要,但往往并不理想。例如,一项对2000年至2015年间美国食品药品监督管理局批准的靶向药物和免疫疗法的系统评价显示,95%的出版物未描述晚期毒性,94%未报告不良事件的持续时间,而在75%的论文中,毒性列表仅限于最常见的毒性。在线附录的存在将使公布信息不受限制成为可能,从而提高不良事件描述的准确性。

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