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临床肿瘤学研究;当代方法学标准述评。

Clinical oncology research; Review on contemporary methodology standards.

机构信息

King Fahd Hospital, Ministry of Health, Riyadh, Kingdom of Saudi Arabia.

Mazahmiya General Hospital, Ministry of Health, Riyadh, Kingdom of Saudi Arabia.

出版信息

Curr Probl Cancer. 2021 Oct;45(5):100725. doi: 10.1016/j.currproblcancer.2021.100725. Epub 2021 Mar 6.

DOI:10.1016/j.currproblcancer.2021.100725
PMID:33715867
Abstract

Evaluation of novel treatments through clinical trials remains the backbone of oncological clinical research, but only a minor portion have been tested in Phase III trials. The continued publication of underpowered trials provides an ongoing need for meta-analyses to detect clinically significant outcomes. Although tumor relapse and survival are important issues and easily measured outcomes in trials, they are often not the most relevant indicators for treatment success. As diagnostic technologies and treatments continue to advance, methodologies defining high quality studies have been established, but still enthusiasm to adopt novel technologies that leads to studies holding well-described bias that do not aid the rational use of the studied test. Global awareness of such bias and standard research methodology is the clue toward iconic studies giving rational supporting novel cancer treatments and patients' support.

摘要

通过临床试验评估新疗法仍然是肿瘤临床研究的核心,但只有一小部分新疗法在 III 期临床试验中得到了检验。由于低效能试验的持续发表,因此仍然需要进行荟萃分析以检测具有临床意义的结局。虽然肿瘤复发和生存是重要的问题,也是试验中易于测量的结局,但它们通常不是治疗成功的最相关指标。随着诊断技术和治疗方法的不断进步,已经建立了定义高质量研究的方法学,但人们仍然热衷于采用新的技术,这些技术导致研究存在描述不佳的偏倚,而这些偏倚无助于合理使用所研究的检测方法。对这种偏倚和标准研究方法的全球认识是实现标志性研究的关键,这些研究为新的癌症治疗方法和患者支持提供了合理的依据。

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