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Reporting of preclinical tumor-graft cancer therapeutic studies

机译:临床前肿瘤移植癌治疗研究报告

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摘要

Purpose: Characterize the parameters of reporting tumor-graft experiments for oncologic drug development.Experimental Design: Using Institute of Scientific Information impact factors, we identified the most-cited medical and oncology journals with tumor-graft experiments in murine models. For each article, the characteristics of the experimental design, outcome measurements, and statistical analysis were examined.Results: We examined 145 articles describing tumor-graft experiments from October through December 2008. The articles spanned a range of disease types, animal models, treatments and delivery methods. One hundred (69%) articles were missing information needed to replicate the experiments. Outcome measurements included: tumor size (83%), biological changes (57%), and survival or cure-rate outcomes (28%). Thirty-three percent did not specify how tumor size was measured and 30% were missing the formula for evaluating volume. Only 14% utilized appropriate statistical methods. Ninety-one percent of studies were reported as positive and 7% reported with mixed positive-negative results; only 2% of studies were reported negative or inconclusive. Twenty-two articles from 2012 showed improvement in the utilization of statistical methods (35% optimal, p = 0.05) but had a similar fraction with experimental design issues (82%; p = 0.32) limiting reproducibility and 91% had positive results.Conclusions: Tumor-graft studies are reported without a set standard, often without the methodological information necessary to reproduce the experiments. The high percentage of positive trials suggests possible publication bias. Considering the widespread use of such experiments for oncologic drug development, scientists and publishers should develop experimental and publication guidelines for such experiments to ensure continued improvements in reporting.
机译:目的:表征用于肿瘤药物开发的报告肿瘤移植物实验的参数。实验设计:利用科学信息研究所的影响因素,我们在鼠模型中鉴定了肿瘤移植物实验被引用最多的医学和肿瘤学期刊。结果:我们审查了145篇描述从2008年10月至2008年12月的肿瘤移植实验的文章。这些文章涵盖了各种疾病类型,动物模型,治疗方法和投放方式。一百(69%)篇文章缺少重复实验所需的信息。结果测量包括:肿瘤大小(83%),生物学变化(57%)以及生存率或治愈率(28%)。 33%的受访者未说明如何测量肿瘤大小,而30%的受访者未提供评估体积的公式。只有14%使用了适当的统计方法。有91%的研究报告为阳性,有7%的报告为阳性-阴性。仅2%的研究报告为阴性或无结论。 2012年发表的22篇文章显示统计学方法的利用率有所提高(最佳35%,p = 0.05),但与实验设计问题相似的分数(82%; p = 0.32)限制了再现性,而91%的结果令人满意。 :报告的移植瘤研究没有设定标准,通常没有重现实验所需的方法学信息。阳性试验的高百分比表明可能存在出版偏倚。考虑到此类实验广泛用于肿瘤药物开发,科学家和出版商应制定此类实验的实验和出版指南,以确保报告的持续改进。

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