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Assessing the Completeness of Reporting in Preclinical Oncolytic Virus Therapy Studies
Molecular Therapy: Oncology ( IF 5.3 ) Pub Date : 2019-05-21 , DOI: 10.1016/j.omto.2019.05.004
Dean A. Fergusson , Neil L. Wesch , Garvin J. Leung , Jenna L. MacNeil , Isidora Conic , Justin Presseau , Kelly D. Cobey , Jean-Simon Diallo , Rebecca Auer , Jonathan Kimmelman , Natasha Kekre , Nader El-Sayes , Ramya Krishnan , Brian A. Keller , Carolina Ilkow , Manoj M. Lalu

Irreproducibility of preclinical findings could be a significant barrier to the “bench-to-bedside” development of oncolytic viruses (OVs). A contributing factor is the incomplete and non-transparent reporting of study methodology and design. Using the NIH Principles and Guidelines for Reporting Preclinical Research, a core set of seven recommendations, we evaluated the completeness of reporting of preclinical OV studies. We also developed an evidence map identifying the current trends in OV research. A systematic search of MEDLINE and Embase identified all relevant articles published over an 18 month period. We screened 1,554 articles, and 236 met our a priori-defined inclusion criteria. Adenovirus (43%) was the most commonly used viral platform. Frequently investigated cancers included colorectal (14%), skin (12%), and breast (11%). Xenograft implantation (61%) in mice (96%) was the most common animal model. The use of preclinical reporting guidelines was listed in 0.4% of articles. Biological and technical replicates were completely reported in 1% of studies, statistics in 49%, randomization in 1%, blinding in 2%, sample size estimation in 0%, and inclusion/exclusion criteria in 0%. Overall, completeness of reporting in the preclinical OV therapy literature is poor. This may hinder efforts to interpret, replicate, and ultimately translate promising preclinical OV findings.



中文翻译:

评估临床前溶瘤病毒治疗研究报告的完整性

临床前发现的不可重复性可能是溶瘤病毒(OVs)“从台到床”发展的重要障碍。一个影响因素是研究方法和设计的报告不完整和不透明。使用NIH报告临床前研究的原则和指南(七项建议的核心集),我们评估了临床前OV研究报告的完整性。我们还开发了一个证据图,确定了OV研究的当前趋势。系统搜索MEDLINE和Embase可以确定18个月内发表的所有相关文章。我们筛选了1,554篇文章,其中236篇符合我们的先验知识定义的纳入标准。腺病毒(43%)是最常用的病毒平台。经常调查的癌症包括结直肠癌(14%),皮肤癌(12%)和乳腺癌(11%)。最常见的动物模型是小鼠(96%)中的异种移植(61%)。0.4%的文章列出了临床前报告指南的使用。在1%的研究中完全报告了生物学和技术重复,在统计中报告了49%,在随机试验中报告了1%,在盲法中报告了2%,在样本量估计中在0%,并且包含/排除标准在0%。总体而言,临床前OV治疗文献报道的完整性很差。这可能会阻碍解释,复制和最终翻译有希望的临床前OV发现的努力。

更新日期:2019-05-21
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