All is not well in the world of translational research.
All is not well in the world of translational research.
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转化研究领域的情况并非一帆风顺。
DOI：
10.1016/j.jacc.2007.04.067
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发表时间：
2007
影响因子：
24
通讯作者：
E. Unger
中科院分区：
文献类型：
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作者：
E. Unger
尽管在临床前概念验证研究中取得了非常令人鼓舞的结果，但新的治疗策略在临床试验中失败并不罕见。通常，这种“翻译失败”被归咎于动物模型的预测性差。然而，通常情况下，今天的临床前概念验证研究的预测性不佳与模型的局限性无关，而是与研究者的偏见和缺乏科学严谨性有关。由此产生的假阳性结果只会误导该领域并阻碍医学进步。随着翻译研究的复兴，研究困扰这些研究的一些问题并考虑解决方案是有用的。通过周密的规划、执行和分析，可以从临床前概念验证研究中生成可靠的预测性数据，这些结果将更快地推动医学进步。
It is not unusual for novel treatment strategies to fail in clinical trials, despite highly encouraging results in preclinical proof-of-concept studies. Typically, such “failures of translation” are blamed on the poor predictiveness of animal models. Often, however, the poor predictiveness of today’s preclinical proof-of-concept studies is related not to limitations of the models but to investigator bias and a lack of scientific rigor. The resulting false-positive results only serve to mislead the field and impede medical progress. With the resurgence of translational research, it is useful to examine some of the problems that plague these studies and consider their solutions. With thoughtful planning, execution, and analysis, it is possible to generate reliable and predictive data from preclinical proof-of-concept studies, results that should more rapidly advance medical progress.