Freedman Leonard P, Inglese James
Global Biological Standards Institute, Washington, DC; and
Division of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Bethesda, Maryland.
Cancer Res. 2014 Aug 1;74(15):4024-9. doi: 10.1158/0008-5472.CAN-14-0925. Epub 2014 Jul 17.
Research advances build upon the validity and reproducibility of previously published data and findings. Yet irreproducibility in basic biologic and preclinical research is pervasive in both academic and commercial settings. Lack of reproducibility has led to invalidated research breakthroughs, retracted articles, and aborted clinical trials. Concerns and requirements for transparent, reproducible, and translatable research are accelerated by the rapid growth of "post-publication peer review," open access publishing, and data sharing that facilitate the identification of irreproducible data/studies; they are magnified by the explosion of high-throughput technologies, genomics, and other data-intensive disciplines. Collectively, these changes and challenges are decreasing the effectiveness of traditional research quality mechanisms and are contributing to unacceptable-and unsustainable-levels of irreproducibility. The global oncology and basic biologic research communities can no longer tolerate or afford widespread irreproducible research. This article discusses (i) how irreproducibility in preclinical research can ultimately be traced to an absence of a unifying life science standards framework, and (ii) makes an urgent case for the expanded development and use of consensus-based standards to both enhance reproducibility and drive innovations in cancer research.
研究进展建立在先前发表的数据和研究结果的有效性和可重复性之上。然而,基础生物学和临床前研究中的不可重复性在学术和商业环境中都普遍存在。缺乏可重复性导致了无效的研究突破、撤回的文章以及中止的临床试验。“发表后同行评审”、开放获取出版和数据共享的迅速发展加速了对透明、可重复和可转化研究的关注与要求,这些发展有助于识别不可重复的数据/研究;高通量技术、基因组学和其他数据密集型学科的爆炸式增长进一步放大了这些问题。总体而言,这些变化和挑战正在降低传统研究质量机制的有效性,并导致不可接受且不可持续的不可重复性水平。全球肿瘤学和基础生物学研究界再也无法容忍或承受广泛存在的不可重复研究。本文讨论了(i)临床前研究中的不可重复性最终如何可追溯到缺乏统一的生命科学标准框架,以及(ii)迫切主张扩大基于共识的标准的制定和使用,以提高可重复性并推动癌症研究的创新。