Freedman Leonard P, Venugopalan Gautham, Wisman Rosann
Global Biological Standards Institute, Washington, DC, 20036, USA.
Gryphon Scientific, LLC, Takoma Park, MD, 20912, USA.
F1000Res. 2017 May 2;6:604. doi: 10.12688/f1000research.11334.1. eCollection 2017.
The preclinical research process is a cycle of idea generation, experimentation, and reporting of results. The biomedical research community relies on the reproducibility of published discoveries to create new lines of research and to translate research findings into therapeutic applications. Since 2012, when scientists from Amgen reported that they were able to reproduce only 6 of 53 "landmark" preclinical studies, the biomedical research community began discussing the scale of the reproducibility problem and developing initiatives to address critical challenges. Global Biological Standards Institute (GBSI) released the "Case for Standards" in 2013, one of the first comprehensive reports to address the rising concern of irreproducible biomedical research. Further attention was drawn to issues that limit scientific self-correction, including reporting and publication bias, underpowered studies, lack of open access to methods and data, and lack of clearly defined standards and guidelines in areas such as reagent validation. To evaluate the progress made towards reproducibility since 2013, GBSI identified and examined initiatives designed to advance quality and reproducibility. Through this process, we identified key roles for funders, journals, researchers and other stakeholders and recommended actions for future progress. This paper describes our findings and conclusions.
临床前研究过程是一个想法产生、实验以及结果报告的循环。生物医学研究界依赖已发表发现的可重复性来开展新的研究方向,并将研究成果转化为治疗应用。自2012年安进公司的科学家报告称他们只能重复53项“里程碑式”临床前研究中的6项以来,生物医学研究界开始讨论可重复性问题的规模,并制定应对关键挑战的举措。全球生物标准协会(GBSI)在2013年发布了《标准的重要性》,这是首批全面探讨生物医学研究不可重复性这一日益受到关注问题的报告之一。人们进一步关注到限制科学自我修正的问题,包括报告和发表偏倚、研究力度不足、方法和数据缺乏开放获取,以及试剂验证等领域缺乏明确界定的标准和指南。为评估自2013年以来在可重复性方面取得的进展,GBSI识别并审查了旨在提高质量和可重复性的举措。通过这一过程,我们确定了资助者、期刊、研究人员和其他利益相关者的关键作用,并为未来的进展推荐了行动方案。本文描述了我们的发现和结论。