Advances in life science research, including the development of life-saving therapies and cures, build upon the reproducibility and translation of previously published data and findings. In simplest terms, reproducibility means that an experiment should be able to be reproduced by an independent lab with results that broadly support the conclusions of the original scientist(s).
By 2013, irreproducibility in basic and preclinical biological research had been identified as a pervasive, expensive, and increasingly well recognized problem, contributing to both delays and costs of therapeutic drug development.
The stage was set for a community-wide effort to tackle the problem of irreproducibility by developing a framework of unifying standards, requiring community consensus and alignment around both the necessity for standards and their content.
This issue was first highlighted in 2005, by John Ioannidis, a professor at Stanford Medical School in an essay entitled, “Why Most Published Research Findings are False.”
Then, in 2011, scientists from Bayer Healthcare reported that a large number of academic research findings could not be reproduced by industry.
This fact was confirmed and extended a year later in a seminal publication in Nature by C. Glenn Begley and Lee M. Ellis about their work at Amgen.
"Reproducibility is the foundation of life sciences research and yet far too often the inability to reproduce experimental data has resulted in the invalidation of research breakthroughs, retraction of published papers, and abrupt discontinuation of studies. The global community can no longer afford the economic and intellectual drain, reduced trust in the research enterprise, and lost opportunities to expedite discovery of cures and enhance global health.”
By the end of 2013, GBSI had published findings from the first comprehensive report on the state of life sciences research quality. The report, “The Case for Standards in Life Sciences Research: Seizing Opportunities at a Time of Critical Need," assessed the quality of research and development methodologies, identified areas of concern, and established recommendations for meaningful change.