The United States loses $28 billion on irreproducible pre-clinical research every year. Leonard Freedman, Iain Cockburn, and Timothy Simcoe tabulate this figure in their recent PLOS Biology article (http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002165). They also offer solutions to the problem of irreproducibility in the pre-clinical and life sciences, an issue addressed by the National Institutes of Health (NIH) in 2012 with their Reproducibility Initiative and commented on by microbiologists Arturo Casadevall and Ferric Fang in Infection and Immunity (http://iai.asm.org/content/80/3/897.full and http://iai.asm.org/content/80/3/891.full).
Freedman contends that roughly 50% of pre-clinical research conducted annually in the U.S. is irreproducible, costing around $28 billion, half of the total $56.4 billion spent on pre-clinical research. He defines irreproducibility as "the existence and propagation of one or more errors, flaws, inadequacies, or omissions that prevent replication of results." Freedman also identifies four primary causes of irreproducibility: 1) study design, 2) biological reagents and reference materials, 3) laboratory protocols, and 4) data analysis and reporting.
He suggests the solution lies in a standard of best practices similar to those developed for the Internet by the World Wide Web Consortium (W3C) and the Internet Engineering Task Force (IETF). Specifically, Freedman suggests applying such standards to the problem of misidentified cancer cell lines. The NIH funds roughly $3.7 billion in research annually using cell lines, and Freedman estimates roughly a quarter of this work is irreproducible due to contaminated or misidentified lines. What's more, Freedman's organization, the Global Biological Standards Institute, has already launched a campaign aimed at authenticating cell lines (http://www.gbsi.org/work/authenticate/).
Too melodramatic? Critics think so. Stefano Bertuzzi, executive director of the American Society for Cell Biology, posted a rebuttal on the society's blog (http://ascb.org/imaginary-numbers-and-the-real-irreproducibility-crisis-in-preclinical-research/), and according to Ferric Fang, "to suggest that 50% of research dollars are being wasted is ridiculous and unhelpful" (Science Insider).
(Sources: PLOS Biology, www.the-scientist.com, Infection and Immunity, www.news.sciencemag.org, www.gbsi.org, www.ascb.org)
