title: The increasing urgency for standards in basic biologic research.
abstract: 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.
authors.affiliation: Global Biological Standards Institute, Washington, DC; and lfreedman@gbsi.org.
authors.forename: Leonard P
authors.initials: LP
authors.lastname: Freedman
authors.affiliation: Division of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Bethesda, Maryland.
authors.forename: James
authors.initials: J
authors.lastname: Inglese
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*