Global Biological Standards Institute

Washington, Washington, United States

Global Biological Standards Institute

Washington, Washington, United States
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Freedman L.P.,Global Biological Standards Institute | Venugopalan G.,Gryphon Scientific, Llc | Wisman R.,Global Biological Standards Institute
F1000Research | Year: 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. © 2017 Freedman LP et al.


News Article | February 19, 2017
Site: www.eurekalert.org

WASHINGTON, D.C., Feb. 19, 2017 - One year after the Global Biological Standards Institute (GBSI) issued its Reproducibility2020 challenge and action plan for the biomedical research community, the organization reports encouraging progress toward the goal to significantly improve the quality of preclinical biological research by year 2020. "Reproducibility2020 Report: Progress and Priorities," posted today on bioRxiv, identifies action and impact that has been achieved by the life science research community and outlines priorities going forward. The report is the first comprehensive review of the steps being taken to improve reproducibility since the issue became more widely known in 2012. "By far the greatest progress over these few years has been in stakeholders recognizing the severity of the problem and the importance of taking active steps for improvement," said Leonard P. Freedman, PhD, president of GBSI. "Every stakeholder group is now addressing the issues, including journals, NIH, private funders, academicians and industry. That's crucial because there is not one simple fix--it is a community-wide problem and a community-wide effort to achieve solutions." The report addresses progress in four major components of the research process: study design and data analysis, reagents and reference materials, laboratory protocols, and reporting and review. Moreover, it identifies the following broad strategies as integral to the continued improvement of reproducibility in biomedical research: 1) drive quality and ensure greater accountability through strengthened journal and funder policies; 2) create high quality online training and proficiency testing and make them widely accessible; 3) engage the research community in establishing community-accepted standards and guidelines in specific scientific areas; and 4) enhance open access to data and methodologies. Research community stakeholders have responded with innovation and policy. The community is taking more steps to work together and to tackle the complexities of the reproducibility problem. The report highlights tangible examples of community-led actions from implementing new funding guidelines and accountability to tackling industry-wide research standards and incentives for compliance. The lessons learned from these early efforts will assist all stakeholders seeking to scale up or replicate successful initiatives. "We are confident that continued transparent, global, multi-stakeholder engagement is the way forward to better, more impactful science," says Freedman. "We are calling on all stakeholders - individuals and organizations alike - to take action to improve reproducibility in the preclinical life sciences by joining an existing effort, replicating successful policies and practices, providing resources to replication efforts and taking on new opportunities." The report contains specific actions that each stakeholder group can take to enhance reproducibility. In its leadership role, GBSI will: Freedman introduced the new report at the AAAS 2017 Annual Meeting today during the session, "Rigor and Reproducibility One Year Later: How Has the Biomedical Community Responded?," hosted by GBSI. Freedman was joined by panelists Michael S. Lauer, M.D. of NIH; William G. Kaelin Jr., M.D. of the Dana-Farber Cancer Institute; and Judith Kimble University of Wisconsin-Madison. "The research culture, particularly at academic institutions, must also seek greater balance between the pressures of career advancement and advancing rigorous research through standards and best practices," said Freedman, noting a major challenge still facing the community. "Additional leadership and community-wide support will be needed and we believe that the many initiatives described in this report add needed momentum to this emerging culture shift in science. "The preclinical research community is full of talented, motivated people who care deeply about producing high-quality science. We are optimistic about the potential to improve reproducibility, and look forward to continuing to contribute to the effort." GBSI is an independent non-profit organization dedicated to enhancing the quality of biomedical research by advocating best practices and standards to accelerate the translation of research breakthroughs into life-saving therapies. GBSI was founded by ATCC. For more information, visit GBSI.org and Twitter @GBSIorg.


PubMed | American Association for Cancer Research, University of Oslo, Global Biological Standards Institute, Los Alamos National Laboratory and 3 more.
Type: Journal Article | Journal: BioTechniques | Year: 2016

Address correspondence to Leonard P. Freedman, Global Biological Standards Institute, 1020 19th Street, NW, Suite 550, Washington, DC, 20036. E-mail: lfreedman@gbsi.org.


Freedman L.P.,Global Biological Standards Institute | Gibson M.C.,Global Biological Standards Institute | Ethier S.P.,Medical University of South Carolina | Soule H.R.,Milken Institute | And 2 more authors.
Nature Methods | Year: 2015

Quality control of cell lines used in biomedical research is essential to ensure reproducibility. Although cell line authentication has been widely recommended for many years, misidentification, including crosscontamination, remains a serious problem. We outline a multi-stakeholder, incremental approach and policy-related recommendations to facilitate change in the culture of cell line authentication.


News Article | September 7, 2016
Site: www.nature.com

Biomedical scientists are often urged to check that their cell lines are not contaminated or mislabelled. But as a new study shows, any effort to authenticate a cell line is only as good as the reference standard against which the cells are compared. A cell line that is widely used to study brain cancer does not match the cells used to create the line nearly 50 years ago, or the tumour purported to be its source, researchers report on 31 August in Science Translational Medicine1. In fact, no one is quite sure of the true provenance of the cell line distributed by most cell repositories. “It is a good cautionary tale to say, ‘Question your assumptions and do as many appropriate controls as you can to make sure you really have what you think you have,’” says Jon Lorsch, director of the US National Institute of General Medical Sciences in Bethesda, Maryland. And because few cell lines are ever verified against their primary-source material, “this paper is probably just the tip of the iceberg”, says Christopher Korch, a geneticist at the University of Colorado Denver. Many groups are trying to tackle the problem of misidentified cell lines to improve the reproducibility of research findings. This year, the US National Institutes of Health started requiring grant applicants to describe how they will authenticate their cell lines. And journals such as Nature have recently begun to ask authors to check their cells against a database of 475 lines (and counting) that are known to be mixed up. But no organizations have called for the kind of archival sleuthing that produced the new study. “It’s hard enough to get people to do the standard authentication,” says Leonard Freedman, president of the Global Biological Standards Institute, a non-profit organization in Washington DC that has found that most life scientists never authenticate their cells2. “This is much more elaborate.” The cell line in question, U87, was established in 1966 at Uppsala University in Sweden, using tissue from a 44-year-old woman with an aggressive brain cancer known as glioblastoma. U87 has since become a workhorse of brain-cancer research, subject to countless investigations that have yielded around 2,000 scientific papers. The enthusiasm for U87 initially puzzled Bengt Westermark, a tumour biologist at Uppsala. “I couldn’t understand why people would work with such boring cells,” he says. As a graduate student in the 1970s, Westermark studied eight different brain-cancer cell lines. U87 was “hopeless to work with”, he says, because it grew so much more slowly than the others. Years later, Westermark got his hands on the version of U87 that is distributed by the American Type Culture Collection (ATCC), a cell repository in Manassas, Virginia, that houses the world’s largest collection of biological materials. He could see from the cells’ growth properties that this U87 was clearly different from the cells that had given him so much grief in graduate school. Westermark decided to do a formal comparison. Fortunately, Uppsala still had the preserved tumour tissue that spawned the original cell line. This enabled Westermark’s team to verify the identity of the archival U87 sample in their freezer. The researchers then used DNA-fingerprinting techniques to show that the ATCC’s U87 was different — and that it didn’t match any other cell lines created at Uppsala, either. According to Mindy Goldsborough, ATCC’s chief science and technology officer, the repository acquired its U87 line in 1982 from the Memorial Sloan KetteringCancer Center in New York City, which itself had received the cell line from Uppsala in 1973. And by the time it arrived at the ATCC, U87 had a Y chromosome — despite the fact that it was supposed to have come from a female patient. This suggests that the mix-up probably happened at Sloan Kettering or during one of the hand-offs. In light of the new revelations, the ATCC now plans to update the background details in its listing for U87, which it describes as male. But the origin of the U87 line remains a mystery. A comparison of gene-expression profiles conducted by Westermark's team suggests that the ATCC cell line probably came from a brain tumour. “It’s bad news that it’s not what it should be,” Westermark says, “but it’s good news that it’s probably a glioblastoma.” This means that studies of U87 still reflect brain-cancer biology and don’t need to be tossed out, he adds. Still, many cancer researchers think that it is time to move beyond U87 and other “classical” cell lines — regardless of where they came from — because the culture conditions historically used to grow the cells change their biological nature. Westermark and others now favour newer cell lines that have been propagated on the types of growth medium that ensure genetic and epigenetic stability. Through its Human Glioma Cell Culture biobank, Uppsala provides these sorts of cells to other researchers for a small processing fee. “There is an increasing understanding that what we’ve historically used is so poorly representative of the human disease,” says Howard Fine, a neuro-oncologist at the Weill Cornell Brain Tumor Center in New York City. “So, any time someone can shoot down the [U87] cell line, I’m happy.”


News Article | February 19, 2017
Site: www.sciencenewsdaily.org

One year after the Global Biological Standards Institute (GBSI) issued its Reproducibility2020 challenge and action plan for the biomedical research community, the organization reports encouraging progress toward the goal to significantly improve the quality of preclinical biological research by year 2020. "Reproducibility2020 Report: Progress and Priorities," posted today on bioRxiv, identifies action and impact that has been achieved by the life science research community and outlines priorities going forward. The report is the first comprehensive review of the steps being taken to improve reproducibility since the issue became more widely known in 2012. One year after the Global Biological Standards Institute (GBSI) issued its Reproducibility2020 challenge and action plan for the biomedical research community, the organization reports encouraging ... GBSI Report Shows Encouraging Progress Towards Addressing Reproducibility to Significantly Improve Quality of Preclinical Biological Research by Year 2020, Sun 19 Feb 17 from Newswise GBSI reports encouraging progress toward improved research reproducibility by year 2020, Sun 19 Feb 17 from Eurekalert


Freedman L.P.,Global Biological Standards Institute | Inglese J.,U.S. National Institutes of Health
Cancer Research | Year: 2014

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. © 2014 American Association for Cancer Research.


Freedman L.P.,Global Biological Standards Institute | Cockburn I.M.,Boston University | Simcoe T.S.,Boston University
PLoS Biology | Year: 2015

Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US $28B)/year spent on preclinical research that is not reproducible—in the United States alone.We outline a framework for solutions and a plan for long-term improvements in reproducibility rates that will help to accelerate the discovery of life-saving therapies and cures. © 2015 Freedman et al.


Freedman L.P.,Global Biological Standards Institute | Gibson M.C.,Global Biological Standards Institute
Clinical Pharmacology and Therapeutics | Year: 2015

The development of novel therapeutics depends and builds upon the validity and reproducibility of previously published data and findings. Yet irreproducibility is pervasive in preclinical life science research and can be traced to cumulative errors or flaws in several areas, including reference materials, study design, laboratory protocols, and data collection and analysis. The expanded development and use of consensus-based standards and well-documented best practices is needed to both enhance reproducibility and drive therapeutic innovations.


News Article | February 23, 2017
Site: www.sciencedaily.com

One year after Global Biological Standards Institute issued its Reproducibility2020 challenge and action plan for the biomedical research community, the organization reports encouraging progress toward the goal to significantly improve the quality of preclinical biological research by year 2020. The Report is the first comprehensive review of community-led action and impact to improve life sciences research reproducibility since the issue became more widely known in 2012, and it outlines priorities going forward.

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