WASHINGTON, Nov. 14, 2014 /PRNewswire/ -- The Global Biological Standards Institute (GBSI) yesterday hosted its inaugural BioPolicy Summit (www.gbsi.org/2014BioPolicySummit), convening life science thought leaders from academia, industry, government and journal publishing to address irreproducibility. In particular, the Summit explored the transformative impact that cell authentication has on improving research fidelity and overall reproducibility of research studies, particularly in cancer research. Through insightful and productive discussions, best practices and key standards were identified to accelerate the discovery of life-saving therapies and cures through improved translation of preclinical research using authenticated cancer cell lines.
"Irreproducibility is most often the result of unintentional cumulative errors or flaws in the research process, including reference materials, study design, laboratory protocols, data analysis and reporting," said Leonard P. Freedman, PhD, president of GBSI. "In cancer research, misidentified cell lines isolated from various human cancers is often a big problem. Fortunately, this issue can be remediated by introducing standards, such as the short-tandem repeat (STR) analysis, to authenticate cell lines."
Cell lines have been used for decades in multiple areas of biomedical research, and misidentification of cell lines has been an historic and pervasive issue, resulting in multiple failed clinical trials and substantial delays in therapeutic drug development in areas of unmet need. The prevalence of contaminated cancer cell line usage is well-documented. One well-known case is that of adriamycin-resistant breast adenocarcinoma cell lines, or MCF-7/AdrR, where more than 300 studies used this misidentified cell line before they were found to be derived from human ovarian carcinoma cells.
"The current standard for cell authentication, STR analysis, is unknown to many investigators, ignored by others," said Keith Yamamoto, PhD, vice chancellor for Research, University of California, San Francisco, executive vice dean, UCSF School of Medicine, and the keynote speaker at GBSI's BioPolicy Summit. "Embracing this standard, or refinements that may follow, will require a global cultural shift by all stakeholders—researchers, publishers, funders and regulators—but failure to do so puts our endeavor at risk."
A recent Nature Cell Biology editorial reported that only 19 percent of papers using cell lines and published between August and December 2013 conducted cell line authentication. "To address this, we have established reporting guidelines," said Veronique Kiermer, PhD, executive editor, Nature Publishing Group. "We are also trying to improve this issue through outreach and education."
"The life science community must embrace the use of standards to improve the credibility, reproducibility, and translatability of preclinical research using cancer cell lines," said Howard Soule, PhD, chief science officer, Prostate Cancer Foundation and senior fellow, Milken Institute. "At the Foundation, we are ensuring enhanced scientific fidelity by requiring that all funded researchers use the authenticated cells they are given at the beginning of research, and we annually send samples to an independent lab for STR and PCR analysis."
Companies, such as Genentech, recognize that a small investment in cell lines upfront could result in cost savings and improved reproducibility downstream. Genentech has built a centralized cell bank to deliver quality cell lines for research. These regularly undergo analysis as a means of ensuring cell authentication. The National Institutes of Health (NIH) is considering requiring applicants to address the origin of cell lines. In addition, NIH is identifying and funding research technology to more easily authenticate cell lines, and finding ways to deal with reagent infection issues.
From the Summit discussions, it was agreed there must be a committed stance to ensure cell line authentication, and a greater effort to change the current research culture through education, outreach and support. The following recommendations of the GBSI Cancer Cell Authentication and Standards Task Force were considered as areas where greater effort is needed to more effectively address irreproducibility and misidentified cell lines:
1. Change the Culture: Practices of the research community should embrace the importance of cell authentication.
2. Use Standards and Best Practices: Documented authentic, contaminant-free cell lines should be used in research.
3. Establish Dedicated Funding: Research grants should include the costs to address cell authentication.
4. Authenticate to Publish: Journals should require documentation of cell authentication.
5. Commit to Train: Graduate students and postdoctoral fellows should receive more information on the importance of cell authentication.
6. Invest in New Technologies: There should be greater investment in the development of novel tools for cell authentication.
"While the culture shift necessary to embrace cell authentication will take time, the practice is relatively easily implemented and tremendously impactful among the many solutions to the complex and interwoven root causes of irreproducibility that must be addressed," said Freedman. "By taking action now, life science research will undergo a transformative, beneficial change. Reproducibility of life science research will improve, and drug discovery of life-saving therapies for patients will be accelerated."
About Global Biological Standards Institute
GBSI, a non-profit organization, is 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. Key policy recommendations from GBSI's Cancer Cell Authentication and Standards Task Force will be shared at the Summit. For more information, visit www.gbsi.org.
Follow GBSI on Twitter @GBSIorg and join the conversation at #BioPolicy14.
SOURCE Global Biological Standards Institute