Making preclinical science stronger

WASHINGTON, D.C.—The Global Biological Standards Institute (GBSI) issued its first report on their Reproducibility2020 Challenge at the American Association for the Advancement of Science (AAAS) Annual Meeting in February 2017, with an goal of improving the quality of preclinical biological research within the next few years. “Reproducibility 2020 Report: Progress and Priorities” was a feature of the “Rigor & Reproducibility One Year Later: How Has the Biomedical Community Responded?” session.

GBSI was launched in 2013, with the mission to promote the use of best practices and standards to improve the quality of life-sciences research. GBSI was created to focus on the increasing need to improve the quality and reproducibility of biomedical research through standards and best practices. Triggered by a landmark study by Amgen, the push toward broader reproducibility capacity was seen as essential for clinical research, which does not have an FDA-like regulatory oversight body to set best practice. While regulation is not the answer for bench research to improve, there is a desire to help the process by bringing increased attention to rigor regarding cell lines, reagents, antibodies and study design.

The Amgen study, published in the journal Nature in 2012, indicated that of 53 landmark cancer biology studies at the company, only six of them could be reproduced. This public acknowledgement of what many scientists already knew to be true was the tipping point toward a concerted effort to improve the problem.

“It was like the wild, wild West,” says Dr. Leonard P. Freedman, the president of GBSI. “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. 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.”

As the first comprehensive report tracking progress, actions taken by stakeholders in better-quality research and steps moving forward, “Reproducibility 2020” offers concrete strategies and recommendations for stakeholders. 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 programs 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.

“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.”

While Freedman acknowledges that quantifiable change will take a long time, he believes that the increased interest by funders, the launch of the Reproducibility Initiative by the Center for Open Science and the issuance of “New Guidelines for Rigor” for applicants and reviewers by the National Institutes of Health indicate a concerted effort to find and promote solutions.

Efforts are underway to implement stiffer standards abroad as well. New initiatives are happening in the United Kingdom through the Medical Research Council, and funding has been allocated by the Finnish and Dutch governments. “We would like to expand our advocacy internationally and honor the ‘global’ in our name,” comments Freedman. “Asia, in particular China and India, are ramping up their biomedical research enterprises, and it will be important to apply our guidelines and recommendations there eventually.”

Nonprofit GBSI was founded by American Type Culture Collection (ATCC), a biological standards organization with one of the largest repositories of cell lines and microbes in the world. GBSI’s work is currently primarily funded by the BioNexus Foundation, also established by ATCC, and augmented by other grants and donations.