United we stand; divided we fall

WASHINGTON, D.C.—A genetics firm offers affordable genomic sequencing to the public, yet studies are inconsistently analyzed, casting doubt on the results. Not too far away, a research laboratory reports that certain antibodies show promise in treating an infectious disease, but a public health lab using the same antibodies in a different assay does not.

These very real scenarios illustrate how a lack of unifying standards can result in research being invalidated, published papers retracted, fundraising research money lost and resources wasted.

You don’t want to toss the baby out with the bath water, but what is a researcher to do?

The Global Biological Standards Institute (GBSI) has recently issued guidelines for solving this “critical challenge of irreproducibility in life-science research,” says Leonard Freedman, president of the GBSI. “While the causes of irreproducibility are multifactorial and complex, many of them can be traced to the absence of a unifying standards framework.”

Reproducibility is the “foundation of life-science research, and yet far too often, the inability to reproduce experimental data has resulted in the invalidation of research breakthroughs, retraction of published papers and abrupt discontinuation of studies,” Freedman stated in a news release. “The global community can no longer afford the economic and intellectual drain, reduced trust in the research enterprise and lost opportunities to expedite discovery of cures.”

Freedman tells DDNews, “Standards are a part of every industry from cell phones to railway tracks. And standards are not new to the biological sciences. However, the life-science community’s development and adoption of standards has not kept pace with the advances in biotechnology. It is urgent that the life-science community work together to develop and adopt standards to further accelerate the discovery of cures and prevention for human health.”

Founded in 2012, GBSI states that its mission “responds to the pace of advances that are driving innovation in biotechnology,” and Freedman says that “These innovations have fueled the explosive growth of bioinformatics, genomics and other emerging ‘omics that are transforming translational research and healthcare.”

But at the same time, these advances also “drive the need for greater standards as a way to promote cost-effectiveness, quality and reproducibility in life sciences and accelerate the development of preventions and cures,” he says.

“Competition for research funding is fiercer than ever, and there is concern among fundraisers and academia that investment in standards and adherence to standards will stretch limited dollars even further,” Freedman notes. “In addition, often a discussion of standards among academics generates concerns about the constraining of scientific freedom and creativity.”

Recognizing the “urgent need” to get it right, GBSI recently joined hands with the National Institutes of Health and prestigious journals to plan a larger, collaborative effort that mobilizes all stakeholders across the life sciences to advance the development and adoption of standards.

GBSI commissioned a study prepared by independent consultants Health Advances and Feinstein Kean Healthcare to present the latest findings on irreproducibility obtained from almost 60 interviews with stakeholders throughout the life-science community, and GBSI’s recommendations for meaningful change.

“Through the release of our white paper, ‘The Case,’ the pervasiveness of the problem has been highlighted in a powerful way,” Freedman says. “GBSI is using this report as part of our strategy to engage stakeholders to take action and adopt policies and procedures that will advance the development and adoption of standards.”

“While 60 interviewees (representing a broad swath of the stakeholders) for ‘The Case’ said more standards were needed, to date there is little evidence of a real concerted action,” Freedman noted Jan. 14. “The global community can no longer afford the economic and intellectual drain, reduced trust in the research enterprise and lost opportunities to expedite discovery of cures and enhance global health.”

GBSI is currently working on a number of levels to get the job done, he said.

“Broadly, we are advancing policies among key stakeholder groups—academia, pharma, leading publishing journals and funders—to ensure greater development of and adherence to standards,” Freedman says. “In specific research areas, we are working to identify where standards are needed. Our initial areas of focus are antibodies and cancer cell authentication.”

Some of GBSI’s priority activities for the coming months include working with its scientific advisory council and task forces to address specific research areas, according to Freedman.

This includes launching task forces to “promote the development and implementation of standards for antibodies and cancer cell authentication, commissioning a series of white papers—the first on the economics of standards—and sponsoring an annual conference to spotlight the need for biological standards,” Freedman says.

“The stakes are high,” he notes. “Reproducibility of life-science research and expediting discoveries for prevention and cures will ultimately save lives.”

GBSI is also coordinating a global effort to increase the level of credible, replicable and translatable results in life-science research by driving the expanded development and adoption of standards through policy initiatives, thought leadership and education, according to Freedman, who adds that “These efforts will engage and mobilize all stakeholders across the life sciences.”

Establishing greater standards around research in the life sciences is “not an easy task, but we can do it,” he says. “Improving the reliability of research means greater advances in prevention and cures. Improving systems, including development of standards, will help patients and ultimately save lives.”