The Global Biological Standards Institute (GBSI) has presented findings from the first comprehensive report on the state of life science research quality. GBSI commissioned the report to assess the quality of R&D methodologies, identify areas of concern and establish recommendations for meaningful change.

The report, The Case for Standards in Life Science Research: Seizing Opportunities at a Time of Critical Need, addresses the rising concerns associated with irreproducibility of research findings and lays the foundation for a call to action.

"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," said Leonard Freedman, Ph.D., president of GBSI. "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 commissioned a third-party organization to interview almost 60 stakeholders across the life science community in 2013. The case integrates the findings of these interviews, an extensive review of the literature and other sources, including government agencies and the pharmaceutical industry. One of the key findings is that irreproducibility is a pervasive, systemic problem across research settings and profoundly affects the entire community, from bench scientists to patients.

"Addressing this critical issue must be a top priority for the research community," said C. Glenn Begley, MB, BS, Ph.D., chief science officer and senior vice president, TetraLogic Pharmaceuticals. "This is not an easy task, but we need to remember that 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."

The case identified a variety of factors that contribute to life science research irreproducibility, but overall, most can be traced to the absence of a unifying standards framework. The concept of standards is not new and has been the foundation of progress in science and technology from Wi-Fi to building bridges. Unlike other fields of endeavor, however, life science research has very few broadly implemented standards.

"All stakeholders interviewed for the case agreed that there is a need for more standards in life science research, and this need has become more urgent as biology enters a new realm of complexity and multidisciplinary approaches to 'omics'," said Freedman. "The environment also is extremely competitive, with a strong drive to translate discoveries into clinical applications, and to do so in a cost-effective way."

GBSI is 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. These efforts will engage and mobilize all stakeholders across the life sciences.