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New Study Addresses ‘$28 Billion Problem’ of Research Fidelity
Applied Clinical Trials
In the U.S. alone, around $28 billion a year is spent on preclinical research that is not reproducible, and low reproducibility rates contribute to both delays and costs of therapeutic drug development.
In the U.S. alone, around $28 billion a year is spent on preclinical research that is not reproducible, and low reproducibility rates contribute to both delays and costs of therapeutic drug development, according to a study published on June 9th, 2015 in the PLOS Biology journal by the Global Biological Standards Institute (GBSI) and two economists.
Analysis of past life science research studies indicates that the cumulative prevalence of irreproducible preclinical research exceeds 50%, and action is now required, noted the three authors, Drs. Leonard P. Freedman, Iain M. Cockburn and Timothy S. Simcoe.
"To achieve greatest levels of reproducibility, The Economics of Reproducibility in Preclinical Research offers tangible solutions - providing guidelines for advancing education and training and applying best practices in life science research. The valuable time, money and resources saved will mean finding faster treatments and cures," stated Freedman, who is president of GBSI.
Reviewing publicly available data from government sources, industry and analyst reports and scientific articles, the authors conducted an in-depth analysis of the key components of irreproducibility and used secondary research to benchmark the potential impact of improved standards. They think the causes of irreproducible research can be grouped into four categories: biological reagents and reference materials, study design, data analysis and reporting, and laboratory protocols. Of these, errors in biological reagents and materials (36% of total) and study design (28% of total) are the two largest factors.
By categorizing the root causes of irreproducibility and estimating their relative importance, it is possible to prioritize potential solutions, and ultimately, increase the overall return on public and private investments in research and development, they explained.
"Improving reproducibility levels will require a measured investment in time and resources," noted Cockburn. "We recommend investing in practical solutions and taking immediate steps in the areas where there will be the greatest return on investment."