The Economics of Reproducibility in Preclinical Research

Abstract

Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible—in the United States alone. We outline a framework for solutions and a plan for long-term improvements in reproducibility rates that will help to accelerate the discovery of life-saving therapies and cures.

Assay Guidance Manual: Quantitative Biology and Pharmacology in Preclinical Drug Discovery

“…There is considerable attention to reproducibility in translating basic discovery experiments from published data into discovery projects 43. Contributions to irreproducible results, artifactual bioactivity, and poorly tractable bioactivity can include assay reagents, data analysis methods, test compounds, instrumentation, and contaminants.…”

La reproducibilidad de las investigaciones biomédicas: Quo vadis?

“…En la actualidad, se calcula que la tasa de irreproducibilidad acumulada en la investigación preclínica alcanza el 53% 20 . Entre las principales razones que provocan la falta de reproducibilidad de las investigaciones hay que mencionar a: a) los errores en el diseño del estudio; b) los problemas en los reactivos biológicos y materiales de referencia; y c) los sesgos y errores en el análisis y comunicación de los resultados.…”

A critical analysis of cancer biobank practices in relation to biospecimen quality

“…Biological reagents and reference materials have been described as the largest single contributor to irreproducibility of pre-clinical results (Freedman et al 2015). Ongoing difficulties in locating and obtaining appropriate biospecimens of high quality lead many biomarker researchers to continue to employ Bsamples of convenience^, which are by definition accessible, but of uncertain integrity (Anderson et al 2013).…”

“…Many researchers and commentators state that irreproducible pre-clinical data are largely responsible for the failure to translate research results to the clinic, and the need to improve the current situation has been widely recognised (Buck 2015;Freedman et al 2015;Ioannidis 2014). Inadequate reproducibility may be at least partially responsible for the mismatch identified between research inputs and outputs, such as improvements in human life expectancy between 1965 and 2014 (Bowen and Casadevall 2015).…”