Abstract

Irreproducibility of preclinical biomedical research has gained recent attention. It is suggested that requiring authors to complete a checklist at the time of manuscript submission would improve the quality and transparency of scientific reporting, and ultimately enhance reproducibility. Whether a checklist enhances quality and transparency in reporting preclinical animal studies, however, has not been empirically studied. Here we searched two highly cited life science journals, one that requires a checklist at submission (Nature) and one that does not (Cell), to identify in vivo animal studies. After screening 943 articles, a total of 80 articles were identified in 2013 (pre-checklist) and 2015 (post-checklist), and included for the detailed evaluation of reporting methodological and analytical information. We compared the quality of reporting preclinical animal studies between the two journals, accounting for differences between journals and changes over time in reporting. We find that reporting of randomization, blinding, and sample-size estimation significantly improved when comparing Nature to Cell from 2013 to 2015, likely due to implementation of a checklist. Specifically, improvement in reporting of the three methodological information was at least three times greater when a mandatory checklist was implemented than when it was not. Reporting the sex of animals and the number of independent experiments performed also improved from 2013 to 2015, likely from factors not related to a checklist. Our study demonstrates that completing a checklist at manuscript submission is associated with improved reporting of key methodological information in preclinical animal studies.

Highlights

  • Preclinical biomedical research is essential for the development of breakthrough medical therapies

  • We evaluated the reporting of methodological information in Nature and Cell separately to determine whether changes in reporting behavior over time are different by journals

  • Our study shows that a required checklist at the time of manuscript submission improves the reporting of certain methodological information, such as randomization, blinding, and sample-size estimation, in preclinical in vivo animal studies

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Summary

Introduction

Preclinical biomedical research is essential for the development of breakthrough medical therapies. Human and animal biology are expected to be different, this alone does not explain the low rate of successful translation from animal studies to human trials. One pervasive concern is the low level of reproducibility of the results reported in preclinical studies [2, 3], where reproducibility generally refers to “a phenomenon that can be predicted to recur even when experimental conditions may vary to some degree [4].”. The term has been used differently in biostatistics [5], experimental biological scientists frequently use “reproducibility” to describe the ability to obtain the same scientific findings utilizing similar methods on identical test material by an independent observer [4, 6, 7]. The low level of reproducibility in biomedical experimental research has been attributed, in part, to variations in the quality of reporting of methods and results. One proposed solution to this matter is to improve the quality and transparency of reporting of preclinical research findings [8]

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