Abstract

Non-publication and publication bias in animal research is a core topic in current debates on the “reproducibility crisis” and “failure rates in clinical research”. To date, however, we lack reliable evidence on the extent of non-publication in animal research. We collected a random and stratified sample (n = 210) from all archived animal study protocols of two major German UMCs (university medical centres) and tracked their results publication. The overall publication rate was 67%. Excluding doctoral theses as results publications, the publication rate decreased to 58%. We did not find substantial differences in publication rates with regard to i) the year of animal study approval, ii) the two UMCs, iii) the animal type (rodents vs. non-rodents), iv) the scope of research (basic vs. preclinical), or v) the discipline of the applicant. Via the most reliable assessment strategy currently available, our study confirms that the non-publication of results from animal studies conducted at UMCs is relatively common. The non-publication of 33% of all animal studies is problematic for the following reasons: A) the primary legitimation of animal research, which is the intended knowledge gain for the wider scientific community, B) the waste of public resources, C) the unnecessary repetition of animal studies, and D) incomplete and potentially biased preclinical evidence for decision making on launching early human trials. Results dissemination should become a professional standard for animal research. Academic institutions and research funders should develop effective policies in this regard.

Highlights

  • Animal research plays a crucial role in advancing our knowledge about biological processes and in developing safe and effective therapies, such as antibiotics, insulin, vaccines and organ transplantation [1, 2] [3]

  • A tracking activity for studies reported in animal research abstracts presented at the 2008 Society of Critical Care Medicine Conference indicated that 38% had not been published by 2017 [5]

  • An assessment of publication bias in systematic reviews of interventions tested in animal studies of acute ischaemic stroke estimated a non-publication rate of 14% [6]

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Summary

Introduction

Animal research plays a crucial role in advancing our knowledge about biological processes and in developing safe and effective therapies, such as antibiotics, insulin, vaccines and organ transplantation [1, 2] [3]. To realize a broad knowledge gain for the wider scientific community and interested public, the results of animal studies need to be published via peer-reviewed journals or other accessible dissemination formats. A tracking activity for studies reported in animal research abstracts presented at the 2008 Society of Critical Care Medicine Conference indicated that 38% had not been published by 2017 [5]. All of the abovementioned studies, applied assessment measures with limited reliability: i) Surveys assess only subjective opinions; ii) sampling conference abstracts as a starting point for assessing publication rates might already imply a bias towards desired outcomes; and iii) statistical and graphical methods to detect bias in meta-analyses, e.g., funnel-plots, bear several risks regarding misleading information [7]

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