Abstract
Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs). We identified 130 potential SWFBs. All stakeholder groups agreed that ASRs could in various ways improve the quality and refinement of animal studies while allowing their number to be reduced, as well as supporting meta-research on animal studies. However, all stakeholder groups also highlighted the potential for theft of ideas, higher administrative burdens, and reduced creativity and serendipity in animal studies. Much more detailed reasoning was captured in the interviews than is currently found in the literature, providing a comprehensive account of the issues and arguments around ASRs. All stakeholder groups highlighted compelling potential strengths of ASRs. Although substantial weaknesses and implementation barriers were highlighted as well, different governance measures might help to minimize or even eliminate their impact. Such measures might include confidentiality time frames for accessing prospectively registered protocols, harmonized reporting requirements across ASRs, ethics reviews, lab notebooks, and journal submissions. The comprehensive information gathered in this study could help to guide a more evidence-based debate and to design pilot tests for ASRs.
Highlights
In recent years, several reports have questioned the way animal research is conducted and reported, citing a lack of reproducibility of preclinical animal research data and poor translation of published preclinical data into the human setting [1,2]
Incomplete reporting of studies and study results has been described as “publication bias,” “selective reporting,” and “dissemination bias” [3]. Whereas this bias has been studied in depth for clinical trials, less data is available for preclinical animal research
Analyses of dissemination bias in this field are more indirectly based on (A) data from survey research with animal researchers [13], (B) inferences from the debate about the relatively low reproducibility of preclinical research [14], (C) the high failure rate of early human trials [1,15], (D) statistical methods calculating the probability of bias in the available data [16,17], and (E) study abstracts published in conference proceedings or on their websites [18]
Summary
Several reports have questioned the way animal research is conducted and reported, citing a lack of reproducibility of preclinical animal research data and poor translation of published preclinical data into the human setting [1,2]. The comparison of trial registries and journal publications has allowed new kinds of analysis: following the rate and time of journal publication, analyzing possible factors influencing publication status (such as study type and funding source), as well as finding discrepancies between registry entries and data published in journals [9,10]. This approach has helped to quantify dissemination bias in clinical research and to define possible reasons and solutions [11,12]. Analyses of dissemination bias in this field are more indirectly based on (A) data from survey research with animal researchers [13], (B) inferences from the debate about the relatively low reproducibility of preclinical research [14], (C) the high failure rate of early human trials [1,15], (D) statistical methods calculating the probability of bias in the available data [16,17], and (E) study abstracts published in conference proceedings or on their websites [18]
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