Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers

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.Author Summary: The manifold contributions over the last years on “publication bias” and “reproducibility crisis” in animal research initiated a debate on whether and how prospective animal study registries (ASRs) should be established in analogy to clinical trial registries. All recent debate, however, followed rather broad lines of argumentation and concluded that future decision-making on the issue of ASRs depends strongly on better knowledge about relevant characteristics of ASRs and about conflicting stakeholder interests. More qualitative but systematically developed evidence in this regard is needed. The primary objective of this study, therefore, was to present a systematically derived spectrum of all relevant strengths, weaknesses, facilitators and barriers (SWFBs) for ASRs. A systematic literature review and 21 key-informant interviews with experts from preclinical and clinical research, industry, and regulatory bodies were conducted to fulfill this objective. Our investigations resulted in a comprehensive and structured account of 130 issues and arguments around ASRs. Future debate and decision-making on ASRs might be heavily influenced by arguments and reasoning from individual experts and thus result in “eminence-based” policy making that relies on expert opinion. This study’s comprehensive spectrum of arguments and issues around ASR, developed through systematic and transparent methods, helps to balance the ongoing debate and thus facilitate a more evidence-based policy making.