Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.
Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.
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DOI：
10.1371/journal.pbio.2000391
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发表时间：
2016-11
期刊：
影响因子：
9.8
通讯作者：
Strech D
中科院分区：
文献类型：
--
作者：
Wieschowski S;Silva DS;Strech D
动物研究中的出版偏倚、其程度、预测因素及其潜在的对策越来越多地被讨论。最近的报告和会议强调了动物研究登记（ASR）在这方面的潜在优势。其他人警告说，动物研究的前瞻性注册可能会削弱创造力，增加行政负担，并使转化研究中的知识产权问题复杂化。进行了文献综述和21个国际关键知情人访谈，并进行了主题分析，以制定一个全面的矩阵的主要和子类别的潜在ASR相关的优势，劣势，促进者和障碍（SWFB）。我们确定了130个潜在的主权财富基金。所有利益攸关方团体都认为，自动化系统报告可以通过各种方式提高动物研究的质量和完善程度，同时减少动物研究的数量，并支持动物研究的元研究。然而，所有利益相关者团体也强调了在动物研究中窃取想法、增加行政负担以及减少创造力和意外发现的可能性。在访谈中捕获的推理比目前在文献中发现的要详细得多，提供了关于ASR的问题和论点的全面说明。所有利益相关者群体都强调了会计和报告的潜在优势。虽然也强调了重大弱点和执行障碍，但不同的治理措施可能有助于尽量减少甚至消除其影响。这些措施可能包括访问前瞻性注册方案的保密时间框架，统一ASR的报告要求，伦理审查，实验室笔记本和期刊提交。本研究中收集的全面信息可能有助于指导更加基于证据的辩论并设计针对自闭症谱系障碍的试点测试。过去几年中，动物研究中的“发表偏倚”和“再现性危机”引发了关于是否以及如何建立类似于临床试验注册的前瞻性动物研究注册（ASR）的辩论。然而，最近的所有辩论都遵循了相当宽泛的论证思路，并得出结论认为，今后关于审计、监督和报告问题的决策在很大程度上取决于更好地了解审计、监督和报告的相关特点和利益攸关方相互冲突的利益。在这方面，需要有更多的定性和系统的证据。因此，本研究的主要目标是系统地介绍ASR的所有相关优势、劣势、促进因素和障碍。为了实现这一目标，我们进行了系统的文献综述，并与来自临床前和临床研究、行业和监管机构的专家进行了21次关键知情人访谈。我们的调查导致了对130个关于ASR的问题和论点的全面和结构化的描述。未来关于审计和报告制度的辩论和决策可能会受到个别专家的论点和推理的严重影响，从而导致依赖专家意见的“基于声望”的决策。这项研究通过系统和透明的方法，围绕ASR的论点和问题进行了全面的研究，有助于平衡正在进行的辩论，从而促进更加循证的政策制定。
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. 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.
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影响因子：
9.8
作者：
Tsilidis KK;Panagiotou OA;Sena ES;Aretouli E;Evangelou E;Howells DW;Al-Shahi Salman R;Macleod MR;Ioannidis JP
通讯作者：
Ioannidis JP
影响因子：
15.8
作者：
van der Worp HB;Howells DW;Sena ES;Porritt MJ;Rewell S;O'Collins V;Macleod MR
通讯作者：
Macleod MR
DOI：
10.1016/j.zefq.2014.09.022
发表时间：
2014-01-01
影响因子：
1.1
作者：
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通讯作者：
Meerpohl, Joerg J.
影响因子：
15.8
作者：
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通讯作者：
Ritskes-Hoitinga M
影响因子：
120.7
作者：
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通讯作者：
Briel, Matthias