Examinations of any experiment involving living organisms require justifications of the need and moral defensibleness of the study. Statistical planning, design and sample size calculation of the experiment are no less important review criteria than general medical and ethical points to consider. Errors made in the statistical planning and data evaluation phase can have severe consequences on both results and conclusions. They might proliferate and thus impact future trials-an unintended outcome of fundamental research with profound ethical consequences. Therefore, any trial must be efficient in both a medical and statistical way in answering the questions of interests to be considered as approvable. Unified statistical standards are currently missing for animal review boards in Germany. In order to accompany, we developed a biometric form to be filled and handed in with the proposal at the local authority on animal welfare. It addresses relevant points to consider for biostatistical planning of animal experiments and can help both the applicants and the reviewers in overseeing the entire experiment(s) planned. Furthermore, the form might also aid in meeting the current standards set by the 3+3R's principle of animal experimentation Replacement, Reduction, Refinement as well as Robustness, Registration and Reporting. The form has already been in use by the local authority of animal welfare in Berlin, Germany. In addition, we provide reference to our user guide giving more detailed explanation and examples for each section of the biometric form. Unifying the set of biostatistical aspects will help both the applicants and the reviewers to equal standards and increase quality of preclinical research projects, also for translational, multicenter, or international studies.
翻译:任何涉及活生物体的实验的检查都需要说明研究的必要性和道德理由。实验的统计规划、设计和抽样规模的计算比一般医学和伦理标准要重要得多。统计规划和数据评价阶段的错误可能对结果和结论都产生严重后果。它们可能会扩散,从而影响未来试验的意外结果,并产生深刻的道德后果。因此,任何试验都必须在医学和统计两方面都有效,以解答利益问题,视之为可验证。德国动物审查委员会目前缺乏统一的统计标准。为配合起见,我们开发了一个生物鉴别表,供当地动物福利主管部门填写和提交提案。统计规划和数据评价阶段的错误可能会对结果和结论产生严重影响。这些错误可能会扩散,从而影响未来基本研究的无意结果,从而产生深刻的道德后果。因此,任何试验必须以医学和统计方式有效地回答目前由3+3R原则确定的利益,即动物实验的替换、减少、精细化以及机械化、登记和报告标准。为了配合,我们为动物福利和生物标准化的每个用户标准,我们已在柏林的每个标准中提供更详尽的参考。