Service and Software Solution for the Rigorous Design of Animal Studies

 描述：这个快速通道项目的主要目标是将基于云的软件套件商业化，并辅之以随叫随到的专家服务，以指导可能具有最低统计和实验设计(ED)知识的生命科学研究人员严格计划、优化、调整、管理和报告复杂动物研究的结果。计划不充分的实验(例如，缺乏随机化/盲化和多样性、样本量小、测试变异性高等)可能会带来偏见和限制统计权力，这两者都可能导致对结果的曲解和资源的无效利用。这种缺陷和低质量的报告可能导致不可复制的结果，并可能误导科学界。使问题更加复杂的是研究本身的复杂性，例如物种多样性、品系/性别分组、下脚料、随机化、样本量、功率、采样时间、分析和处理计划、结果可变性以及成本权衡，所有这些都必须在优化急救系统时加以考虑。其中一些问题可能是由于缺乏统计人员、测试方法知识(即可变性)和规划工具，或缺乏教育方法方面的严格培训造成的。Seralogix创建了一个合作倡议，包括来自德克萨斯大学、FDA、犹他大学、爱丁堡大学和布罗德研究所的专家。为了解决这些问题，Seralogix和我们的合作伙伴将实施一个智能的、知识驱动的云应用和服务门户，用于ED规划和优化，称为统计严谨实验动物研究设计者(即Srewd)。我们相信，精明将导致动物使用的减少，财政和科学资源的节省，并将通过严格收集遵循良好规划和执行的实验设计的DAA来提高研究结果的科学有效性。

 DESCRIPTION: The primary goal of this fast track project is to commercialize a cloud-based software suite complemented with on-call expert services to guide life science researchers, that may have minimal statistical and experimental design (ED) knowledge, to rigorously plan, optimize, justify, manage, and report results for complex animal studies. Inadequately planned experiments (e.g. lack of randomization/blinding and diversity, low sample size, high test variabilities, etc.) can introduce bias and limit statistical power, both of which may lead to possible misinterpretations of results and ineffective use of resources. Such deficiencies and poor quality reporting can lead to irreproducible results and may mislead the scientific community. Compounding the problem is the complex nature of the studies themselves, such as species diversity, strain/sex groupings, litters, randomization, sample size, power, sampling times, analysis and treatment plans, outcome variability, and cost tradeoffs that all must be considered when optimizing EDs. Some of these issues may be caused by a lack of access to statisticians, test method knowledge (i.e. variabilities) and planning tools or a lack of rigorous training in ED methods. A collaborative initiative was created by Seralogix to include experts from the University of Texas, FDA, University of Utah, University of Edinburgh, and the Broad Institute. Addressing these issues, Seralogix and our collaborators will implement an intelligent, knowledge driven cloud application and service portal for ED planning and optimization called the Statistically Rigorous Experimental Animal Study Designer (i.e. SHREWD). We believe that SHREWD will lead to a reduction in animal use, savings in financial and scientific resources, and will improve the scientific validity of the study results through the rigorous collection of daa following well planned and executed experimental designs.