Biostatistics and Bioinformatics Core

项目摘要/摘要 部署适当的分析技术和仔细的数据管理是必不可少的组成部分 所有罗斯威尔公园卵巢癌孢子项目。生物统计和生物信息学核心(核心C)将 确保所有孢子都能随时获得必要的生物统计学和生物信息学支持和资源 研究项目。核心项目的目标是提高个人研究项目的生产率 调查人员，减少获得分析专业知识的障碍，保持高标准的数据收集和 管理、设计和执行严格的分析策略，并促进协作和支持 研究社区。 生物统计和生物信息学核心将协助孢子的基础、翻译和临床研究人员 通过应用适当的生物统计学，适当地制定、细化和执行研究目标 和生物信息学分析，并从这两个方面对其结果进行适当的解释 优势和局限性。我们将确保发展性研究计划和职业生涯优先 从生物统计学和生物信息学的角度来看，增强计划项目是可行的。这个 生物统计和生物信息学核心将确保收集到适当的数据；这些数据是最高的 质量并满足隐私监管标准；这些数据是回答研究问题所需的数据， 行政报告所必需的，建立协议合规性所必需的，和/或将包括在 手稿。我们将准备数据安全监测委员会的报告，并将临床试验结果发布到临床试验网站。 及时合规，确保符合NIH政策，并协助孢子数据共享 数据通过NCI癌症研究数据共享基础设施和类似的NIH指定的数据存储库进行。 生物统计和生物信息学核心将开发和实施新的和新的统计和生物信息学 解决所有研究目标所需的方法和相关软件。我们将实施软件 解决方案和最佳实践，以促进稳健和可重复的研究。我们建议的生物统计学和 生物信息学核心将利用一些现有的、运转良好的、由NCI资助的单位，这些单位位于 罗斯威尔公园生物统计和生物信息学系。

PROJECT SUMMARY/ABSTRACT The deployment of appropriate analytic techniques and careful data management are an essential component for all Roswell Park Ovarian Cancer SPORE projects. The Biostatistics and Bioinformatics Core (Core C) will ensure that essential biostatistics and bioinformatics supports and resources are readily available to all SPORE research projects. The goals of the Core are to improve the productivity of the Individual Research Project investigators, reduce the barriers for access to analytic expertise, maintain high standards for data collection and management, design and perform rigorous analytical strategies, and foster a collaborative and supportive research community. The Biostatistics and Bioinformatics Core will assist basic, translational and clinical researchers of the SPORE with proper formulation, refinement and execution of study objectives by applying the appropriate biostatistics and bioinformatics analyses, and providing the appropriate interpretation of their results, in terms of both strengths and limitations. We will ensure a priori that Developmental Research Program and Career Enhancement Program projects are feasible from a biostatistical and bioinformatics perspective. The Biostatistics and Bioinformatics Core will ensure that appropriate data are collected; the data are of the highest quality and meet regulatory standards for privacy; and the data are those required to answer a study question, necessary for administrative reporting, needed to establish protocol compliance, and/or will be included in a manuscript. We will prepare Data Safety Monitoring Board reports and post clinical trial results to clinicaltrials.gov in a timely and compliant manner and ensure compliance to NIH policy and assist with data sharing of SPORE data via the NCI Cancer Research Data Commons infrastructure and similar NIH-designated data repositories. The Biostatistics and Bioinformatics Core will develop and implement new and novel statistical and bioinformatics methodology and the related software as needed to address all study objectives. We will implement software solution and best practice to boost robust and reproducible research. Our proposed Biostatistics and Bioinformatics Core will capitalize on a number of existing, well-functioning, NCI-funded units housed within the Roswell Park Department of Biostatistics and Bioinformatics.