BIOSTATISTICS CORE

生物统计学核心将进行互动并提供统计支持。我们将在研究进展的每一步为项目提供设计和统计咨询支持，并为通常复杂的数据提供最先进的统计分析。数据收集、管理和存储也是生物统计核心和PPG整体成功的关键组成部分。生物统计学核心统计学家在临床试验和实验室结果方面拥有丰富的经验，除了在认为有用的情况下进行充分合作外，还将提供设计和分析咨询。2.1项目运营核心成员将协助项目活动过程中产生的数据的设计、收集、存储、质量控制、可视化、分析、定量建模和解释。他们将通过参与以下活动来实现这些目标：帮助制定和发展一个重要的科学问题，使其成为一个可行的和适当的研究设计，使研究能够达到其既定的目标。就项目进展中可能需要对研究设计进行的任何修改提出建议。必要时开发非标准研究设计，以实现特定的研究目标。确保研究目的、合格标准、主要和次要分析终点以及评价标准的定义清晰一致。建立并执行质量控制程序。适当时，实施研究数据的中期监测和分析计划。设计、执行和呈现统计分析。必要时开发新的非标准分析工具，以实现研究特定或程序目标。对新工具进行相关的方法研究和评价。积极参与PPG范围内和项目特定会议。根据研究结果合作编写手稿和摘要。<$组织教育会议，向研究人员介绍方法和软件，并在必要时培训研究员和数据协调员<$在临床试验和实验室实验中，指导研究员和初级教师使用定量研究方法。这些步骤的成功实施需要核心调查员和项目调查员之间进行坚定和结构化的互动，并沿着以下原则进行：1）所有项目的所有目标都有一名核心成员作为共同调查员;在适当的情况下，他/她也将是手稿的共同作者2）研究者将定期与核心成员会面，以更新正在进行的研究并讨论和设计新的研究，3）关于可行性、实验设计和数据库问题的咨询将作为研究开发的一个组成部分与临床和生物学讨论一起提供，4）关于数据可视化和探索性技术的咨询和建议将持续提供，并作为研究开发的一个组成部分。这些战略的基础是核心生物统计学家在项目重要领域的广泛专业知识，以及在跨学科环境中使用定量方法进行转化研究的承诺。PPG将定期（至少每月一次）开会，讨论项目、进展情况，并为新的成果和想法提供一个论坛。生物统计学核心成员将参加这些会议，以及时了解项目进展，并就研究设计、数据收集和样本量考虑事项向项目负责人提供咨询。这些多学科会议将是项目编制小组的一个重要组成部分，有助于项目与核心之间的互动。

The Biostatistics Core will interact and provide statistical support. We will support projects with design and statistical consultation at each step of a study's progress, and provide state-of-the-art statistical analyses of often complex data. Data collection, management, and storage are also key components of the success of the Biostatistics Core and the PPG as a whole. The Biostatistics Core statisticians have extensive experience with both clinical trials and laboratory outcomes and will provide design and analysis consultation in addition to fully collaborating whenever it is deemed useful. 2.1 Projected Operation Core members will assist in the design, collection, storage, quality control, visualization, analysis, quantitative modeling, and interpretation of data arising in the course of program activities. They will accomplish these goals by engaging in the following activities: ¿ Help formulating and developing an important scientific question into a feasible and appropriate study design that will allow the study to meet its stated objectives. Advise on any modifications in study designs that might become necessary as a Project progresses. ¿ Develop non-standard study designs when necessary to achieve specific study objectives. ¿ Ensure that there are clear and consistent definitions of study objectives, eligibility criteria, primary and secondary endpoints for analysis, and evaluation criteria. ¿ Establish and conduct quality control procedures. Implement plans for interim monitoring and analyses of study data when appropriate. ¿ Design, perform, and present statistical analyses. ¿ Develop new, non-standard analysis tools when necessary to achieve study-specific or Programmatic goals. Conduct relevant methodological research and evaluation of the new tools. ¿ Actively participate in PPG-wide and Project specific meetings. ¿ Collaborate in the preparation of manuscripts and abstracts based on study results. ¿ Organize educational sessions to inform investigators about methods and software and train fellows and data coordinators when necessary ¿ Mentor fellows and junior faculty with regard to quantitative research methods, both in clinical trials and laboratory experiments. Successful implementation of these steps requires a committed and structured interaction between Core and Project investigators, proceeding along the following lines: 1) all aims of all Projects have a Core member as a co-investigator; whenever appropriate he/she will also be co-author of manuscripts 2) investigators will meet with the Core member on a regular basis for updates on ongoing studies and to discuss and design new studies, 3) consultation regarding feasibility, experimental design, and database issues will be provided as an integral part of study development along with the clinical and biological discussions, 4) consultation and advice regarding data visualization and exploratory techniques will be provided on an ongoing basis and as an integral part of study development. The basis for these strategies is in the Core biostatisticians' extensive expertise in areas important to the Projects, and in the demonstrated commitment to using quantitative methodology in interdisciplinary settings to pursue translational research. The PPG will meet regularly (at least monthly) to discuss projects, progress, and to allow a forum for new results and ideas. The Biostatistics Core members will participate in these meetings to keep abreast of Project developments and to provide consultation to Project leaders with regards to study design, data collection, and sample size considerations. These multidisciplinary meetings will be a critical component of the PPG, aiding in interaction between projects and cores.