Data management and biostatistics

数据管理和生物统计学

• 批准号: 7979343
• 负责人: Peter A Anton
• 金额: $ 6.27万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-18 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7979343
• 关键词: Adverse event; Biometry; Biostatistics Core; Coitus; Data; Data Set; Databases; Development; Drug Formulations; Electronic Mail; Ensure; Human Resources; Institution; Lead; Methods; Mucositis; Participant; Population; Preparation; Program Development; Publications; Reporting; Research; Research Personnel; Safety; Sum; Techniques; Teleconferences; Trauma; United States National Institutes of Health; Work; base; data acquisition; data management; member; microbicide; novel; programs; statistics; success; web-accessible

The focus of the Data Management & Biostatistics Core is the acquisition of data, data management, review and analysis all on a web-accessible database for the Microbicide Development Program (MDP). The data management aims are to ensure equal access to relevant forms, databases (trial CRFs), regulatory documents, adverse event (AE) reports and iterative data/results for all program participants, including NIH Project Officers and Scientific Advisory Panel (SAP) members. Of equal importance is for the Program's team members to be able to review their own data often acquired elsewhere), which may be located at different institutions, as well as to participate in teleconferences vhere review of other Projects' results are discussed, eliminating need for multiple and unwieldy email attachments. This approach has great strengths and is pivotal to the efficiency and success of this broadly based program. Once data is reviewed and finalized, biostatistical analysis can proceed in a coordinated fashion with all associated biostatisticians working from the same locked datasets. An additional advantage of this Core is the Co-Directorship of Dr. William Cumberland, Director of the UCLA CFAR Biostatistics Core and Chair of the Biostatistics Department at UCLA. This oversight of statistical and analysis plans in all projects is coordinated to ensure cohesiveness of approach, integration of optimized methods, oversight protection and the summary capacity to assist in overall implications for one project based on f'mdings in another project. We want to ensure that no reasonable microbicide candidate is eliminated from development (Project 4), due to observed mucosal inflammation that may, in fact, be a consequence of trauma related to coitus (Project 2) or prepared in an unacceptable formulation (Project 3). As all these variables can not be evaluated in a single trial, interpretative projections based on common acquisition techniques, similar populations and identical units, will be one of the strengths of this application, making the sum greater than the parts. The Core will facilitate interaction between the statistical personnel and the investigators of the different projects. Key functions will be to encourage collaborative research among the statistical personnel to solve biostatistical problems that arise during the studies. The Core Director & Co-Director will be represented on all teleconferences involving safety and data review as well as in preparation of DSMB reports with the intent that any problems encountered during this novel collaborative research will lead to new statistics methods and publications answer study questions.

数据管理和生物统计核心的重点是数据的获取、数据管理、审查和 为杀微生物剂发展计划(MDP)建立一个网上可访问的数据库进行分析。数据管理 目的是确保平等获取相关表格、数据库(试验CRF)、法规文件、不良事件(AE) 所有项目参与者的报告和迭代数据/结果，包括NIH项目官员和科学咨询 小组(SAP)成员。同样重要的是，该计划的团队成员能够审查他们自己的数据 通常在其他地方获得)，可能设在不同的机构，以及参加电话会议 讨论了对其他项目结果的审查，消除了对多个和笨拙的电子邮件附件的需要。 这种方法具有很大的优势，是这一基础广泛的计划的效率和成功的关键。一次 数据被审查和最终敲定，生物统计分析可以以协调的方式进行，所有相关的 生物统计学家使用相同的锁定数据集进行工作。这一核心的另一个优势是由加州大学洛杉矶分校CFAR生物统计核心主任兼加州大学洛杉矶分校生物统计系主任威廉·坎伯兰博士担任共同董事。协调对所有项目的统计和分析计划的监督，以确保方法的连贯性、优化方法的整合、监督保护和汇总能力，以根据一个项目在另一个项目中的建议协助对另一个项目的整体影响。我们希望确保没有合理的杀微生物剂候选者被排除在开发过程中(项目4)，因为观察到的粘膜炎症实际上可能是与性交相关的创伤(项目2)或以不可接受的配方制备的(项目3)。由于不能在一次试验中评估所有这些变量，基于共同获取技术、相似总体和相同单位的解释性预测将是这一应用的优势之一，使总和大于部分。核心将促进统计人员与不同项目的调查员之间的互动。主要职能将是鼓励统计人员进行合作研究，以解决研究期间出现的生物统计学问题。核心主任和联席主任将派代表参加所有涉及安全和数据审查的电话会议，以及编写DSMB报告，目的是在这一新的合作研究期间遇到的任何问题将导致新的统计方法和出版物回答研究问题。