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学核心的重点是获取数据，数据管理，审核和 在微生物发展程序（MDP）的可访问数据库中分析全部。数据管理 目的是确保平等访问相关形式，数据库（试验CRF），监管文件，不良事件（AE） 所有计划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 面板（SAP）成员。同等重要的是该计划的团队成员能够查看自己的数据 通常在其他地方获得），可能位于不同的机构，并参与电视会议 讨论了对其他项目结果的评论，从而消除了对多重和笨拙的电子邮件附件的需求。 这种方法具有很大的优势，并且对这个基于该计划的效率和成功至关重要。一次 对数据进行了审查和最终确定，生物统计分析可以与所有相关的方式进行协调的方式进行 从同一锁定数据集工作的生物统计学家。该核心的另一个优势是加州大学洛杉矶分校CFAR Biostatistics核心主任兼BioStatistics部门主席William Cumberland博士的共同执行工作。对所有项目中统计和分析计划的这种监督都进行了协调，以确保方法的凝聚力，优化方法的整合，监督保护以及摘要能力，以帮助基于另一个项目的F'MDINGS对一个项目产生整体影响。我们要确保由于观察到的粘膜炎症而从开发中没有合理的杀菌剂候选者（项目4）消除，实际上可能是与COITUS（项目2）相关的创伤或以不可接受的配方制备的创伤的结果（项目3）。由于所有这些变量无法在一次试验中评估，因此基于共同采集技术，相似人群和相同单位的解释性预测将是本应用的优势之一，从而使总和大于各个部分。核心将促进统计人员与不同项目的调查人员之间的互动。关键功能将是鼓励统计人员之间的合作研究，以解决研究期间出现的生物统计问题。核心主任和联合导演将在所有涉及安全和数据审查的电信会议上以及准备DSMB报告的所有电信会议，目的是在这项新颖的合作研究中遇到的任何问题都将导致新的统计方法和出版物出版物回答研究问题。