Data management and biostatistics

数据管理和生物统计学

基本信息

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
项目类别：
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

项目摘要

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获取、数据管理、审查和所有分析均在可通过网络访问的杀菌剂开发计划 (MDP) 数据库上进行。数据管理目标是确保平等获取相关表格、数据库（试验 CRF）、监管文件、不良事件 (AE) 为所有计划参与者（包括 NIH 项目官员和科学咨询）提供报告和迭代数据/结果小组 (SAP) 成员。同样重要的是该计划的团队成员能够审查自己的数据通常在其他地方获得），可能位于不同的机构，以及参加电话会议此处讨论了对其他项目结果的审查，从而消除了对多个且笨重的电子邮件附件的需要。这种方法具有很大的优势，对于这个基础广泛的计划的效率和成功至关重要。一次数据经过审查和最终确定后，生物统计分析可以与所有相关的协调方式进行生物统计学家使用相同的锁定数据集进行工作。该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 William Cumberland 博士担任联合主任。对所有项目中的统计和分析计划的监督是协调一致的，以确保方法的一致性、优化方法的整合、监督保护和总结能力，以协助根据另一个项目的调查结果对一个项目产生总体影响。我们希望确保没有合理的候选杀菌剂被从开发中消除（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结果（项目 3））。由于所有这些变量无法在一次试验中进行评估，因此基于常见采集技术、相似群体和相同单位的解释性预测将成为该应用程序的优势之一，使总和大于各个部分。该核心将促进统计人员和不同项目的调查人员之间的互动。主要职能是鼓励统计人员之间的合作研究，以解决研究过程中出现的生物统计问题。核心主任和联合主任将出席所有涉及安全和数据审查的电话会议以及 DSMB 报告的准备工作，目的是使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回答研究问题。