Core--Administration, Data Management, and Biostatistics

核心——行政、数据管理和生物统计学

• 批准号: 6997920
• 负责人: BART BARLOGIE
• 金额: $ 53.19万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-16 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6997920
• 关键词: biomedical facility; data management; multiple myeloma; statistics /biometry

The primary objective of this core, Administration, Data Management, and Biostatistics, is to support the Growth Control of Multiple Myeloma Program Project. All projects and cores of the P01 will require research and administrative coordination, management of patient-related data, and statistical analysis of data. Core A will encompass all of these services and provide them in a coordinated fashion so that all projects and cores contribute to a comprehensive approach, maximizing available resources. Provision of these services is fundamental to effective synergy among the basic, clinical, and translational studies that are the backbone of the Program Project. Core A's specific aims are as follows. Aim 1. Provide administrative support to all projects and cores, such that research activities are coordinated with appropriate interaction to accomplish goals of the overall P01. Administrative activities will include scheduling and management related to advisory meetings and regular meetings among investigators, coordination with the UAMS Office of Research and Sponsored Programs and Grants Accounting to ensure compliance with NIH guidelines and requirements, coordination with CRAB to ensure that data analysis needs are met, and coordination with the Data Management division of the Myeloma Institute to ensure accurate and timely collection of clinical trial data. Aim 2. Manage the overall data infrastructure. This includes maintaining the clinical database; electronic transfer of data over secure pathways; tracking samples and verifying that the necessary material is sent to the correct laboratory at the correct time; ensuring security and confidentiality of all data; and coordinating the assimilation of necessary data for analysis, including verifying eligibility, consenting patients to protocols, and ensuring protocol compliance. Aim 3. Provide biostatistical support to link study design, data collection, measurement, and analysis to the research hypotheses and questions under investigation in the P01. In the early stages, biostatisticians will work with investigators to define study hypotheses and populations and experimental parameters to answer the research questions of interest, reduce systematic bias, and ensure a high likelihood of detection of biologically meaningful effects. At the analysis stage, biostatisticians will identify and implement quantitative methods to address scientific questions of interest and provide valid statistical inferences about evidence supporting the various study hypotheses.

该核心（管理、数据管理和生物统计学）的主要目标是支持多发性骨髓瘤计划项目的生长控制。 P01 的所有项目和核心都需要研究和行政协调、患者相关数据的管理以及数据的统计分析。核心 A 将涵盖所有这些服务，并以协调的方式提供这些服务，以便所有项目和核心都有助于采取全面的方法，最大限度地利用可用资源。提供这些服务对于作为该计划项目支柱的基础、临床和转化研究之间的有效协同至关重要。核心A的具体目标如下。目标 1. 为所有项目和核心提供行政支持，使研究活动与适当的互动相协调，以完成 总体目标P01。行政活动将包括与咨询会议和研究人员定期会议相关的日程安排和管理，与 UAMS 研究和资助计划和拨款会计办公室协调，以确保遵守 NIH 指南和要求，与 CRAB 协调，以确保满足数据分析需求，并与骨髓瘤研究所数据管理部门协调，确保临床试验数据的准确、及时收集。目标 2. 管理整体数据基础设施。这包括维护临床数据库；通过安全路径进行电子数据传输；跟踪样品并验证必要的材料是否在正确的时间发送到正确的实验室；确保所有数据的安全性和机密性；协调分析所需数据的吸收，包括验证资格、征得患者同意 协议，并确保协议合规性。目标 3. 提供生物统计学支持，将研究设计、数据收集、测量和分析与 P01 中正在调查的研究假设和问题联系起来。在早期阶段，生物统计学家将与研究人员合作，定义研究假设、群体和实验参数，以回答感兴趣的研究问题，减少系统偏差，并确保检测到具有生物学意义的效应的高可能性。在分析阶段，生物统计学家将确定并实施定量方法来解决感兴趣的科学问题，并就支持各种研究假设的证据提供有效的统计推论。