Core--Administration, Data Management, and Biostatistics

核心——行政、数据管理和生物统计学

• 批准号: 7460902
• 负责人: BART BARLOGIE
• 金额: $ 81.82万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7460902
• 关键词: Accounting; Address; Administrative Coordination; Algorithms; Allogenic; Area; Arts; Assimilations; Autologous; Bioinformatics; Biological; Biometry; Bone Diseases; Bone Marrow; Clinic Visits; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Collection; Computers; Confidentiality; Consent; Crabs; Data; Data Analyses; Data Collection; Databases; Detection; Disease Progression; Drug effect disorder; Early Intervention; Effectiveness; Eligibility Determination; Enrollment; Ensure; Equipment; Equipment and Supplies; Etiology; Genetic; Genetic Models; Goals; Grant; Growth; Guidelines; Human Resources; Immune; Institutes; Investigation; Laboratories; Link; Manuscripts; Measurement; Methods; Molecular; Molecular Profiling; Monitor; Multiple Myeloma; Pathway interactions; Patients; Phase; Population; Preparation; Preventive; Proteomics; Protocol Compliance; Protocols documentation; Relapse; Research; Research Activity; Research Design; Research Ethics Committees; Research Infrastructure; Research Personnel; Resistance; Resources; Role; Sampling; Schedule; Science; Secure; Security; Services; Shipping; Ships; Specimen; Staging; Standards of Weights and Measures; Statistical Methods; Statistical Models; Systematic Bias; Technology; Therapeutic; Time; Toxic effect; Travel; Treatment Failure; United States National Institutes of Health; Vertebral column; Work; Writing; concept; data management; data mining; design; early onset; experience; extracellular; interest; novel diagnostics; programs; protocol development; quality assurance; success; symposium; therapeutic target; translational study

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.

这个核心，行政，数据管理和生物统计学的主要目标是支持多发性骨髓瘤生长控制计划项目。P01的所有项目和核心都需要研究和行政协调，管理与患者有关的数据，并对数据进行统计分析。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有助于采取综合办法，最大限度地利用现有资源。这些服务的提供对于基础、临床和转化性研究之间的有效协同至关重要，这些研究是该计划项目的支柱。核心A的具体目标如下。目标1.向所有项目和核心提供行政支助，使研究活动与适当的互动协调起来，以完成 P01的总体目标。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研究和赞助项目办公室的协调，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，以及与骨髓瘤研究所的数据管理部协调，以确保准确和及时地收集临床试验数据。目标2.管理整体数据基础设施。这包括维护临床数据库；通过安全路径以电子方式传输数据；跟踪样本并核实在正确的时间将必要的材料送到正确的实验室；确保所有数据的安全性和保密性；协调吸收必要的数据进行分析，包括核实资格、同意患者 到协议，并确保协议合规性。目的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、总体和实验参数，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和实施量化方法，以解决感兴趣的科学问题，并对支持各种研究假设的证据提供有效的统计推断。