Patient Recruitment and Data Analysis

患者招募和数据分析

• 批准号: 8380129
• 负责人: Jerry A. Krishnan
• 金额: $ 69.37万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8380129
• 关键词: Allergic Disease; Asthma; Biological; Bronchoscopy; Budgets; Case Report Form; Chicago; Clinical; Clinical Distribution; Clinical Research; Clinical Trials; Collection; Complement; Data; Data Analyses; Data Collection; Disease; Doctor of Philosophy; Enrollment; Ensure; Epidemiology; Funding; HLA G antigen; Head; Human Genetics; Human Subject Research; Institutional Review Boards; Knowledge; Lead; Lung; Manuscripts; Medicine; Monitor; National Institute of Allergy and Infectious Disease; Online Systems; Participant; Patient Recruitments; Patients; Performance; Phase; Physicians; Physiological; Procedures; Protocols documentation; Quality Control; Recruitment Activity; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Resources; Safety; Secure; Specimen; Study Subject; System; United States National Institutes of Health; Universities; Work; abstracting; airway inflammation; data management; design; experience; improved; meetings; professor; quality assurance; statistics; transmission process

The Patient Recruitment and Data Analysis Core (PRDAC) is an assembly of experienced investigators, staff, and material resources that will provide vital infrastructure support to this Asthma and Allergic Diseases Cooperative Research Center (AADCRC) application. The PRDAC is headed by Dr. Jerry A. Krishnan, MD, PhD, Associate Professor of Medicine and Epidemiology, Director of the Department of Medicine Data Management and Statistics Core, and a board-certified pulmonary physician with expertise in clinical investigation in asthma. Dr. Dan Nicolae, PhD, Associate Professor of Human Genetics and Statistics, will be the lead statistician in the PRDAC and will serve as core co-Leader. The PRDAC will be responsible for managing the recruitment of participants for the clinical studies as well as the performance of high quality data management and statistical analysis functions for this AADCRC application. Participant recruitment is one of the most demanding aspects of clinical studies and the expertise and resources it requires are frequently underestimated. We are currently recruiting subjects for multiple NIH-funded studies in airway disease and this work has allowed us to develop the appropriate expertise and an understanding of the resources needed to successfully screen, approach, and enroll study subjects, to collect clinical, physiologic, and biological data (including airway specimens from bronchoscopy) using research protocols, and to perform high-quality data management/statistical analysis. We have taken advantage of this collective experience in designing the proposed PRDAC and PRDAC budget. The three projects will recruit from a common pool of patients with asthma. Therefore, we elected to coordinate our recruitment efforts through the PRDAC to: 1) eliminate the need to duplicate or to compete for recruitment-related resources, thereby improving the efficiency with which our investigators meet enrollment targets, and 2) ensure that a uniform baseline characterization of asthma is employed across projects, permitting the opportunity for cross-study syntheses of findings. The PRDAC will be responsible for coordinating and developing reports for patient recruitment and human subjects research activities for our Data Safety and Monitoring Plan for review by the University of Chicago IRB and by the NIAID Project officer. In addition, the PRDAC will collaborate with project leaders and co-investigators within other projects/cores to ensure a timely transmission of findings via reports, abstracts, and manuscripts. The PRDAC, therefore, will facilitate the efficient and successful completion of studies proposed in each project and promote the synthesis and dissemination of knowledge gained across the various studies.

患者招募和数据分析核心(PRDAC)是由经验丰富的调查人员组成的集合， 将为哮喘和过敏性疾病合作研究中心(AADCRC)应用程序提供重要基础设施支持的人员和物质资源。PRDAC由曾傑瑞·A·克里希南博士领导， 医学博士，医学与流行病学副教授，医学系主任 数据管理和统计核心，以及具有临床专业知识的委员会认证的肺部医生 哮喘的调查。丹·尼古拉博士，人类遗传学和统计学副教授，将 担任PRDAC的首席统计师，并将担任核心联合领导人。PRDAC将负责 管理临床研究参与者的招募以及高质量数据的表现 此AADCRC应用程序的管理和统计分析功能。参与者招聘是其中之一 临床研究最苛刻的方面以及它所需要的专业知识和资源经常是 被低估了。我们目前正在为NIH资助的多项呼吸道疾病研究招募研究对象 这项工作使我们能够发展适当的专门知识，并了解所需的资源。 成功筛选、接近和招募研究对象，收集临床、生理和生物学数据 (包括来自支气管镜检查的呼吸道样本)使用研究方案，并执行高质量数据 管理/统计分析。我们利用这一集体经验设计了 拟议的PRDAC和PRDAC预算。这三个项目将从共同的患者池中招募 哮喘。因此，我们选择通过PRDAC协调我们的招聘工作：1)消除 需要复制或竞争与招聘有关的资源，从而提高效率 我们的研究人员达到了登记目标，2)确保哮喘的统一基线特征是 跨项目使用，允许有机会对结果进行交叉研究综合。PRDAC将 负责协调和开发患者招募和人体研究的报告 我们的数据安全和监控计划的活动，供芝加哥大学IRB和 NIAID项目官员。此外，PRDAC将与项目负责人和协查人员在 其他项目/核心，以确保通过报告、摘要和手稿及时传递调查结果。这个 因此，发展与发展谘询委员会将协助有效率及成功地完成每项计划所建议的研究。 并促进综合和传播在各种研究中获得的知识。