Biostatistics and Data Coordinating Core (BDCC)

生物统计和数据协调核心 (BDCC)

• 批准号: 8555159
• 负责人: Mary E. Putt
• 金额: $ 17.36万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-07 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8555159
• 关键词: Address; Animal Model; Animals; Basic Science; Biometry; Borderline Personality Disorder; Bronchopulmonary Dysplasia; Carcinomatosis; Case Report Form; Cell Line; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Code; Collaborations; Computer software; Consult; Data; Data Analyses; Data Collection; Data Quality; Databases; Disease; Enrollment; Generations; Goals; Graph; Heterogeneity; Human; Human Resources; Immunohistochemistry; In Vitro; Laboratories; Laboratory Study; Lead; Malignant Neoplasms; Malignant neoplasm of lung; Manuscripts; Maximum Tolerated Dose; Measures; Mediating; Methods; Microscopic; Modification; Monitor; Monoclonal Antibody C225; Non-Small-Cell Lung Carcinoma; Operative Surgical Procedures; Ovarian; Patient Recruitments; Patients; Pennsylvania; Peritoneal; Phase I Clinical Trials; Phase II Clinical Trials; Photochemotherapy; Physics; Physiological; Physiology; Pleural; Porfimer Sodium; Preparation; Procedures; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Safety; Sample Size; Secondary to; Services; Specialist; Staging; Statistical Data Interpretation; Statistical Methods; Surface; System; Testing; Time; Toxic effect; Translational Research; Universities; Validation; Work; Writing; abstracting; anticancer research; clinical epidemiology; data management; database structure; design; experience; gastrointestinal; innovation; medical schools; member; multidisciplinary; neoplastic; peritoneal cancer; preclinical study; professor; programs; quality assurance; tumor

The goals of Core C (Biostatistics and Data Management) are to provide expert biostatistical guidance in the design, conduct and analysis of research projects comprising the P01, and to provide a reliable and accurate data management system for projects involving clinical data. The aims of Core C are to provide biostatistical support to P01 projects at every stage of the research: Prior to the initiation of studies, Core staff will consult with investigators to help them select efficient designs and sample sizes that will give adequate power to address study objectives. For clinical studies, they will work with investigators to help set up effective patient recruitment strategies and design case report forms that collect all required information in an unambiguous way. As studies proceed, Core staff will assist in reviewing project databases and monitoring the quantity and quality of data collected, and will suggest modifications to the design or analysis plan as appropriate. When studies are finished, the Core will conduct correct and efficient data analyses, prepare any necessary graphs and tables, assist investigators with the preparation of presentations and manuscripts, and consult on the design of subsequent research. The work of Core C will interface with that of the Physics core providing data management activities during clinical projects, and with the Animal core as laboratory studies are planned and executed. The Core C staff members have extensive experience supporting cancer research, with strong backgrounds in basic science, translational research and clinical trials in addition to being themselves researchers in statistical methods. With their many years of experience with the PDT group, they look forward to further collaborative opportunities for both applying existing methods and adapting or developing new methods as needed.

核心C（生物统计学和数据管理）的目标是在包括P01的研究项目的设计，进行和分析中提供专家生物统计学指导，并为涉及临床数据的项目提供可靠，准确的数据管理系统。核心C的目的是在研究的每个阶段为P01项目提供生物统计学支持：在启动研究之前，核心员工将咨询研究人员，以帮助他们选择有效的设计和样本量，以赋予足够的权力来解决研究目标。对于临床研究，他们将与研究人员合作，以帮助建立有效的患者招聘策略和设计案例报告表，以明确的方式收集所有必需的信息。随着研究的进行，核心人员将协助审查项目数据库并监视收集的数据的数量和质量，并建议对设计或分析计划进行适当的修改。研究完成后，核心将进行正确有效的数据分析，准备任何必要的图表和表格，协助研究人员准备演示和手稿，并就随后的研究设计进行咨询。 Core C的工作将与在临床项目期间提供数据管理活动的物理核心的工作，并计划和执行动物核心。 C核心工作人员在支持癌症研究方面具有丰富的经验，除了自己是统计方法的研究人员外，基础科学，转化研究和临床试验的背景强大。凭借在PDT小组中的多年经验，他们期待着进一步的协作机会，以应用现有方法以及根据需要适应或开发新方法。