BIOSTATISTICS AND CLINICAL CORE

生物统计学和临床​​核心

• 批准号: 8514331
• 负责人: ANNETTE M MOLINARO
• 金额: $ 16.89万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8514331
• 关键词: Adverse event; Amendment; Bioinformatics; Biological Markers; Biological Products; Biology; Biometry; Brain Neoplasms; Cancer Center; Cancer Therapy Evaluation Program; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Database; Clinical trial protocol document; Data; Data Analyses; Databases; Development; Educational process of instructing; Epidemiology; Evaluation; Future; Grant; Human; Human Resources; Image; Incidence; Individual; Industry; Instruction; Investigation; Laboratories; Lead; Leadership; Maintenance; Methods; Monitor; Nursing Research; Outcome; Patients; Persons; Physicians; Preparation; Principal Investigator; Procedures; Protocols documentation; Publications; Qualifying; Reporting; Reproduction spores; Research; Research Design; Review Committee; Sample Size; Schedule; Site; Specific qualifier value; Statistical Models; Stratification Factors; System; Telephone; Testing; Therapeutic Agents; Tissues; Toxic effect; Translational Research; abstracting; base; chemotherapy; data management; design; follow-up; human subject; improved; meetings; member; novel; novel therapeutics; programs; quality assurance; repository; research study; tool; validation studies

Instnjctions): The Biostatistics and Clinical Core will provide the leadership and expertise needed to support the laboratory and clinical researeh ofthe 4 Projects ofthis SPORE grant. The Clinical component will be led by Dr. Prados, who will interact with Project leaders to develop clinical trials based upon laboratory investigations in Projects Three and Four in particular, as well as to discuss results in Projects One and Two that may lead to relevant biomarkers and potential stratification factors for future or potential clinical trials. The Clinical component will support the actual conduct of SPORE clinical trials, including providing clinicians, research nurses and data coordinators, and assist in all of the required regulatory reporting for those studies. Dr. Prados will support and facilitate the interactions of Project leaders with CTEP, cooperative groups, biopharmaceutical, and industry groups to obtain new therapeutic agents appropriate to the design of new studies that come from Projects Three and Four, as well as supporting the conduct of SPORE clinical trials to those groups as needed. The Biostatistical component wilt be led by Dr. Molinaro, who will interact on an ongoing basis with the individual leaders from all four Projects to assess the statistical needs of each. The Biostatistical component will provide: advice on the design of experimental and clinical studies, including calculating sample sizes and power; data analysis support (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and applications of statistical test; and, when necessary, the development of novel methods to help interpret results from experiments. Additionally, a member of the Biostatistical component will participate in regularly scheduled project meetings to provide statistical/bioinformatics input and assist in preparing the necessary materials for presentation and publication. RELEVANCE (See instructions): The primary aim of a SPORE grant is to support translational research that leads to clinical trials and ultimately improved outcome for patients. This Core will support the efforts of 4 Projects designed to study the biology, incidence, and epidemiology of brain tumors (high grade and low grade) using those results to

指令）： 生物统计学和临床核心将提供支持实验室所需的领导和专业知识 和临床研究。 临床部分将由Prados博士领导，他将与项目负责人互动， 特别是在项目三和四的实验室调查的基础上进行的试验，以及讨论 项目一和项目二的结果可能导致相关的生物标志物和潜在的分层因素 未来或潜在的临床试验。临床部分将支持SPORE临床的实际实施 试验，包括提供临床医生，研究护士和数据协调员，并协助所有必要的 这些研究的监管报告。普拉多斯博士将支持和促进项目的互动 与CTEP、合作团体、生物制药和行业团体的领导者，以获得新的治疗方法， 适合于设计来自项目三和四的新研究的代理人，以及 根据需要支持对这些群体进行SPORE临床试验。 生物统计部分将由Molinaro博士领导，他将与 所有四个项目的个别领导人评估每个项目的统计需求。生物统计部分 将提供：关于实验和临床研究设计的建议，包括计算样本量， 电力;数据分析支持（通过在核心内执行分析或建议合格的 项目内的人员），包括使用适当的统计模型和 统计检验;必要时，开发新的方法来帮助解释 实验此外，生物统计部门的一名成员将参加定期安排的 举行项目会议，提供统计/生物信息学投入，并协助编写必要的材料， 介绍和出版。 相关性（参见说明）： SPORE赠款的主要目的是支持导致临床试验的转化研究， 最终改善患者的预后。该核心将支持4个旨在研究 脑肿瘤（高级别和低级别）的生物学、发病率和流行病学使用这些结果，