Biostatistics Core

生物统计学核心

• 批准号: 10006071
• 负责人: Alexia E Iasonos
• 金额: $ 2.72万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006071
• 关键词: Advisory Committees; Animals; Appointment; Area; Biometry; Biostatistics Core; Cell Line; Chemotherapy-Oncologic Procedure; Clinical; Clinical Research; Clinical Trials; Collaborations; Computers; Data Analyses; Data Quality; Databases; Disease; Dose; Experimental Designs; Faculty; Formulation; Funding; Future; Genomics; Grant; Gynecologic; Gynecology; Immunologics; In Vitro; Investigation; Investigational Therapies; Laboratory Study; Lead; Letters; Malignant neoplasm of ovary; Manuscripts; Master' s Degree; Memorial Sloan-Kettering Cancer Center; Methodology; Molecular Epidemiology; Monitor; Oncologist; Ovarian; Pathologist; Patients; Phase; Population; Program Research Project Grants; Protocols documentation; Reporting; Research; Research Personnel; Role; Sample Size; Services; Site; Statistical Data Interpretation; Surgeon; Tumor Biology; Universities; Work; Writing; anticancer research; design; experimental study; gene therapy; in vivo; laboratory experiment; medical schools; member; novel therapeutics; pre-clinical; primary endpoint; primary outcome; programs; secondary endpoint; secondary outcome; trial design

PROJECT SUMMARY The biostatistics core will support all statistical analyses and design of experiments for the Program project application entitled “Immunologic Approaches to Ovarian Cancer” lead by Dr Spriggs. The role of the biostatistics core is to support the investigators of the Program Project (P01) in Ovarian Cancer in their research efforts, including designing and analyzing in-vivo and in-vitro experiments, tumor biology studies, and clinical trials. In all studies, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. In the design phase, a core member will collaborate with the investigators in outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a trial design and a protocol review if necessary, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the experiment, data analyses will be performed to assess outcomes of the primary and secondary aims as stated in the P01 application. The molecular epidemiology of ovarian cancer will be investigated using array experiments, experiments in cell lines, animals and patients. The specific aims of the biostatistics core are the following: 1) Contribute to the design and analysis of laboratory studies, tumor biology studies, and clinical trials in ovarian cancer research. 2) Assist investigators in assembling study databases, monitoring data quality, and reviewing the adequacy of design assumptions. 3) Prepare reports for the internal and external advisory committees. 4) Write project manuscripts in collaboration with project investigators. 5) Suggest analysis and design strategies for future studies.6) Develop statistical methodology that will assist in the advancement of ovarian cancer research. Dr. Iasonos will be the director of the Biostatistics Core and she will be responsible for the design and analysis of clinical experiments. She will complete this task with the assistance of Ms Zhou who has been working with oncologists, surgeons and pathologists from the Gynecologic service since 2006. Dr. Seshan who is currently the Director of Biostatistics Computer-Intensive Support Services will provide an advisory role since he has been a co-director of the Core for the Ovarian P01 for the past 15 years. Finally, the core will utilize the Biostatistics Service at Memorial Sloan Kettering Cancer Center (MSKCC). The Service consists currently of 35 biostatisticians, 19 of them with professional staff appointments and 16 with masters degrees and research appointments.

项目摘要 生物统计学核心将支持该计划项目的所有统计分析和实验设计 Spriggs博士领导的名为“卵巢癌免疫方法”的应用。角色 生物统计学的核心是为卵巢癌的计划项目（P01）的研究人员提供支持 研究工作，包括设计和分析体内和体外实验，肿瘤生物学研究以及 临床试验。在所有研究中，核心成员将协助实验设计和 研究结束时数据的分析和解释。在设计阶段，核心成员将 与研究人员合作概述了主要的科学目标，人口是研究，主要和 次要终点，实验设计，试验设计和必要的协议审查，分析计划， 以及针对概率术语合理的目标样本量。实验结束时，数据分析 如P01应用程序中所述，将进行评估主要和次要目标的结果。这 卵巢癌的分子流行病学将使用阵列实验，在细胞中进行实验研究 线条，动物和患者。生物统计学核心的具体目的是：1）有助于 实验室研究，肿瘤生物学研究以及卵巢癌研究的临床试验的设计和分析。 2）协助调查人员组装研究数据库，监视数据质量并审查是否充分 设计假设。 3）准备内部和外部咨询委员会的报告。 4）写项目 手稿与项目调查人员合作。 5）建议未来的分析和设计策略 研究。6）开发统计方法，将有助于进步卵巢癌研究。博士 Iasonos将担任生物统计学核心的主任，她将负责设计和分析 临床实验。她将在与之合作的周的协助下完成这项任务 自2006年以来 生物统计学计算机密集型支持服务总监将提供咨询角色，因为他 在过去的15年中，是卵巢P01的核心联合导演。最后，核心将利用 纪念斯隆·凯特林癌症中心（MSKCC）的生物统计服务。该服务目前由 35名生物统计学家，其中19位接受了专业员工的任命和16个硕士学位和研究 约会。