CB: Clinical Trials and Biostatistics Core

CB：临床试验和生物统计学核心

• 批准号: 7923285
• 负责人: GEORGE R., SIMON
• 金额: $ 34.69万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 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/7923285
• 关键词: Attention; Biostatistics Core; Cancer Center; Clinical; Clinical Trials; Communities; Community Clinical Oncology Program; Conduct Clinical Trials; Consultations; Data; Data Analyses; Data Collection; Development; Enrollment; Ensure; Ethics; Frequencies; Goals; Individual; Investigation; Knowledge; Logistics; Malignant Neoplasms; Malignant neoplasm of lung; Manuscripts; Medical; Molecular; Monitor; Participant; Patients; Physicians; Preparation; Privacy; Process; Production; Protocols documentation; Recording of previous events; Reproduction spores; Research; Research Design; Research Personnel; Resources; Sample Size; Therapeutic Agents; Thoracic Oncology; Time; Work; abstracting; base; database structure; design; experience; follow-up; novel therapeutics; research clinical testing; research study; satisfaction

The central goals of this core are: A) ethical and scientifically rigorous conduct of clinical trials; B) facilitate the integration of clinical trials that are currently ongoing, or are in development, and projects of this SPORE; C) to support the implementation of clinical trials and the process of patient enrollment, data collection, and satisfy regulatory requirements associated with trials that are part of this SPORE as well as new clinical trials that take advantage of molecular knowledge generated by this SPORE; D) to facilitate the integration of novel therapeutic agents into the overall research goal of this SPORE; E) to participate (with Core A) in design of the database structures necessary for the efficient and accurate computerization of data for the studies in each project; and to do this in a manner that protects participants' privacy and protects against data loss and/or corruption; F) to monitor the projects' data in real time as they are accumulated, identifying potential problems, and discussing them with the project leaders as appropriate and initiating remedial action when necessary; G) To ensure that all institutional and federal regulatory requirements are optimally satisfied in a timely manner. H) to provide the statistical expertise to assist investigators in the planning of research studies, including decisions on the basic study design as well as study parameters such as sample size, accrual and follow-up time, and frequency of observations; I) to perform the statistical analyses and produce data summaries as called for in the projects' study protocols, and to facilitate interpretation of results; J) to assist in the preparation of abstracts and manuscripts that will disseminate the knowledge gained through this SPORE throughout the medical community. This Core will be led jointly by Dr. George Simon, an experienced physician-researcher in the Thoracic Oncology Program and Dr. Michael Schell, the Scientific Director of the Biostatistics Core at the Moffitt Cancer Center, also an experienced biostatistician especially as pertaining to the design and conduct of cancer clinical trials, with special emphasis on lung cancer and Dr. Gerold Bepler who is the P.I. of this SPORE These investigators have a lengthy and productive history of prior clinical investigations and statistical analyses. Dr. Simon will focus his attention on issues of clinical trial logistics such as preparation of study protocols, patient enrollment and retention, and satisfaction of regulatory requirements, supervise the clinical trials coordinators, be a resource to the individual project leaders in the implementation of their clinical trials and prepare for and respond to the Cancer Center mandated audits. In addition, he along with Dr. Bepler will conceptualize new studies that use the new knowledge generated by the SPORE's projects. Dr. Schell will focus on statistical design of SPORE studies; and production of statistical analyses and summaries. Dr. Bepler will provide consultations on an as needed basis to the investigators of this core

该核心的中心目标是：A）伦理和科学严谨的临床试验; B）促进 整合目前正在进行或正在开发的临床试验以及该SPORE的项目; C）支持临床试验的实施和患者入组、数据收集的过程，以及 满足与作为本SPORE一部分的试验以及新的临床试验相关的监管要求 利用该孢子产生的分子知识; D）促进整合 新的治疗药物纳入本SPORE的总体研究目标; E）参与（与核心A） 设计必要的数据库结构，以便有效和准确地将 在每个项目中进行研究;并以保护参与者隐私和防止 数据丢失和/或损坏; F）在项目数据积累时真实的监控， 潜在的问题，并酌情与项目负责人讨论这些问题，并采取补救措施 G）确保所有机构和联邦监管要求都是最佳的 及时满足。H）提供统计专业知识，协助调查人员规划 研究，包括基本研究设计以及研究参数（如样本）的决定 规模、招募和随访时间以及观察频率; I）进行统计分析， 根据项目研究方案的要求，编制数据摘要，并便于解释 J）协助编写将传播知识的摘要和手稿 通过这个孢子在整个医学界获得。该核心将由乔治博士 Simon博士是胸部肿瘤学项目中经验丰富的医生兼研究员， Moffitt癌症中心生物统计学核心的科学总监，也是一位经验丰富的生物统计学家 特别是关于癌症临床试验的设计和实施，特别强调肺癌 癌症和私家侦探格罗尔德·贝普勒博士这些调查人员有一个漫长的， 既往临床研究和统计分析的生产历史。西蒙医生会集中精力 临床试验后勤问题，如研究方案的准备、患者入组和保留，以及 满足监管要求，监督临床试验协调员，成为 个人项目负责人在实施其临床试验，并准备和应对 癌症中心授权审计。此外，他沿着贝普勒博士将概念化新的研究， 使用由SPORE项目产生的新知识。Schell博士将专注于统计设计， SPORE研究;以及统计分析和摘要的制作。Bepler博士将提供咨询 根据需要向本中心的研究人员提供