CB: Clinical Trials and Biostatistics Core

这一核心的中心目标是：a)以合乎道德和科学严谨的方式进行临床试验；b)促进 目前正在进行的或正在开发的临床试验和该孢子的项目的整合； C)支持临床试验的实施以及患者登记、数据收集和 满足与作为该孢子一部分的试验以及新的临床试验相关的法规要求 利用该孢子产生的分子知识；D)促进 将新的治疗药物纳入该孢子的总体研究目标；E)参与(与核心A) 有效和准确地将数据电脑化所需的数据库结构的设计 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)实时监测项目积累的数据，确定 潜在的问题，并酌情与项目负责人讨论，并启动补救行动 必要时；g)确保所有机构和联邦监管要求都是最佳的 及时地得到满足。H)提供统计专门知识，协助调查人员规划 研究性研究，包括关于基本研究设计的决定以及研究参数，如样本 观察的规模、应计和后续时间以及频率；i)进行统计分析和 按照项目研究方案的要求编制数据摘要，并协助解释 成果；j)协助编写将传播知识的摘要和手稿 通过这种孢子感染了整个医学界。这个核心将由乔治博士共同领导 西蒙，胸科肿瘤学项目的经验丰富的内科研究员和迈克尔·谢尔博士， 莫菲特癌症中心生物统计核心科学主任，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 癌症和杰罗德·贝普勒博士是这个孢子的私家侦探，这些调查人员有一个漫长的和 既往临床调查和统计分析的生产史。西蒙博士将把注意力集中在 临床试验后勤问题，如研究方案的准备、患者的登记和保留，以及 满足法规要求，监督临床试验协调员，成为 个别项目负责人实施其临床试验，并准备和回应 癌症中心要求进行审计。此外，他将与贝普勒博士一起构思新的研究 使用孢子项目产生的新知识。Schell博士将专注于统计设计 孢子研究；以及制作统计分析和摘要。贝普勒博士将提供咨询 在必要的基础上提供给这个核心的调查者

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