Clinical Trial Operations

临床试验运营核心将提供支持临床试验所需的领导和专业知识 该孢子赠款的四个项目的研究。临床试验运营核心将由Dr。 Annick Desjardins和Darell Bigner博士。Desjardins博士将与项目负责人互动，开发临床 根据实验室调查产生的数据进行的试验。临床试验运营核心将 支持孢子临床试验的实际进行，包括提供临床医生、研究经理、研究人员 护士、研究护士从业者、临床试验协调员、监管人员和数据协调员。戴维斯博士。 Desjardins和Bigner将确保临床试验的开发、成功进行和出版 来自四个项目的工作，确保制定所有必要的文件 研究的实施(例如，方案、同意书、IND提交的临床方面、标准操作 程序、监管管理、数据收集和数据发布)。核心B，生物统计学组成部分， 将就实验和临床研究的设计提供建议，包括计算样本量和 能力；数据分析支持(通过在核心内部执行分析或向合格人员提供建议 在项目范围内)，包括使用适当的统计模型和应用统计检验； 必要时，开发新的方法来帮助解释实验结果。此外，一个 生物统计部门成员将参加定期安排的项目会议，以提供 提供统计/生物信息学投入，并协助准备必要的材料，以供介绍和出版。

The Clinical Trial Operations Core will provide the leadership and expertise needed to support the clinical research of the four Projects of this SPORE grant. The Clinical Trial Operations Core will be Co-Directed by Dr. Annick Desjardins and Dr. Darell Bigner. Dr. Desjardins will interact with Project leaders to develop clinical trials based upon the data generated from laboratory investigations. The Clinical Trial Operations Core will support the actual conduct of SPORE clinical trials, including providing clinicians, research manager, research nurses, research nurse practitioner, clinical trial coordinators, regulatory personnel and data coordinators. Drs. Desjardins and Bigner will assure the development, successful conduct, and publication of the clinical trials coming from the work of the four Projects by assuring the development of all the required documents for the conduct of the study (e.g., protocols, consent forms, clinical side of IND submission, standard operating procedures, regulatory management, data collection, and data publication). Core B, 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.