C3/C: Clinical Trials and Advocacy Core

. 临床试验和倡导核心为成功推进 我们的SPORE转化研究项目。除了支持现有的SPORE临床试验外， Core将设计和完成临床试验的专业知识带给其他实验室研究人员， 我希望能为SPORE贡献一些透明的概念。患者积极参与， 试验设计和应计策略代表了临床试验和倡导核心的一个独特方面。的 临床试验和宣传核心有3个具体目标：1。开发临床试验资源核心， 快速设计、启动和监测修订后的延期申请中提议的四项试验/项目。的 主任和联席主任将监督人事和研究管理的所有方面，并将协助 多项新型转化/干预性研究所需的持续监管流程 无论是内部还是外部的机构。2.为初级教师提供临床见解和指导 实验室科学家获得SPORE试点和职业发展资金，以帮助撰写试验 并提供适当的援助，以克服监管和赞助障碍， 下一代转化前列腺癌临床试验。3.支持我们的宣传/推广 协助临床试验开发和增加患者的计划，作为大使发挥作用 在SPORE和各种患者倡导选区之间，并监督社区外展 活动这些目标将通过核心会议、SPORE研究者会议、 与生物统计学/生物信息学核心的会议，与个体研究者的会议，社区 外展活动和出席国家孢子会议。

. The Clinical Trials and Advocacy Core provides a much needed resource for the successful advancement of our SPORE translational research projects. In addition to supporting the existing SPORE clinical trials, the Core brings the expertise of designing and completing clinical trials to other laboratory investigators who wish to contribute transtational concepts to the SPORE. The active participation of the patient advocates in trial design and accrual strategies represents a unique aspect of the Clinical Trials and Advocacy Core. The Clinical Trials and Advocacy Core has 3 specific aims: 1. To develop a Clinical Trials Resource Core to rapidly design, activate and monitor the four trials/projects proposed in the revised renewal application. The Director and Co-Directors will supervise all aspects of personnel and study management and will assist in the ongoing regulatory processes required for novel translational/interventional studies across multiple institutions within and outside of the SPORE. 2. To provide clinical insight and mentorship to junior faculty and laboratory scientists receiving SPORE pilot and career development funding to aid in the writing of trials and to provide appropriate assistance with regulatory and sponsorship hurdles to more rapidly develop the next generation of translational prostate cancer clinical trials. 3. To support ourAdvocacy/Outreach Program that assists with clinical trial development and accrual of patients, functions as ambassador between the SPORE and various patient advocacy constituencies, and oversees community outreach activities. These goals will be accomplished through meetings of the Core, SPORE investigator meetings, meetings with the Biostatistics/Bioinformatics Core, meetings with individual investigators, community outreach activities and attendance at the National SPORE meetings.