C3/C: Clinical Trials and Advocacy Core

。 临床试验和宣传核心为成功推进 我们的孢子翻译研究项目。除了支持现有的孢子临床试验外， 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，他们 希望为孢子贡献换位的概念。患者权益倡导者的积极参与 试验设计和应计策略代表了临床试验和宣传核心的一个独特方面。这个 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以 迅速设计、启动和监测经修订的续展申请中提议的四个试验/项目。这个 主任和联席主任将监督人事和学习管理的各个方面，并将协助 新的转化性/干预性研究所需的持续监管流程涉及多个 孢子内外的机构。2.为初级教员提供临床洞察力和指导 和实验室科学家接受孢子试验和职业发展资金，以帮助撰写试验 并在监管和赞助障碍方面提供适当的援助，以更快地发展 下一代转化型前列腺癌临床试验。3.支持我们的宣传/推广 协助临床试验开发和患者积累的计划，充当大使 在孢子和各种患者权益倡导者之间，并监督社区外展 活动。这些目标将通过核心会议、孢子调查员会议、 与生物统计/生物信息学核心的会议，与个人调查人员的会议，社区 外展活动和出席全国孢子会议。

. 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.