C3/C: Clinical Trials and Advocacy Core

点击翻译按钮获取中文摘要

. 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.