Integrated Assessment of Novel Therapies in Oncology

描述(申请人提供)：这份K24拨款申请旨在继续支持首席研究人员进行和指导受训人员进行以患者为导向的临床研究，将早期临床试验与实验室相关研究联系起来。这笔赠款在过去5年中取得的主要成就包括：1)将我的研究资金来源从1998年的100%行业和机构支持转移到2003年的85%和15%行业；2)范德比尔特第一阶段计划的研究活动增加了一倍，最终在2003年3月获得了NCI的第一阶段U01合作协议；3)领导了一项全国性的第二阶段试验，将肿瘤前后活检中EGFR信号通路的生物学变化与使用Gefitinib治疗的115名转移性结直肠癌患者的临床结果联系起来；4)领导胃肠道癌症范德比尔特孢子P50基金的临床-翻译研究工作；5)担任国家项目的教职员工，这些项目旨在促进对临床-翻译研究感兴趣的年轻研究人员的职业生涯，包括ASCO/AACR临床癌症研究方法研讨会、安进研究员联盟和ASCO年会的研究员教育会议；以及6)在Vanderbilt继续从事以患者为导向的临床研究的教学和指导研究员和初级教员。这些成就既证明了K24赠款机制的成功，也证明了我有能力以与预期用途一致的方式应用这笔赠款的资助。尽管已经取得了很大成就，但仍有很多工作要做。我相信，通过K24奖项的持续支持对我的努力将是至关重要的，1)进行实验室-临床综合研究，纳入新技术，包括药物遗传学、药物基因组、肿瘤基因组和蛋白质组表征，作为新抗癌药物早期临床评估的一部分；2)继续培训年轻研究人员，使其成为早期药物开发的转化性研究人员；以及3)允许首席研究人员有足够的保护时间，继续扩大与患者为导向的临床研究相关的教育活动。

DESCRIPTION (provided by applicant): This K24 grant application seeks to renew support for the principal investigator to conduct and to mentor trainees in the conduct of patient-oriented clinical research bridging early phase clinical trials with laboratory correlative studies. Key accomplishments made possible by this grant over the past 5 years include, 1) shifting the sources of my research funding from 100% industry and institutional support in 1998 to 85% NTH and 15% industry in 2003; 2) doubling the research activities of the Phase I Program at Vanderbilt, culminating in the award of a Phase I U01 cooperative agreement from NCI in March, 2003; 3) leading a national Phase II trial correlating biological changes in the EGFR signaling pathway in pre- and post-tumor biopsies with clinical outcome in 115 patients with metastatic colorectal cancer treated with gefitinib; 4) leading the clinical-translational research effort in the Vanderbilt SPORE in Gastrointestinal Cancer P50 grant funded by NCI September, 2002; 5) serving on the faculty of national programs designed to foster the careers of young investigators interested in careers in clinical-translational research including the ASCO/AACR Workshop on Methods in Clinical Cancer Research, the Amgen Fellows Alliance, and the Fellows Educational Session of the ASCO annual meeting; and 6) teaching and mentoring fellows and junior faculty at Vanderbilt who have gone on to careers in patient-oriented clinical research. These achievements attest to both the success of the K24 grant mechanism and to my abilities to apply the support from this grant in a fashion consistent with its intended uses. Although much has been accomplished, there is still much to do. I believe that continued support through this K24 award will be essential in my efforts to, 1) perform integrated laboratory-clinical studies that incorporate new technologies, including pharmacogenetic, pharmacogenomic, rumor genomic, and proteomic characterization as part of early phase clinical evaluation of new anticancer agents; 2) to continue to train young investigators to become translational researchers in early phase drug development; and 3) allow the principal investigator sufficient protected time to continue to expand educational activities related to patient-oriented clinical research.