Integrated Assessment of Novel Therapies in Oncology

描述（由申请人提供）：这项K24资助申请旨在为首席研究员提供支持，并指导受训者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。在过去的5年里，这项拨款所取得的主要成就包括：1)将我的研究经费来源从1998年100%的工业和机构支持转变为2003年85%的工业和15%的工业支持；2)将范德比尔特大学第一阶段项目的研究活动增加一倍，并于2003年3月与NCI签订了第一阶段U01合作协议；3)在115例接受吉非替尼治疗的转移性结直肠癌患者中，领导一项将肿瘤前和肿瘤后活检中EGFR信号通路的生物学变化与临床结果相关联的全国性II期试验；4) 2002年9月，在NCI资助的胃肠癌范德比尔特孢子P50项目中领导临床转化研究工作；5)担任旨在培养对临床转化研究感兴趣的年轻研究人员职业生涯的国家项目的教师，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；并在范德比尔特大学教授和指导从事以病人为导向的临床研究的研究员和初级教员。这些成就既证明了K24拨款机制的成功，也证明了我有能力以符合其预期用途的方式申请这笔拨款的支持。虽然已经取得了许多成就，但仍有许多工作要做。我相信通过K24奖的持续支持将对我的努力至关重要，1)进行整合新技术的实验室-临床研究，包括药物遗传学，药物基因组学，流言基因组学和蛋白质组学表征，作为新抗癌药物早期临床评估的一部分；2)继续培养年轻研究人员成为早期药物开发的转化研究人员；3)允许首席研究员有足够的保护时间继续扩大与以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.