Early Phase Clinical Research Support

早期临床研究支持：项目 摘要/摘要 由弗吉尼亚联邦大学梅西癌症中心(MCC)临床试验办公室进行 (CTO)，早期临床研究支持(EPCRS)计划为MCC研究人员提供 全面、高质量、一体化平台，促进和加快评估发展 从MCC研究计划到早期临床试验的有希望的科学发现。最高值 优先考虑由MCC研究人员发起的试验(IIT)，这些试验提出了来自MCC研究的概念 实验室进入新的原理证明、可行性和第一阶段，单剂和合理设计 针对我们患者肿瘤的分子特征的靶向药物组合。 癌症中心支持赠款(CCSG)的早期资金用于支持临床研究 促进基础科学家和翻译科学家之间富有成效的合作所需的基础设施 MCC研究计划及其MCC临床研究同事将创新的新方法转化为 癌症治疗是通过实验室研究进入试点和I期临床试验确定的。新的概念 这些试验是从研究计划成员那里征求的，并由定义明确和透明的 由临床研究副主任监督并由常设IIT概念促进的审查过程 由资深MCC临床、翻译和基础科学家组成的审查委员会。在当前的 在支助期内，EPCRS资金已用于促进12个由MCC牵头的新项目的开幕和开展 研究人员发起的实体肿瘤、血液系统恶性肿瘤和放射治疗的试点和I期试验 肿瘤学。这些试验需要7个IND，在全部281名早期患者中，有168名患者(60%)获得了成功 应计项目。总计281项早期临床试验占MCC治疗试验总数的33% 累计治疗855例患者。 MCC研究所已确定了药物和药物组合的最大耐受剂量，并 已经确定癌症对适合第二阶段试验的新疗法特别敏感。确定优先顺序 已到位的流程用于进行额外的创新试点和第一阶段试验，其中6项是 目前准备启动，另有7个正在开发中。EPCRS基金的支持集中在试验上 解决MCC服务的集水区病人未得到满足的需求，并支持 NIH/NCI的使命是为大部分地区的患者提供早期临床试验 MCC集水区的服务不足和少数民族人口。

EARLY-PHASE CLINICAL RESEARCH SUPPORT: PROJECT SUMMARY/ABSTRACT Conducted through the Virginia Commonwealth University Massey Cancer Center (MCC) Clinical Trials Office (CTO), the Early-Phase Clinical Research Support (EPCRS) program provides MCC investigators with a comprehensive, high-quality, integrated platform to facilitate and accelerate the evaluation and development of promising scientific discoveries from the MCC research programs into early-phase clinical trials. Highest priority is given to MCC investigator-initiated trials (IITs) that advance concepts arising from MCC research laboratories into novel proof-of-principle, feasibility, and phase I, single-agent and rationally designed combinations of targeted agents that address the molecular signatures of tumors arising in our patients. Cancer Center Support Grant (CCSG) early-phase funds are used to support the clinical research infrastructure required to promote productive collaborations between basic and translational scientists in the MCC research programs and their MCC clinical research colleagues to translate innovative new approaches to cancer treatment identified through laboratory research into pilot and phase I clinical trials. New concepts for these trials are solicited from research program members and are prioritized by a well-defined and transparent review process overseen by the associate director of clinical research and facilitated by a standing IIT Concept Review Committee composed of senior MCC clinical, translational, and basic scientists. During the current period of support, EPCRS funds have been used to facilitate the opening and conduct of 12 new MCC-led investigator-initiated treatment pilot and phase I trials in solid tumors, hematologic malignancies and radiation oncology. These trials, which required 7 INDs, accrued 168 patients (60%) of the total 281 early-phase accruals. Total early-phase clinical trial local accrual of 281 accounted for 33% of the total MCC treatment trial accrual of 855 patients. MCC IITs have resulted in the definition of maximum tolerated doses for drugs and drug combinations and have identified cancers particularly sensitive to novel therapies suitable for phase II trials. The prioritization process in place is used to pursue a pipeline of additional innovative pilot and phase I trials, of which 6 are currently poised for initiation, with another 7 under development. Support from EPCRS funds focuses on trials addressing the unmet needs of the patient population in the catchment area served by MCC and support the mission of the NIH/NCI by providing access to early-phase clinical trials to patients within the largely underserved and minority populations in the MCC catchment area.