Early Phase Clinical Research Support

早期临床研究支持：项目 总结/摘要 通过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研究者提供了一个 一个全面、高质量的综合平台，以促进和加速评价和发展 将MCC研究项目中有前途的科学发现转化为早期临床试验。最高 优先考虑的是由MCC发动机启动的试验（IIT），这些试验将推进MCC研究中产生的概念 实验室到新的原理证明，可行性，和第一阶段，单剂和合理设计 靶向药物的组合，解决我们患者中出现的肿瘤的分子特征。 癌症中心支持补助金（CCSG）早期资金用于支持临床研究 促进基础科学家和转化科学家之间富有成效的合作所需的基础设施， MCC研究项目及其MCC临床研究同事将创新的新方法转化为 通过实验室研究确定的癌症治疗方法进入试点和I期临床试验。的新概念 这些试验是从研究项目成员中征集的，并由一个明确的、透明的 审查过程由临床研究副主任监督，并由常设IIT概念促进 审查委员会由资深MCC临床、转化和基础科学家组成。于本 在支持期间，EPCRS的资金已被用于促进12个新的MCC领导的开放和进行 实体瘤、恶性血液病和放射治疗中的化疗启动治疗先导性和I期试验 肿瘤学这些试验需要7个IND，在总共281例早期试验中纳入了168例患者（60%）。 应计项目早期临床试验总计281例，占MCC治疗试验总数的33% 855名患者。 MCC IIT导致了药物和药物组合的最大耐受剂量的定义， 已经确定了对适合II期试验的新疗法特别敏感的癌症。优先次序 利用现有的程序进行更多的创新性试点和第一阶段试验，其中6项是 目前正准备启动，另有7个正在开发中。EPCRS基金的支持侧重于试验 解决MCC服务的集水区患者人群未满足的需求，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， 服务不足和少数民族人口在MCC集水区。

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.