EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-011)

Harold C.西蒙斯癌症中心 早期临床研究支持（EPCRS） 项目总结/摘要 西蒙斯癌症中心的最高优先事项之一是有效地翻译UT西南（UTSW） 科学发现到临床。将这些发现转化为临床益处通常需要临床前 研究以生成支持临床研究所需的初步数据。资助这个临床前 这项工作一直很困难，因为产生初步数据的费用很高， 往往没有外部资金来源。这些包括购买成像时间; PK/PD研究;术前和术后 活检后评估生物标志物;确定临床试验中使用的给药方案;开发 提供功能和代谢信息的新型成像探针。早期阶段干扰器启动 转化研究试验需要大量的监管、数据管理和研究护理资源 传统机制并不总能及时提供这些信息。的首要目标 癌症中心的早期临床研究支持是为癌症中心成员提供支持， 创新的试点或第一阶段研究，以便利用科学领域正在进行的科学研究， 程序.只有研究者发起的方案，基于UTSW科学，并且可能导致 II期或III期研究将获得资助。 2013年，我们通过招募经验丰富的第一阶段负责人亚瑟弗兰克尔来加强我们的第一阶段计划， 医学博士，并提供专门的空间和人员-经理，研究护士和协调员，数据 专家、专门的高级法规助理、行政助理和方案管理员， 促进我们1期活动的扩展，包括药物启动的试验。这一重点导致了一个 所有药物启动的早期阶段试验的应计费用从2009年的47项增加到2013年的231项， 在这些人员的支持下，从8例患者中增加了对促发剂启动的早期研究的招募， 2010年至2013年65。

Harold C. Simmons Cancer Center Early Phase Clinical Research Support (EPCRS) Project Summary/Abstract One of the highest priorities of the Simmons Cancer Center is to effectively translate UT Southwestern (UTSW) scientific discoveries to the clinic. Translating these discoveries into clinical benefit often requires pre-clinical investigations to generate preliminary data needed to support clinical investigation. Funding this preclinical work has been difficult, since there are a number of costs associated with generation of preliminary data which are often unfunded by external sources. These include purchasing of imaging time; PK/PD studies; pre-and post-biopsies to assess biomarkers; determining a dosing regimen to be used in a clinical trial; development of novel imaging probes that provide functional and metabolic information. Early phase investigator-initiated translational research trials require significant regulatory, data management and research nursing resources that are not always available through traditional mechanisms in a timely fashion. The primary goals of the Cancer Center's Early Phase Clinical Research Support is to provide support to Cancer Center members for innovative pilot or Phase I studies, so as to capitalize on the science being carried out in the scientific programs. Only protocols which are investigator initiated, based on UTSW science, and likely to result in Phase II or III studies, will be funded. In 2013, we strengthened our Phase 1 program by recruiting an experienced Phase 1 Leader, Arthur Frankel, M.D., and provided dedicated space and personnel — a manager, research nurse and coordinators, data specialists, a dedicated senior regulatory associate, an administrative assistant and a protocol administrator to facilitate expansion of our phase 1 activities including investigator-initiated trials. This focus has led to an overall increase in accrual to all investigator-initiated early phase trials from 47 in 2009 to 231 in 2013, with an increase in accrual to investigator-initiated early phase studies supported by these personnel from 8 patients in 2010 to 65 in 2013.