Protocol Specific Research Support

概述 目的和目标 该资源的目标是通过专门为这些试验的管理提供经验丰富的研究护理和数据管理支持，来支持越来越多的高质量，创新，制药商发起的早期临床试验。这种研究支持的可用性对于具有高度复杂性、对样本的高需求和/或对患者监测和互动需求增加的试验至关重要。进入这些主要是I期或I/II期试验的患者将 越来越需要专门的研究护理，以确保：1）所有的同意都是特别知情的; 2）所有的不良事件都被检测到; 3）所有必要的样本都在适当的时间获得，并进行迅速和仔细的处理; 4）与患者的反馈保持在最佳水平。利用该设施的研究者将获得癌症中心共享资源进行组织和遗传分析，使没有自己实验室的临床研究者能够启动包括相关研究在内的由研究者发起的方案。 理由 斯坦福大学的发展治疗学小组及其在分子治疗学项目中的活动一直在扩大。未来五年的愿景是使建立在斯坦福大学科学基础上的早期临床/转化研究成为癌症中心的最高优先级。将于2012年完成的弗里蒙特里奇转化研究中心将致力于这一使命 并将在一个地点为病人治疗、研究护理支持和数据管理提供综合空间。这种物理上的接近，加上Sikic博士（临床研究副总监; 05：治疗学）的领导力和最近预期的转化医学和I/II期试验能力领域的招聘，将为早期癌症临床试验项目的扩展提供理想的环境。

Overview Goal and Objectives The goal of this resource is to support an increasing number of high quality, innovative, investigator-initiated early-phase clinical trials by providing experienced research nursing and data management support exclusively for the management of these trials. The availability of this research support is essential for trials that have high levels of complexity, high demand for specimens, and/or increased need for patient surveillance and interactions. Patients entered onto these predominantly Phase I or Phase I/II trials will have increased need for specialized research nursing to insure that 1) all consent is particularly well informed; 2) all adverse events are detected; 3) all requisite samples are obtained at the appropriate time and with expeditious and careful processing; and 4) feedback to and from the patients is maintained at an optimal level. Investigators making use of this facility will have the availability of the Cancer Center Shared Resources for tissue and genetic analyses, enabling clinical investigators without their own laboratories to initiate investigator-initiated protocols that include correlative studies. Rationale Stanford's Developmental Therapeutics group and their activities within the Molecular Therapeutics Program have been expanding. The vision over the next five years is to make early-phase clinical/translational research built on Stanford science the highest priority of the Cancer Center. The Freidenrich Center for Translational Research, to be completed in 2012, will be dedicated to this mission and will provide integrated space for patient treatment, research nursing support, and data management in a single location. This physical proximity, together with Dr. Sikic's (Associate Director Clinical Research; 05: Therapeutics) leadership and recent, anticipated recruitments in the areas of translational medicine and Phase I/II trial capability, will provide an ideal environment for the expansion of the early phase cancer clinical trial program.