PROTOCOL SPECIFIC RESEARCH SUPPORT

描述（由申请人提供）：方案特定研究支持的总体目标是促进癌症中心教职员工开展新型治疗试验，并为缺乏校外支持的高优先级癌症中心制药商发起的临床试验提供研究护理和数据管理支持。 核心补助金机构临床试验支持代表了一个必不可少的资助机制，为制药商发起的转化研究工作。 来自核心补助金的方案特定研究支持对于临床研究的发展至关重要，并在多种情况下提供资金，包括在概念开发的早期，可能需要初步数据以获得外部同行评审资金，以及启动被其他机制视为“高风险”的调查路线。 当癌症中心成员撰写的方案提交给 方案审查和监测系统（PRMS）委员会，研究者可以选择 如果他/她没有提供护理和数据管理的资金来源，并且他/她认为试验具有很高的科学价值，则请求核心补助金支持。 在PRMS委员会会议之前，委员会主席确认临床方案和数据管理（CPDM）机构管理员没有提供护理/数据管理支持;委员会审查包括委员会对中心主任核心补助金支持的建议。 使用的标准包括高科学价值（1 - 5评分系统<2.0），研究的转化性质和癌症中心PRMS委员会审查的优先领域。 此类试验的最终批准由中心主任负责。自上一个资助期以来，已有14项研究通过这一机制获得资助，这些研究累积了325例患者（共4年）。 这一总应计费用和应计费用/年（81）超过了我们的目标33%（60应计费用/年）。在下一个资助期间，我们将继续扩大我们的制药商发起的临床试验计划。 随着当前和已完成的临床试验的令人印象深刻的组合，以及我们越来越多的临床研究者，我们预计这些研究者将继续需要核心补助金的支持，以启动新的试验，并提高他们竞争校外资金的能力。 临床研究者与我们的微阵列实验室、药理学/药代动力学实验室、成像资源和临床前科学家的合作将增强我们进行具有有意义生物学终点的转化研究的能力。 血液肿瘤科 诊所将从8,000平方英尺扩大到13,000平方英尺。 其中包括新的门诊研究设施，设有针对特定疾病的第一阶段研究诊所，将于2004年7月投入使用。

DESCRIPTION (provided by applicant): The overall goals of the Protocol Specific Research Support are to promote the conduct of novel therapeutic trials by Cancer Center Faculty and to provide research nursing and data management support for high priority Cancer Center investigator-initiated clinical trials that lack extramural support. The Core grant institutional clinical trials support represents an essential funding mechanism for investigator-initiated translational research efforts. Protocol Specific Research Support from the Core grant is critical to development of clinical research and provides funding in multiple situations including early in the development of a concept when preliminary data may be required to obtain extramural peer reviewed funding and initiation of lines of investigation regarded as "high risk" by other mechanisms. When protocols written by Cancer Center members are submitted to the Protocol Review and Monitoring System (PRMS) Committee, the investigator has the option to request Core grant support if he/she does not have a source of funds to provide nursing and data management and he/she feels that the trial has high scientific merit. Prior to the PRMS Committee meeting, the Chairman of the Committee confirms the absence of nursing/data management support from the Clinical Protocol and Data Management (CPDM) Facility administrator; the committee review includes a committee recommendation on Core grant support to the Center Director. The criteria used include high scientific merit (<2.0 on a 1-5 scoring system), translational nature of the study and a priority area of the Cancer Center's PRMS Committee review. The final approval on such trials rests with the Center Director. Since the last funding period 14 studies have received funding through this mechanism and these studies have accrued 325 patients (4 year total). This total accrual and accrual/year (81) has exceeded our target by 33% (60 accruals/year). During the next funding period, we will continue to expand our investigator-initiated clinical trials program. With the impressive portfolio of current and completed investigator-initiated trials and our increased number of clinical investigators we expect these investigators will continue to require support from the Core grant to initiate new trials and enhance their ability to compete for extramural funds. Collaboration of clinical investigators with our micro-array laboratory, pharmacology/pharmacokinetics laboratory, imaging resources and pre-clinical scientists will enhance our ability to undertake translational studies with meaningful biologic endpoints. The Hematology-Oncology Unit in The Kirklin Clinic is being expanded from 8,000 to 13,000 ft2. Included is the new outpatient research facility, with its disease-specific and phase I research clinics and will be operational in July 2004.