CORE-- Protocol-Specific Research Support

描述（由申请人提供）：目的：支持高质量的创新行为 可行性和I期临床研究方案。服务项目：评估和优先考虑创新的临床研究概念;招募研究参与者;收集，编辑和输入患者数据到计算机中。理由：评估预防、诊断和治疗试验的可行性通常需要分析初步数据，以确定方案和治疗的逻辑可行性和安全性。从试验中获得的信息促进了II期试验的发展，并为随后的赠款提案提供了初步数据。 表1展示了在上一个授权期间PSRS完全或部分支持的协议。从1999年至2002年，支持了60项议定书。截至2002年底， 如表2所示。如表1中粗体字所示，10项研究已导致随访I期或II期试验，无论是活跃的还是开发中的。在表1中，由Eschersks确定的三项研究已经导致了校外资金或赠款提案。例如，98-01-12导致了北中央癌症治疗组的II期试验，以评估这种组合在非霍奇金淋巴瘤中的疗效。Steven Ansell博士已获得R 01资金，以支持试验的实验室组成部分。方案99-01-02提供了导致卵巢癌开发试验的初步数据，并在提交的卵巢SPORE申请中支持Charles Erlichman博士的项目。组织：方案特定研究支持所考虑的每个概念都由疾病或 学科为导向的小组的科学价值和与特定群体的科学目标的一致性。统计学家必须审查拟议的概念，并在研究设计上进行合作。随后，癌症中心支持概念审查委员会（表3）每隔一周召开一次会议，对该概念进行审查。

DESCRIPTION (provided by applicant): Purpose: To support the conduct of high quality innovative feasibility and phase I clinical research protocols. Services: Evaluate and prioritize innovative clinical research concepts; recruit study participants; collect, edit and enter patient data into the computer. Justification: Assessing the feasibility of prevention, diagnosis, and treatment trials often requires the analysis of preliminary data to determine the logistic feasibility and safety of the protocol and treatment. Information gained from the trials promotes the development of phase II trials and generates preliminary data for subsequent grant proposals. Table 1 demonstrates the protocols supported entirely or in part by the PSRS during the previous grant period. 60 protocols were supported from 1999-2002. At the end of 2002, 26 trials were in development as noted in Table 2. As noted by bold type in Table 1, 10 studies have resulted in follow up phase I or II trials either active or in development. The three studies identified by asterisks in Table 1 have resulted in extramural funding or grant proposals. For example, 98-01-12 led to a phase II trial in the North Central Cancer Treatment Group to assess the efficacy of this combination in non-Hodgkin's lymphoma. Dr. Steven Ansell has secured R01 funding to support laboratory components of the trial. Protocol 99-01-02 provided preliminary data leading to a trial in development for ovarian carcinoma and support of Dr. Charles Erlichman's project in a submitted ovarian SPORE application. Organization: Each concept to be considered for Protocol Specific Research Support is reviewed by the disease or discipline oriented group for scientific merit and consistency with the scientific aims of the particular group. A statistician must review the proposed concept and collaborates on study design. Subsequently, the concept is reviewed by the Cancer Center Support Concept Review Committee (Table 3) that meets every other week.