CORE-- Protocol-Specific Research Support

描述(申请人提供)：目的：支持进行高质量的创新 可行性和I期临床研究方案。服务：评估创新的临床研究概念并确定优先顺序；招募研究参与者；收集、编辑患者数据并将其输入计算机。合理性：评估预防、诊断和治疗试验的可行性通常需要对初步数据进行分析，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第二阶段试验的发展，并为随后的赠款提案产生了初步数据。 表1显示了在前一个授权期内PSR完全或部分支持的协议。从1999-2002年间支持了60项协议。在2002年底，26项审判正在进行中。 如表1中粗体字所示，已有10项研究产生了后续的第一或第二阶段试验，这些试验正在进行或正在开发中。表1中用星号标出的三项研究产生了外部资金或赠款提案。例如，98-01-12导致了北中癌症治疗组的II期试验，以评估这种联合治疗非霍奇金淋巴瘤的疗效。史蒂文·安塞尔博士已经获得了R01资金，以支持该试验的实验室部分。协议99-01-02提供了初步数据，导致了卵巢癌的开发试验，并在提交的卵巢孢子申请中支持了Charles Erlichman博士的项目。组织：考虑用于方案特定研究支持的每个概念都由疾病或 以学科为导向的群体，追求科学价值，并与特定群体的科学目标保持一致。统计学家必须审查提出的概念，并在研究设计上进行合作。随后，每隔一周召开一次会议的癌症中心支持概念审查委员会(表3)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.