clinical research office

罗伯特·H·鲁里综合癌症中心的临床研究办公室(CRO)参与了各级 通过所有附属网络机构启动和开展临床癌症研究。这包括 在拟定议定书、对新议定书进行科学和程序审查、提交初次提交材料方面提供的援助有限 以及对机构审查委员会、临床研究协调和数据收集和 管理，与外部赞助商或内部审查员确保质量，协调生物材料的采购 用于临床/实验室相关性的样本，并协调统计学家和 数据监测委员会。在本报告所述期间(2006年8月1日至7月31日)，有50名调查员使用了这一设施， 其中包括45个有外部资金的国家。这些调查人员来自西北大学内的12个系； 这些研究人员是癌症中心的成员。自2001年以来，每一年内可应计的研究数量 期间为386至449(本期为389)。在这段时间里，所有类型的研究的数量 积极和需要后续行动的信息从862至1040(最近期间为999)不等。总数为4804 8/05-7/06年8月5日至6月7日，受试者参加癌症中心机构的临床试验，其中3996名受试者(83%) 在主要机构注册的有808人(17%)在网络机构注册的人。另有927名受试者在其他 附属网站(经社理事会附属机构、参与当地调查员发起的试验的网站)。在癌症中心的网络站点上， 有666名受试者参加了治疗方案，789名受试者参加了涉及其他干预措施的研究，1025至 流行病学或其他观察性研究，2324项配对、辅助或相关研究。重要的是，4332 在4804名受试者中(90%)，以及666名参加治疗试验的受试者中的382名(57%)是在机构注册的 有内部或外部资金的试验。在本赠款周期内，采取了五项举措：1)继续 我们基于互联网的无纸化方案管理系统和临床试验的开发和增强 管理系统(西北肿瘤试验信息系统-NOTIS)。最近，这项倡议包括 升级系统，以便向我们的癌症中心附属机构推出数据库；2)开展培训 临床工作人员计划和培训手册；3)制定和实施NCI批准的数据和安全 监测计划；4)对办事处的财务结构进行重大审查和重组，从而加强 财务报告；以及5)全面审查控制和修复办公室的议定书启动过程，从而提出建议 将初步议定书审批时间从2004年7月至12月的32周减少到19周 目前。CRO的未来发展将包括将NOTIS扩展到包括电子数据 获取(从主要机构的电子制图资源)用于当地调查员发起的试验，并进一步 对CRO财务跟踪机制的增强，使办公室能够更高效和 准确管理试验的所有财务方面(账单、CRO充值、财务计划等)。

The Clinical Research Office (CRO) of the Robert H. Lurie Comprehensive Cancer Center participates at all levels in the activation and conduct of clinical cancer research conducted through all of the affiliate network institutions. This includes limited assistance with protocol development, scientific and procedural review of new protocols, filing of initial submission and continuing reviews to the institutional review board, clinical research coordination, and data collection and management, assuring quality with outside sponsors or internal reviewers, coordinating procurement of biologic specimens for clinical/ laboratory correlates, and coordinating supervision of appropriate trials by statisticians and the Data Monitoring Committee. In the current reporting period (8/1/05 - 7/31/06) 50 investigators have utilized this facility, including 45 with external funding. These investigators came from 12 departments within Northwestern University; 39 of these investigators are Cancer Center members. Since 2001, the number of studies open to accrual during each 1-year period ranged from 386 to 449 (389 in the current period). During this time the number of studies, of all types, that were active and requiring follow-up information ranged from 862 to 1040 (999 in the most recent period). A total of 4804 subjects were accrued to clinical trials at Cancer Center institutions from 8/05-7/06, including 3996 subjects (83%) enrolled at the main institution and 808 (17%) at network institutions. An additional 927 subjects were enrolled at other affiliated sites (ECOG affiliates, sites participating in local investigator-initiated trials). At Cancer Center network sites, there were 666 subjects enrolled to therapeutic protocols, 789 to studies involving other interventions, 1025 to epidemiologic or other observational studies, and 2324 to companion, ancillary or correlative studies. Importantly, 4332 of the 4804 (90%) total subjects, and 382 of the 666 subjects on therapeutic trials (57%), were enrolled on institutional trials with internal or external funding. During this grant cycle, five initiatives were undertaken: 1) continued development and enhancement of our Internet-based paperless protocol management system and clinical trial management system (Northwestern Oncology Trial Information System-NOTIS). Most recently this initiative has included upgrading the system to allow for roll-out of the database to our Cancer Center affiliates; 2) development of a training program and training manual for clinical staff; 3) development and implementation of a NCI approved Data and Safety Monitoring Plan; 4) significant review and restructuring of the financial structure of the office, resulting in enhanced financial reporting; and 5) a comprehensive review of the CRO's protocol initiation process, resulting in recommendations that have decreased initial protocol approval times from 32 weeks from July-December 2004, to 19 weeks currently. Future developments for the CRO will include expansion of the NOTIS to include electronic data capture (from main institution electronic charting resources) for local investigator-initiated trials, and further enhancements to CRO financial tracking mechanisms that will allow the office to more efficiently and accurately manage all financial aspects of trials (billing, CRO recharges, financial projecting, etc...).