clinical research office

临床研究办公室

• 批准号: 8309432
• 负责人: TIMOTHY M KUZEL
• 金额: $ 45.44万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8309432
• 关键词: Adherence; Ancillary Study; Budgets; Cancer Center; Charge; Chemoprevention; Chicago; Child; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Companions; Comprehensive Cancer Center; Contracts; Correlative Study; Cost Analysis; Critiques; Data; Data Collection; Databases; Development; Eastern Cooperative Oncology Group; Electronics; Eligibility Determination; Enrollment; Ensure; Epidemiology; Evaluation; Funding; Future; Grant; Guidelines; Healthcare; Hematology; Hospitals; Information Systems; Institutes; Institution; Institutional Review Boards; Internet; Intervention; Laboratories; Malignant - descriptor; Malignant Neoplasms; Manuals; Medical Oncology; Medical center; Monitor; Observational Study; Procedures; Process; Protocols documentation; Radiation Oncology; Recommendation; Rehabilitation therapy; Reporting; Research; Research Personnel; Research Proposals; Resources; Safety; Site; Specimen; Structure; Supervision; Surgical Oncology; System; Therapeutic; Therapy Clinical Trials; Time; Training; Training Programs; Universities; Work; anticancer research; base; data management; electronic data; follow-up; human subject protection; meetings; member; neuro-oncology; oncology; protocol development; quality assurance; response

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...).

临床研究办公室（CRO）的罗伯特H。Lurie综合癌症中心参与各级 通过所有附属网络机构启动和开展临床癌症研究。这包括 对方案制定、新方案的科学和程序审查、初次提交的存档提供有限协助 并向机构审查委员会、临床研究协调和数据收集进行持续审查， 管理，与外部申办者或内部审查人员一起确保质量，协调生物制剂的采购 用于临床/实验室相关的样本，并协调统计学家和 数据监测委员会。在本报告所述期间（2005年8月1日至2006年7月31日），50名调查员使用了这一设施， 其中45人获得外部资助。这些研究人员来自西北大学的12个系; 这些研究者都是癌症中心的成员自2001年以来，每1年开放累积的研究数量 报告所述期间的人数从386人到449人不等（本期为389人）。在此期间，所有类型的研究数量， 积极和需要后续信息的病例从862例到1 040例不等（最近一个时期为999例）。共4804个 2005年8月至2006年7月，癌症中心机构的临床试验招募了3996例受试者（83%） 808人（17%）在主要机构注册，808人（17%）在网络机构注册。另外927例受试者入组其他研究 附属研究中心（ECOG附属机构，参与当地申办者发起的试验的研究中心）。在癌症中心网络站点， 有666名受试者参加了治疗方案，789名参加了涉及其他干预措施的研究，1025名参加了 流行病学或其他观察性研究，以及2324项伴随、辅助或相关研究。重要的是，4332 4804例（90%）受试者和666例治疗性试验受试者中的382例（57%）入组了机构研究 内部或外部资助的试验。在本赠款周期内，开展了五项举措： 开发和加强我们基于互联网的无纸化方案管理系统和临床试验 西北肿瘤学试验信息系统（Northwestern Oncology Trial Information System-NOTIS）。最近，这一举措包括 升级系统，以便将数据库推广到我们的癌症中心附属机构; 2）开发培训 临床工作人员的计划和培训手册; 3）开发和实施NCI批准的数据和安全性 （4）对办事处的财务结构进行重大审查和重组， 财务报告;以及5）对CRO的方案启动过程进行全面审查，并提出建议 将最初的方案批准时间从2004年7月至12月的32周减少到19周 目前。CRO的未来发展将包括扩展NOTIS以包括电子数据 采集（从主要机构电子制图资源）用于当地制药商发起的试验，以及进一步 加强CRO财务跟踪机制，使办事处能够更有效地 准确管理试验的所有财务方面（计费、CRO充值、财务规划等）。