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clinical research office

临床研究办公室

基本信息

批准号：
7666678
负责人：
TIMOTHY M KUZEL
金额：
$ 48.47万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7666678
关键词：
Adherence 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 Evaluation Funding Future Grant Guidelines Healthcare Hematology Hospitals Information Systems Institutes Institution Internet Intervention Laboratories Malignant - descriptor Malignant Neoplasms Manuals Medical Oncology Medical center Monitor Numbers Observational Study Procedures Process Protocols documentation Radiation Oncology Range Recommendation Rehabilitation therapy Reporting Research Research Ethics Committees Research Personnel Research Proposals Resources Safety Site Specimen Structure Supervision Surgical Oncology System Therapeutic Therapy Clinical Trials Time Training Training Programs Universities Week Work anticancer research base follow-up human subject member neuro-oncology oncology protocol development quality assurance response

项目摘要

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...).

Robert H. Lurie综合癌症中心的临床研究办公室（CRO）参与了各个层面的研究