CLINICAL TRIALS SUPPORT UNIT

临床试验支持单位

• 批准号: 8181015
• 负责人: Martha P. Mims
• 金额: $ 17.81万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-17 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181015
• 关键词: AIDS Malignancy Consortium; Acquired Immunodeficiency Syndrome; Adult; Adverse event; Ambulatory Care; Amendment; American Society of Clinical Oncology; Area; Biostatistics Shared Resource; Breast; Budgets; Cancer Center; Cancer Trials Support Unit; Cells; Child; Childhood; Clinic; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Database; Clinical Trials Unit; Clinical trial protocol document; Communication; Controlled Clinical Trials; County Hospitals; Credentialing; Data; Data Base Management; Data Collection; Data Reporting; Databases; Date of birth; Development; Discipline of Nursing; Disease; Doctor of Medicine; Doctor of Philosophy; Drug Industry; Economically Deprived Population; Electronic Mail; Enrollment; Ensure; Ethnic Origin; Faculty; Feedback; Floor; Funding; Future; Gender; Gene Transfer; General Hospitals; HIV; Hospitals; Human Resources; Improve Access; Individual; Industry; Informatics; Institution; Interview; Investigator-Initiated Research; Knowledge; Leadership; Learning; Link; Lymphoma; Maintenance; Malignant Neoplasms; Medical center; Medicine; Methodist Church; Minority; Monitor; NCI Center for Cancer Research; Names; New Agents; Newsletter; Nurses; Nursing Research; Online Systems; Outpatients; Patients; Pediatric Hospitals; Pediatrics; Performance; Pharmacologic Substance; Pharmacy facility; Phase; Physicians; Population; Positioning Attribute; Principal Investigator; Procedures; Process; Protocols documentation; Quality Control; Race; Recording of previous events; Regulatory Affairs; Reporting; Research; Research Activity; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Support; Resource Allocation; Resources; Rest; Review Committee; Role; Scientist; Site; Solutions; Southwest Oncology Group; Structure; Summary Reports; System; Texas; Therapeutic Clinical Trial; Time; Training; Training Programs; Training and Education; Uncertainty; Underrepresented Minority; Update; Work; Workload; arm; base; cancer cell; cancer research center director; clinical research site; college; cost effective; experience; gene therapy; improved; innovation; institutional biosafety committee; malignant breast neoplasm; meetings; member; patient registry; programs; quality assurance; repository; response; tumor; web site

The Clinical Trials Support Unit (CTSU) is a central resource for coordination and reporting on all cancer related clinical research within the College and its affiliated hospitals and ambulatory care centers. The CTSU facilitates liaison with investigators, cooperative groups, federal agencies, and the pharmaceutical industry. In the past 3 years, the CTSU has particularly focused on establishing clinical trials infrastructure for investigators and institutions with less prior experience and knowledge in this area in order to increase clinical trial enrollment to a wide spectrum of cancer-related studies. The CTSU has targeted hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. The CTSU provides overall coordination of and reporting on cancer relevant clinical studies in the DLDCC via 4 major functions: 1) Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), maintenance of regulatory files, 2) Clinical trials informatics expertise especially maintaining an electronic database of cancer related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3) Quality assurance auditing and personnel training and 4) Research nursing/clinical trials management especially for less experienced investigators or those with limited programs. The CTSU provides efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and improves access to these trials, especially for underserved minorities. The main offices of the CTSU are in the Cancer Center administrative offices on the 4th floor of the Cullen Bldg at Baylor College of Medicine with CCGT and Pediatric CTSU offices in the Feigin Center. On site offices for Research Nurses/Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Clinic, Texas Children's Hospital, the Methodist Hospital (adult component of the CCGT program), the Ben Taub Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D., Ph.D.

临床试验支持单位（CTSU）是协调和报告学院及其附属医院和门诊护理中心内所有癌症相关临床研究的中心资源。CTSU促进与研究者、合作团体、联邦机构和制药行业的联络。在过去的3年里，CTSU特别关注为研究者和机构建立临床试验基础设施，这些研究者和机构在这一领域的经验和知识较少，以增加广泛的癌症相关研究的临床试验入组。CTSU针对医院和 少数民族和经济困难患者比例较高的机构，为这些人群提供更多参与临床研究的机会。 CTSU通过4个主要职能对DLDCC中的癌症相关临床研究进行总体协调和报告：1）协助与临床研究和试验相关的监管和行政事务，包括IRB合规和批准，正在进行的修订和更新，外部机构合规（如FDA），监管文件的维护，2）临床试验信息学专业知识，特别是维护癌症相关临床方案的电子数据库，患者登记和临床数据，监测和报告应计费用，3）质量保证稽查和人员培训，以及4） 研究护理/临床试验管理，特别是对于经验不足的研究者或项目有限的研究者。 CTSU提供有效的，具有成本效益的支持，以帮助癌症中心的研究人员在科学上有价值的癌症临床试验的进行，并改善这些试验的访问，特别是为服务不足的少数民族。CTSU的主要办公室位于贝勒医学院卡伦大楼4楼的癌症中心行政办公室，CCGT和儿科CTSU办公室位于费金中心。 研究护士/协调员的现场办公室位于学院的每个主要附属临床设施，包括贝勒诊所，得克萨斯州儿童医院，卫理公会医院（成人部分）， CCGT计划）、本·陶布医院和迈克尔·E·。DeBakey VA医疗中心。 资源负责人是Martha Mims，医学博士，博士