Biostatistics

生物统计学

• 批准号: 8456111
• 负责人: Elizabeth Garrett-Mayer
• 金额: $ 12.23万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 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/8456111
• 关键词: American College of Radiology Imaging Network; Area; Awareness; Biometry; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Communication; Development; Enrollment; Ensure; Ethics; Future; Gynecologic Oncology Group; Industry; Lead; Malignant Neoplasms; Medical; Medical Research; Medicine; Minority; National Surgical Adjuvant Breast and Bowel Project; Patients; Phase; Physicians; Preparation; Principal Investigator; Radiation Therapy Oncology Group; Records; Research; Research Infrastructure; Research Personnel; Services; South Carolina; Southwest Oncology Group; Staging; Therapeutic Clinical Trial; Time; Training and Education; Universities; base; college; data management; research study; screening

The Rollings Cancer Center (HCC) Clinical Trials Office (CTO) provides a centralized office for the conduct of cancer clinical trials at the Medical University of South Carolina (MUSC). The purpose of the HCC CTO is to provide an effective and efficient clinical research infrastructure to support investigators and clinicians in developing and implementing clinical research studies. The major functions of the CTO are to: Assist HCC Principal Investigators in the activation and administration of studies, including the preparations and communications required for scientific, ethical, financial and operational reviews as well as ongoing support for annual regulatory reviews Assist clinicians in screening and enrolling patients for clinical research studies Coordinate and ensure the completion of patient-specific study requirements Provide data management support for clinical research studies Prepare medical and research records for internal and external quality and compliance audits Provide training and education pertaining to the best practices in conducting clinical studies to clinical and CTO staff as well as new investigators Communicate the availability of clinical studies to HCC physicians, referring physicians and the public Administer the HCC Clinical Trials Network, which promotes statewide clinical trial access Over the past decade the CTO has expanded its capacity, services and capabilities and is considered one of MUSC's most effective and efficient clinical research units. Currently, the HCC CTO provides services to twenty-one MUSC departments/divisions and the clinical trials portfolio includes studies from all of the major NCI Cooperative Group trials (e.g., SWOG, RTOG, GOG, COG, ACRIN, ACoSOG, NSABP), industry sponsored studies and a growing number of investigator-initiated studies. Accrual to therapeutic clinical trials has quadrupled during the past five years and now represents 11% of total new HCC cancer cases.

罗林斯癌症中心 (HCC) 临床试验办公室 (CTO) 为南卡罗来纳医科大学 (MUSC) 的癌症临床试验的开展提供了一个集中办公室。 HCC CTO 的目的是提供有效且高效的临床研究基础设施，以支持研究人员和临床医生开发和实施临床研究。 CTO 的主要职责是： 协助 HCC 首席研究员启动和管理研究，包括科学、伦理、财务和运营审查所需的准备和沟通，以及对年度监管审查的持续支持 协助临床医生筛选和招募患者进行临床研究 协调并确保完成患者特定的研究要求 为临床研究提供数据管理支持 为内部和外部质量及合规性审核准备医疗和研究记录 向临床和 CTO 人员以及新研究者提供有关进行临床研究的最佳实践的培训和教育 传达临床研究的可用性向 HCC 医生、转诊医生和公众管理 HCC 临床试验网络，该网络促进全州范围内的临床试验访问 在过去十年中，CTO 扩大了其能力、服务和能力，并被认为是 MUSC 最有效、最高效的临床研究单位。目前，HCC CTO 为 21 个 MUSC 科室/部门提供服务，临床试验组合包括来自所有主要 NCI 合作组试验（例如 SWOG、RTOG、GOG、COG、ACRIN、ACoSOG、NSA​​BP）、行业的研究赞助的研究和越来越多的研究者发起的研究。过去五年中，治疗性临床试验的数量翻了两番，目前占新发 HCC 癌症病例总数的 11%。