CC: Clinical Research

CC：临床研究

• 批准号: 8719569
• 负责人: GLORIA M. PETERSEN
• 金额: $ 18.41万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-12 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8719569
• 关键词: Adherence; Adverse event; Advocate; Age; Agreement; Amendment; Biohazardous Substance; Biometry; Biostatistics Core; Budgets; Cancer Center; Cancer Information Service; Cancer Patient; Cancer Therapy Evaluation Program; Case Report Form; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical trial protocol document; Collaborations; Comorbidity; Confidentiality; Consent; Consent Forms; Data; Data Collection; Databases; Development; Diagnosis; Discipline of Nursing; Disease; Documentation; Educational Materials; Elements; Enrollment; Ensure; Evaluation; Event; Funding; Future; Goals; Guidelines; Individual; Industry; Institutional Review Boards; Intranet; K-Series Research Career Programs; Label; Legal; Maintenance; Malignant Neoplasms; Malignant neoplasm of pancreas; Medical; Medical History; Medical Records; Methods; Modification; Monitor; North Central Cancer Treatment Group; Notification; Observational Study; Online Systems; Pancreas; Patient Recruitments; Patients; Persons; Pharmacy facility; Phase; Physicians; Principal Investigator; Process; Progress Reports; Protocol Compliance; Protocols documentation; Quality Control; Race; Radiation; Records; Recruitment Activity; Registries; Regulation; Reporting; Research; Research Activity; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Resource Sharing; Resources; Review Committee; Role; Safety; Sampling; Secure; Services; Specialist; Standardization; System; Telephone; Testing; Time; Tissues; Tracer; Training; Translational Research; United States Food and Drug Administration; Update; Work; abstracting; career development; case finding; design; diabetic; experience; follow-up; human subject; innovation; meetings; member; patient population; patient registry; programs; protocol development; protocol violation; research and development; sex; validation studies; web site

The Clinical Research Core is a newly created resource for the SPORE. It now combines the Patient Registry activities that have been ongoing and supported by the SPORE in the previous funding period with the new activities in the proposed funding period related to support for clinical studies in all four translational research projects. The directors of this Core have extensive experience in studies of human subjects and recruitment of patients to research protocols, both for observational studies and clinical trials. To date, the pancreatic cancer SPORE'S Patient Registry activities have been very productive, with accrual of 2279 consented subjects (~325/year), using ultra-rapid case finding, a necessary method for this rapidly fatal cancer. Mayo Clinic diagnoses and/or treats an estimated 570 pancreatic cancer patients per year across its three campuses. There are 1612 pancreatic cancer patients in the Registry, of which >50% have pancreatic tissue biospecimens accessioned in the Tissue Core. In addition, the Registry includes data on 1513 age, sex, race, and region-matched healthy controls. It will coordinate its activities very closely with the Biostatistics Core and the Tissue Core to ensure the highest quality annotated biospecimens and pancreatic cancer database for research. The infrastructure for patient recruitment in the Registry will be used to recruit subjects for Project 2. The SPORE will conduct early phase clinical trials in Projects 1, 3, and 4 in the next funding period. It will utilize the Cancer Center-supported Clinical Research Office (CRO) shared resource to operationalize the trials. The Clinical Research Core will 1) perform the necessary clinical trial management support activities; 2) centrally coordinate all activities with the infrastructure of the Cancer Center CRO to ensure smooth execution of the SPORE'S clinical trials; 3) perform all patient recruitment activities for the triple tracer test for Project 2; 4) recruit new onset diabetics to support the validation study in Project 2; 5) maintain the ultra-rapid case recruitment and registry of pancreatic cancer patients at all three Mayo campuses; and 6) serve as a resource to future developmental research and career development research projects. The close coordination and oversight of the most senior leaders of the SPORE will ensure that all clinical research activities are performed with the highest level of research integrity and adherence to all human subjects regulations.

临床研究核心是为SPORE新创建的资源。它现在结合了患者 在上一个资助期内一直在进行并得到SPORE支持的注册中心活动， 拟议资助期内的新活动涉及支持所有四个转化医学领域的临床研究， 研究项目。该中心的主任在人类受试者研究方面具有丰富的经验， 招募患者参与研究方案，包括观察性研究和临床试验。迄今为止 胰腺癌SPORE的患者登记活动非常富有成效，累计2279人 知情同意的受试者（约325例/年），使用超快速病例发现，这是快速致死性 癌马约诊所每年估计诊断和/或治疗570名胰腺癌患者 三个校园在登记处中有1612名胰腺癌患者，其中>50%患有胰腺癌。 组织核心中加入的组织生物标本。此外，登记册还包括15 - 13岁的数据， 性别、种族和地区匹配的健康对照。它将与联合国秘书长密切协调其活动， 生物统计学核心和组织核心，以确保最高质量的注释生物标本和胰腺 癌症数据库进行研究。登记研究中的患者招募基础设施将用于招募 项目2的主题。未来，SPORE将在项目1、3和4中进行早期临床试验。 融资期。它将利用癌症中心支持的临床研究办公室（CRO）共享资源， 进行审判临床研究中心将1）执行必要的临床试验管理 支持活动; 2）与癌症中心CRO的基础设施集中协调所有活动， 确保SPORE临床试验的顺利执行; 3）执行所有患者招募活动， 项目2的三重示踪剂试验; 4）招募新发糖尿病患者以支持项目2中的验证研究; 5） 在所有三个马约保持超快速病例招募和胰腺癌患者登记 校园;以及6）作为未来发展研究和职业发展研究的资源 项目SPORE最高级领导人的密切协调和监督将确保所有 临床研究活动是以最高水平的研究完整性和遵守所有 人体实验规定。