CC: Clinical Research

CC：临床研究

• 批准号: 7510973
• 负责人: GLORIA M. PETERSEN
• 金额: $ 15.77万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7510973
• 关键词: Adherence; Adverse event; Advocate; Age; Agreement; Amendment; Biohazardous Substance; Biometry; Biostatistics Core; Budgets; Cancer Center; Cancer Information Service; Cancer Patient; 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; Disease; Documentation; Educational Materials; Elements; Enrollment; Ensure; Evaluation; Event; Funding; Future; Goals; Guidelines; Individual; Industry; 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; Numbers; Nurses; Observational Study; Online Systems; Pancreas; Patient Recruitments; Patients; Persons; Pharmacy facility; Phase; Physicians; Population; Principal Investigator; Process; Program Development; Progress Reports; Protocol Compliance; Protocols documentation; Quality Control; Race; Radiation; Records; Recruitment Activity; Registries; Regulation; Reporting; Reproduction spores; Research; Research Activity; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Project Grants; Research Support; Resource Sharing; Resources; Review Committee; Role; Route; Safety; Sampling; Secure; Services; Specialist; Standardization; Standards of Weights and Measures; System; Telephone; Testing; Time; Tissues; Tracer; Training; Translational Research; United States Food and Drug Administration; Update; Work; abstracting; career; case finding; design; diabetic; experience; follow-up; human subject; innovation; member; patient registry; programs; protocol development; sex; validation studies

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.

临床研究核心是为孢子新创建的资源。它现在结合了患者 登记活动一直在进行，并在上一个供资期间得到孢子的支持 拟议供资期间的新活动涉及支持所有四个翻译项目的临床研究。 研究项目。该中心的主任在人体学科研究和研究方面拥有丰富的经验 招募患者参加研究方案，包括观察性研究和临床试验。到目前为止， 胰腺癌孢子的患者注册活动非常富有成效，累计收益为2279 同意受试者(约325人/年)，使用超快速病例发现，这是治疗这种迅速致命的疾病的必要方法 癌症。梅奥诊所每年诊断和/或治疗约570名胰腺癌患者。 三个校区。登记中有1612名胰腺癌患者，其中50%为胰腺癌 在组织核心中加入的组织生物标本。此外，登记处还包括关于1513年的数据， 性别、种族和地区匹配的健康对照组。它将非常密切地协调其活动与 生物统计核心和组织核心，以确保最高质量的注释生物标本和胰腺 用于研究的癌症数据库。登记处的病人招聘基础设施将用于招聘 项目2的受试者。孢子将在下一个项目1、3和4中进行早期临床试验 资助期。它将利用癌症中心支持的临床研究办公室(CRO)共享资源来 将试验付诸实施。临床研究核心将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，以 确保孢子临床试验的顺利进行；3)执行所有患者招募活动 项目2的三重示踪试验；4)招募新发病的糖尿病患者以支持项目2中的验证研究；5) 在所有三家梅奥医院维持胰腺癌患者的超快病例招募和登记 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。孢子最高级领导人的密切协调和监督将确保所有 临床研究活动以最高水平的研究完整性和遵守所有 人体受试者条例。