Clinical Research Core

临床研究核心

• 批准号: 8738917
• 负责人: GLORIA M. PETERSEN
• 金额: $ 24.38万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738917
• 关键词: Adherence; Age; Biostatistics Core; Cancer Center; Cancer Patient; Clinic; Clinical Research; Clinical Trials; Communities; Consent; Data; Data Collection; Databases; Development; Diagnosis; Ensure; Funding; Future; Goals; Human; K-Series Research Career Programs; Malignant Neoplasms; Malignant neoplasm of pancreas; Methods; Observational Study; Pancreatic Adenocarcinoma; Patient Recruitments; Phase; Policies; Program Research Project Grants; Protocols documentation; Race; Recruitment Activity; Registries; Regulation; Research; Research Activity; Research Infrastructure; Research Personnel; Research Project Grants; Resources; System; Tissues; Translational Research; case finding; experience; follow-up; high standard; human subject; patient population; patient registry; sex

The Clinical Research Core combines the ongoing Patient Registry activities with the new clinical trial activities in all four translational research projects in the proposed funding period. The aims of the Clinical Research Core are to: 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 early-phase clinical trials; 3) perform all patient recruitment activities for the clinical trials in the SPORE projects; 4) maintain the ultra-rapid case recruitment and registry of pancreatic cancer patients; and 6) serve as a resource to future Developmental Research Program and Career Developmental Program 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. Mayo Clinic diagnoses and/or treats an estimated 650 pancreatic cancer patients per year across its three campuses. To date, the pancreatic cancer SPORE¿s Patient Registry activities have been very productive, with accrual of 5,395 consented subjects, using ultra-rapid case finding, a necessary method for this rapidly fatal cancer. There are 3,121 pancreatic adenocarcinoma cancer patients in the Registry. In addition, the Registry includes data on over 2,500 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 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.

临床研究核心将正在进行的患者登记活动与新的临床试验相结合 所有四个翻译研究项目在拟议资助期内的活动。临床研究的目的 研究的核心是：1)执行必要的临床试验管理支持活动；2)集中 与癌症中心CRO的基础设施协调所有活动，以确保顺利执行 孢子S早期临床试验；3)执行临床试验的所有患者招募活动 孢子计划；4)维持胰腺癌患者的超快病例招募和登记；以及 6)作为未来发展研究计划和职业发展计划的资源 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。梅奥诊所 该校三个校区每年诊断和/或治疗约650名胰腺癌患者。至 今天，胰腺癌孢子S患者登记活动一直很有成效，收入 5395名同意的受试者使用超快速病例查找，这是治疗这种迅速致命的癌症的必要方法。 该登记处共有3,121名胰腺癌患者。此外，注册处 包括2500多名年龄、性别、种族和地区匹配的健康对照的数据。它将协调其 与生物统计核心和组织核心非常密切的活动，以确保最高质量的注释 生物制品和胰腺癌研究数据库。委员会的密切协调和监督 孢子中心的大多数高级领导将确保所有临床研究活动都是在 最高水平的研究诚信，并遵守所有人类受试者的规定。