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结合起来 拟议资助期内所有四个转化研究项目的活动。临床的目的 研究核心是： 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 SPORE 的早期临床试验； 3) 开展临床试验的所有患者招募活动 孢子项目； 4）维持胰腺癌患者的超快速病例招募和登记；和 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。该核心的主任在人类学科研究方面拥有丰富的经验 招募患者参加研究方案，用于观察性研究和临床试验。梅奥诊所 据估计，三个校区每年诊断和/或治疗 650 名胰腺癌患者。到 迄今为止，胰腺癌 SPORE 的患者登记活动非常富有成效，累计了 5,395 名受试者同意，使用超快速病例发现，这是治疗这种快速致命癌症的必要方法。 登记处共有 3,121 名胰腺癌患者。此外，登记处 包括超过 2,500 名年龄、性别、种族和地区匹配的健康对照者的数据。它将协调其 与生物统计核心和组织核心密切合作的活动，以确保注释的最高质量 用于研究的生物样本和胰腺癌数据库。各部门的密切协调和监督 SPORE 的最高层领导将确保所有临床研究活动均在 最高水平的研究诚信并遵守所有人类受试者法规。