CC: Clinical Research

CC：临床研究

基本信息

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
项目类别：
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

项目摘要

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 SPORE 新创建的资源。现在它结合了患者在上一个资助期间，SPORE 一直在进行并支持的注册管理活动拟议资助期内的新活动涉及支持所有四个转化领域的临床研究研究项目。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。迄今为止，胰腺癌 SPORE 的患者登记活动非常富有成效，累计人数达 2279 人同意的受试者（~325/年），使用超快速病例发现，这是解决这种迅速致命的必要方法癌症。 Mayo Clinic 每年诊断和/或治疗大约 570 名胰腺癌患者三个校区。登记处共有 1612 名胰腺癌患者，其中 >50% 患有胰腺癌加入组织核心中的组织生物样本。此外，登记处还包括有关年龄的数据（第1513章）性别、种族和地区匹配的健康对照。它将与生物统计学核心和组织核心，确保最高质量的带注释生物样本和胰腺用于研究的癌症数据库。登记处的患者招募基础设施将用于招募项目2的受试者。 SPORE将在接下来的时间里对项目1、3和4进行早期临床试验资助期限。它将利用癌症中心支持的临床研究办公室 (CRO) 共享资源实施试验。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，确保SPORE的临床试验顺利进行； 3) 开展所有患者招募活动项目2的三重示踪剂测试； 4）招募新发糖尿病患者支持项目2的验证研究； 5）维持所有三个梅奥诊所的胰腺癌患者超快速病例招募和登记校园； 6）作为未来发展研究和职业发展研究的资源项目。 SPORE 最高层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类受试者法规。