Case Comprehensive Cancer Center NCTN Lead Academic Participating Site

案例综合癌症中心 NCTN 领先学术参与站点

基本信息

批准号：
10590612
负责人：
Aaron Thomas Gerds
金额：
$ 136.4万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-03-15 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10590612
关键词：
Address Advisory Committees American College of Radiology Imaging Network Biological Markers Brain Breast Cancer Center Cancer Patient Clinic Clinical Clinical Data Clinical Research Clinical Trials Clinical Trials Network Clinical Trials Unit Collaborations Communication Communities Community Clinical Oncology Program Component of the National Cancer Institute Comprehensive Cancer Center County Data Data Analyses Development Developmental Therapeutics Program Diagnosis Diagnostic Disease Early Therapeutic-Clinical Trials Network Eastern Cooperative Oncology Group Education Educational process of instructing Ensure Faculty Funding Future Generations Genitourinary system Goals Gynecologic Hematology Hospitals Image Individual Industry Infrastructure Institution Investigation Lead Leadership Lung Malignant Neoplasms Medical Mentors Meta-Analysis Minority Mission Multi-Institutional Clinical Trial National Cancer Institute National Clinical Trials Network Ohio Oncology Operative Surgical Procedures Orphan Patient Care Patients Phase Physicians Pilot Projects Population Heterogeneity Positioning Attribute Procedures Protocols documentation Quality Control Quality of life Radiation Research Research Personnel Role Services Site Southwest Oncology Group System Time Tissue Sample Translational Research Underrepresented Populations Universities University Hospitals Vision biobank cancer care cancer therapy cancer type clinical infrastructure data management data submission design experience gastrointestinal hospital organization improved improved outcome industry partner innovation interest medical schools medical specialties meetings melanoma member operation performance site programs prospective protocol development quality assurance rare cancer recruit secondary analysis success trial planning

项目摘要

PROJECT SUMMARY This project represents the comprehensive efforts of the oncology community at Case Western Reserve University School of Medicine and its three major teaching affiliate hospitals (University Hospitals, Cleveland Clinic, and MetroHealth) to participate as a Lead Academic Participating Site in the National Clinical Trials Network (NCTN). The NCTN, funded and directed by the National Cancer Institute (NCI), is the major consortium for performing federally-funded, national multicenter clinical trials that aim to improve outcomes for cancer patients. The emphasis of NCTN trials is late phase (phase III and relatively large Phase II) trials that address scientific questions that usually cannot be answered by other means such as a single-institution study or an industry company study. The results of these trials often set the standards of care for cancer treatment in the U.S. and the world. This includes clinical trials research in rare cancers and underrepresented populations. Our specific aims for this project are 1) to participate in NCTN trials with exceptionally high levels of accrual volume and quality of data generation and submission for approximately 240 new patients per year; 2) to serve the NCTN and the cancer community by providing scientific and administrative leadership in the (Cooperative) Groups that design and operate these NCTN clinical trials in the entire broad portfolio of cancers; in particular we are full members with many investigator leaders within NRG Oncology, ECOG-ACRIN and SWOG; and 3) to perform and present hypothesis-based, investigator-led research that benefits future NCTN research. This includes secondary clinical and biorepository translational analyses from NCTN data and pilot studies from our institution. We achieve these aims by assembling an outstanding core of investigators representing all the major cancer specialties (surgical, radiation, medical and diagnostic oncology) and disease sites (hematologic, lung, breast, gastrointestinal, genitourinary, brain, gynecologic and melanoma). We have also developed a robust infrastructure of clinical trials operations in support of the NCTN, including the centralized facilities at Case Western and the hospital-based clinical trials units. They ensure timely activation of, and education about, NCTN trials, accrual enhancement, regulatory management and a high quality of research procedures and data submission. Finally, a major priority is the recruitment, development and mentoring of new Case Western investigators' involvement within the NCTN, including their participation in the Groups' activities such as their semi-annual meetings and committee assignments.

项目概要该项目代表了凯斯西储肿瘤学界的综合努力大学医学院及其三大教学附属医院（University Hospitals, Cleveland Clinic 和 MetroHealth）作为主要学术参与点参与国家临床试验网络（NCTN）。 NCTN 由美国国家癌症研究所 (NCI) 资助和指导，是主要联盟用于进行联邦资助的国家多中心临床试验，旨在改善癌症的结果患者。 NCTN 试验的重点是后期（III 期和相对较大的 II 期）试验，旨在解决通常无法通过其他方式（例如单一机构研究或联合研究）来回答的科学问题行业公司研究。这些试验的结果通常设定了癌症治疗的护理标准美国和世界。这包括针对罕见癌症和代表性不足人群的临床试验研究。我们的该项目的具体目标是 1) 以极高的应计量参与 NCTN 试验每年约 240 名新患者的数据生成和提交质量； 2）为NCTN服务和癌症界，通过在（合作）小组中提供科学和行政领导，在整个广泛的癌症组合中设计和实施这些 NCTN 临床试验；特别是我们已经满了成员，包括 NRG Oncology、ECOG-ACRIN 和 SWOG 内的许多研究者领导者； 3）执行并提出基于假设、研究者主导的研究，这有利于未来的 NCTN 研究。这包括根据 NCTN 数据和我们机构的试点研究进行二次临床和生物样本库转化分析。我们通过组建代表所有主要癌症的杰出研究人员核心来实现这些目标专业（外科、放射、医学和诊断肿瘤学）和疾病部位（血液、肺、乳腺、胃肠道、泌尿生殖系统、大脑、妇科和黑色素瘤）。我们还开发了一个强大的支持 NCTN 的临床试验运营基础设施，包括凯斯的集中设施以西医和医院为基础的临床试验单位。他们确保 NCTN 的及时激活和教育试验、权责发生制增强、监管管理以及高质量的研究程序和数据提交。最后，一个主要优先事项是新 Case Western 的招聘、发展和指导调查员参与 NCTN 的情况，包括他们参与该组织的活动，例如他们的活动半年度会议和委员会任务。