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.

项目摘要该项目代表了Case Western Reserve肿瘤学社区的全面努力大学医学院及其三个主要教学会分支机构医院（克利夫兰大学医院诊所和MetroHealth）将作为国家临床试验的主要学术参与地点参加网络（NCTN）。由国家癌症研究所（NCI）资助和指导的NCTN是主要财团用于进行联邦资助的国家多中心临床试验，旨在改善癌症的预后患者。 NCTN试验的重点是后期（第三阶段和相对较大的II期）试验，以解决通常无法通过其他手段（例如单一机构研究或）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对癌症治疗的护理标准美国和世界。这包括在罕见癌症和代表性不足的人群中进行的临床试验研究。我们的该项目的具体目的是1）参加NCTN试验，具有极高的应计量每年大约240名新患者的数据生成和提交质量； 2）为NCTN服务以及癌症社区通过在（合作）群体中提供科学和行政领导在整个广泛的癌症组合中设计和操作这些NCTN临床试验；特别是我们很满 NRG肿瘤学，Ecog-acrin和Swog中许多研究者领导者的成员； 3）执行并提出了基于假设的研究人员主导的研究，从而使未来的NCTN研究受益。这包括来自我们机构的NCTN数据和试点研究的次要临床和生物座位转化分析。我们通过组建代表所有主要癌症的研究人员的出色核心来实现这些目标专业（手术，辐射，医学和诊断肿瘤学）和疾病部位（血液学，肺，乳房，胃肠道，泌尿生殖器，大脑，妇科和黑色素瘤）。我们也发展了一个强大的临床试验操作的基础设施以支持NCTN，包括案件的集中设施西方和基于医院的临床试验单元。它们确保及时激活和教育NCTN 试验，应计增强，监管管理以及高质量的研究程序和数据提交。最后，重点是招募，开发和指导新案件西方调查人员参与NCTN，包括他们参与小组活动（例如他们的活动）半年度会议和委员会任务。