Core B: Clinical Trials Core

核心 B：临床试验核心

• 批准号: 10554476
• 负责人: SCOTT Michael SCHUETZE
• 金额: $ 25.04万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-14 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10554476
• 关键词: Adverse event; Basic Science; Biometry; Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Support Unit; Collaborations; Collection; Communication; Complex; Computational Biology; Conduct Clinical Trials; Data; Development; Ensure; Good Clinical Practice; Human; Image; Informed Consent; Infrastructure; Institution; Institutional Review Boards; Leadership; Locally Advanced Malignant Neoplasm; Maintenance; Medical Oncology; Mentors; Michigan; Molecular Target; Monitor; Outcome; Participant; Pathology; Patient Recruitments; Patients; Population Research; Principal Investigator; Process; Protocols documentation; Publications; Questionnaires; Radiation Oncology; Radiosensitization; Reporting; Research; Research Personnel; Research Project Grants; Resources; Review Committee; Safety; Services; Thinness; Translational Research; Translations; Universities; adverse event monitoring; cancer clinical trial; cancer type; career; clinical trial implementation; data management; data sharing; experience; medical schools; mortality; patient retention; programs; protocol development; quality assurance; recruit; skills; tool

PROJECT SUMMARY/ABSTRACT (CLINICAL TRIALS CORE) The University of Michigan Rogel Cancer Center Molecularly Targeted Radiosensitization of Locally Advanced Cancers SPORE aims to reduce mortality for multiple types of cancer through bringing basic science research to the patient in a rapid, efficient and scientifically rigorous approach. For research discoveries to move smoothly and efficiently into clinical trials, there needs to be a coordinated infrastructure with a focus on the translational outcome. The Clinical Trials (CT) Core will augment services provided by the University of Michigan (UM) Rogel Cancer Center’s Oncology-Clinical Trials Support Unit (O-CTSU) and the University of Michigan IND/IDE Investigator Assistance Program to provide a seamless infrastructure to facilitate the rapid and efficient development, initiation and completion of clinical trials assuring all trials meet Good Clinical Practice (GCP) and adhere to rigorous scientific principles. The CT Core will be a lean core and not duplicate effort provided by the Cancer Center and UM. The CT Core will be staffed by a Radiation Oncology Director and Medical Oncology Director, Clinical Research Project Manager and Clinical Research Coordinator. The CT Core staff will support all aspects of clinical trials implementation and conduct including protocol development and approval by regulatory entities, protocol activation, participant identification, recruitment, informed consent process, monitoring for adverse events, data and biosample collection and handling, and reporting of study results. The CT Core will collaborate with the O-CTSU to manage regulatory aspects and data entry for SPORE clinical trials. SPORE clinical trials will undergo auditing and monitoring by the Cancer Center’s Quality Assurance and Review Committee (QARC) and findings will be reviewed by the CT Core Director and the Cancer Center’s Data and Safety Monitoring Committee (DCMC). The CT Core Directors will meet monthly with the SPORE clinical trial Principal Investigators to ensure communication, optimize usage of Core resources, and review progress on development, implementation and conduct of SPORE clinical trials. The Directors and staff will mentor and educate all investigators on GCP for clinical research, especially the applicants and awardees of the Career Enhancement Program (CEP). The Directors will review progress on analysis of trial results with trial Principal Investigators, the Biostatistics and Computational Biology (BCB) Core and Translational Pathology (TP) Core to ensure timely publication of SPORE trials results.

项目摘要/摘要（临床试验核心） 密歇根大学罗杰癌癌症中心分子靶向局部的放射敏化 高级癌症孢子的目的是通过带来基本 科学研究以快速，高效且科学严格的方法向患者提供。进行研究 发现平稳而有效地进入临床试验的发现，需要协调一致 基础设施着重于转化结果。临床试验（CT）核心将增加服务 由密歇根大学（UM）Rogel癌症中心的肿瘤学临床试验支持部门提供 （O-CTSU）和密歇根大学IND/IDE研究员协助计划 无缝基础设施，以促进快速有效的发展，主动性和完成 确保所有试验符合良好临床实践（GCP）并遵守严格的科学原则的临床试验。 CT核心将是癌症中心和UM提供的精益核心，而不是重复的努力。 CT核心 临床研究项目的辐射肿瘤学总监和医学肿瘤学总监将组成 经理和临床研究协调员。 CT核心人员将支持临床试验的各个方面 实施和行为，包括协议制定和监管实体的批准，协议 激活，参与者识别，招聘，知情同意过程，监视不良事件， 数据和生物样本的收集和处理以及研究结果的报告。 CT核心将合作 使用O-CTSU来管理孢子临床试验的监管方面和数据输入。孢子临床试验 癌症中心的质量保证和审查委员会将接受审计和监测 （QARC）和调查结果将由CT核心主任和癌症中心的数据和安全审查 监测委员会（DCMC）。 CT核心主管将每月与孢子临床试验本金开会 调查人员确保沟通，优化核心资源的使用并审查进度 孢子临床试验的开发，实施和行为。董事和工作人员将指导和 对所有研究人员进行GCP的临床研究，特别是 职业增强计划（CEP）。董事将通过试验审查试验结果的分析进度 主要研究人员，生物统计学和计算生物学（BCB）核心和转化病理学 （TP）核心确保及时发布孢子试验结果。