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.

项目总结/摘要（临床试验核心） 密歇根大学Rogel癌症中心分子靶向放射增敏局部 先进的癌症孢子旨在降低死亡率为多种类型的癌症，通过把基本的 以快速、高效和科学严谨的方法为患者提供科学研究。研究 为了使新发现顺利有效地进入临床试验，需要有一个协调的 基础设施，重点是翻译结果。临床试验（CT）核心将增加服务 由密歇根大学（UM）Rogel癌症中心的肿瘤临床试验支持部门提供 （O-CTSU）和密歇根大学IND/IDE研究者援助计划， 无缝的基础设施，以促进快速和有效的开发，启动和完成 临床试验，确保所有试验符合良好的临床实践（GCP），并坚持严格的科学原则。 CT核心将是一个精简的核心，而不是重复的努力，由癌症中心和UM提供。CT核心 将配备放射肿瘤学主任和医学肿瘤学主任，临床研究项目 经理和临床研究协调员。CT核心工作人员将支持临床试验的各个方面 实施和执行，包括方案制定和监管机构的批准，方案 激活、受试者识别、招募、知情同意过程、不良事件监测， 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 与O-CTSU一起管理SPORE临床试验的监管方面和数据录入。SPORE临床试验 将接受癌症中心质量保证和审查委员会的审计和监督 （QARC）和结果将由CT核心主任和癌症中心的数据和安全性审查 监测委员会。CT核心总监将每月与SPORE临床试验负责人会面 调查人员应确保沟通，优化核心资源的使用，并审查 开发、实施和开展SPORE临床试验。主任和工作人员将指导和 对所有研究者进行临床研究GCP教育，特别是申请人和获奖者 职业提升计划（CEP）。董事将检讨试验结果分析的进展， 主要研究者，生物统计学和计算生物学（BCB）核心和转化病理学 (TP)核心，以确保及时发表SPORE试验结果。