Core C - Clinical Trials

核心 C - 临床试验

基本信息

批准号：
10240535
负责人：
JOHN M. BUATTI
金额：
$ 17.61万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-19 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10240535
关键词：
Adherence Adverse event Annual Reports Ascorbic Acid Biological Markers Case Report Form Chemotherapy and/or radiation Clinical Clinical Cancer Center Clinical Data Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Code Complement Complex Comprehensive Cancer Center Data Development Dose Education Eligibility Determination Ensure Ethics Glioblastoma Human Human Subject Research Infrastructure Infusion procedures Institutional Review Boards Instruction Investigational Drugs Investigational New Drug Application Iowa Lung Malignant neoplasm of lung Malignant neoplasm of pancreas Manuscripts Metabolism Monitor Non-Small-Cell Lung Carcinoma Oxidation-Reduction Pancreas Participant Patients Peer Review Pharmacologic Ascorbate Phase Phase I/II Trial Preparation Principal Investigator Procedures Process Protocols documentation Publications Radiation Radiation Oncology Radiation therapy Reporting Research Research Personnel Resources Safety Sampling Site Structure Training Training Programs Universities adverse outcome ascorbate base biomarker evaluation cancer therapy chemotherapy design experience gemcitabine improved in vivo insight iron metabolism novel therapeutic intervention patient derived xenograft model phase I trial phase II trial preclinical study predicting response programs recruit screening standard of care therapy outcome trial design

项目摘要

Project Summary/Abstract - Core C: Core C will provide experienced, well-trained clinical trials staff specializing in implementing translational, clinical research involving pharmacological ascorbate (P-AscH-). This group of clinical researchers has been doing clinical trials for the past 10 years and has initiated as well as completed phase 1 and 2 trials using P-AscH- combined with radiation and/or chemotherapy in pancreas, lung, and GBM subjects. Core C will initiate, conduct, and complete all aspects of complex human subjects research with P-AscH- which are proposed in Projects 1 and 2. Core C will also interface with Core B for patient sample acquisition and processing, for biomarker evaluation as well as establishing a structured training program for staff participating in each clinical trial research effort. This training program will include instruction in how to review processes for eligibility determination as well as the review of ascorbate therapy infusions (including administration, review of and contraindications) and adverse event reporting. In addition, Core C will provide expert guidance and resources as well as interface with the Holden Comprehensive Cancer Center clinical trials infrastructure [(i.e., Protocol Review & Monitoring Committee (PRMC)/ Data and Safety Monitoring Committee (DSMC)] to identify and report all key research data, and to design electronic case report forms for complete data capture, and to ensure data veracity for ultimate result reporting to the FDA, and as well as in the preparation of peer- reviewed publications.

项目总结/摘要 - 核心 C：核心 C 将提供经验丰富、训练有素的临床试验人员，专门从事转化、涉及药理学抗坏血酸（P-AscH-）的临床研究。这组临床研究人员已过去 10 年进行临床试验，并已启动并完成了 1 期和 2 期试验 P-AscH-与胰腺、肺和 GBM 受试者的放疗和/或化疗相结合。核心C将使用 P-AscH- 启动、进行和完成复杂人类受试者研究的各个方面，这些研究是项目 1 和 2 中提出。核心 C 还将与核心 B 连接，用于患者样本采集和处理、生物标志物评估以及为参与的工作人员建立结构化培训计划在每项临床试验研究工作中。该培训计划将包括如何审查流程的指导资格确定以及抗坏血酸治疗输注的审查（包括给药、审查和禁忌症）和不良事件报告。此外，Core C 将提供专家指导和资源以及与霍顿综合癌症中心临床试验基础设施的接口[（即，方案审查和监测委员会 (PRMC)/数据和安全监测委员会 (DSMC)] 确定并报告所有关键研究数据，并设计电子病例报告表以获取完整的数据，并确保向 FDA 报告最终结果以及准备同行评审的数据准确性审查出版物。