Core C - Clinical Trials

核心 C - 临床试验

• 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
• 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

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.

项目摘要/摘要-核心C： Core C将提供经验丰富、训练有素的临床试验人员，专门实施翻译、 药理抗坏血酸(P-Asch-)的临床研究。这组临床研究人员一直在 在过去10年中进行临床试验，并已启动并完成了1期和2期试验 P-Asch-在胰腺、肺和GBM受试者中联合放射和/或化疗。核心C将 使用P-Asch启动、实施和完成复杂人类受试者的所有方面的研究-这是 在项目1和2中提出。核心C还将与核心B对接，以获取患者样本和 为生物标记物评估进行处理，并为参与的员工建立结构化的培训计划 在每一项临床试验研究工作中。该培训计划将包括如何审查以下流程的指导 资格确定以及抗坏血酸治疗输液的审查(包括管理、审查 和禁忌症)和不良事件报告。此外，核心C将提供专家指导和 资源以及与霍尔顿综合癌症中心临床试验基础设施的接口[即， 议定书审查和监测委员会(PRMC)/数据和安全监测委员会(DSMC)]以确定 和报告所有关键研究数据，并设计电子病例报告表格，以完成数据捕获，并 确保向FDA报告最终结果的数据准确性，以及在编制同行- 回顾了出版物。