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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.

项目摘要/摘要-核心C：