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Core--Clinical

核心--临床

基本信息

批准号：
7460930
负责人：
JOSEPH Wayne FAY
金额：
$ 13.46万
依托单位：
BAYLOR RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7460930
关键词：
Academic Medical Centers Accreditation Adherence Adverse event Amendment Area Autologous Blood Blood Component Removal Bone Marrow Transplantation Books CD34 gene Case Report Form Cell Therapy Cells Clinical Clinical Data Clinical Protocols Clinical Research Clinical Research Protocols Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Code Collaborations Collection Color Confidentiality Consent Forms Data Data Collection Dendritic Cell Vaccine Dendritic Cells Documentation Effectiveness Enrollment Ensure Foundations Guanosine Monophosphate Guidelines Health Insurance Portability and Accountability Act Hematopoietic stem cells Human Human Subject Research Immunology Immunotherapy Individual Informed Consent Institutes Laboratories Laboratory Research Laboratory Study Metastatic Melanoma Mission Monitor Monitoring Clinical Trials Mononuclear National Cancer Institute Nursing Staff Operative Surgical Procedures Outcomes Research Patient Participation Patients Performance Personal Computers Pharmaceutical Preparations Policies Principal Investigator Procedures Protocols documentation Records Reporting Research Research Ethics Committees Research Institute Research Personnel Safety Secure Standards of Weights and Measures Time United States Update Vaccine Design Vaccines Writing healthy volunteer human subject improved melanoma monocyte novel strategies patient safety progenitor programs research study response volunteer

项目摘要

The clinical core has the responsibility of implementation and close monitoring of the clinical trials investigating the effectiveness of dendritic cell (DC) immunotherapy for metastatic melanoma as outlined in the specific aims of investigators at the Baylor Institute for Immunology Research. The functions of the Clinical Core are divided into four general areas: (1) Performance of clinical trials involving patients with metastatic melanoma with the highest level of good clinical practice; (2) Implementation of clinical research after approval by the Institutional Review Board (IRB) of the Baylor University Medical Center (BUMC), the National Cancer Institute (NCI) and the United States Federal Drug Administration (FDA); (3) Write, implement and update as necessary a clinical trial monitoring policy as mandated by the Baylor Research Institute (BRI) in Dallas and the FDA in collaboration with our outside clinical protocol monitors to promote accurate collection of clinical and laboratory research data, prompt and comprehensive reporting of adverse events as a result of patient participation in clinical research to the IRB,NCI and FDA and to ensure patient safety; (4) Operate and oversee the apheresis center at BUMC to ensure patient safety and proper collection of autologous mononuclear cells for DC vaccine design; (5) Maintain high quality records of patient participation and document regulatory activities of the clinical research in collaboration with the DC Core in a manner acceptable to the IRB,NCI and FDA. The core will be responsible for the integrity of the clinical outcomes of the research. We have established a Data Safety and Monitoring Board (DSMB) and a Melanoma Trials Overview Committee (MTOC) as oversight entities.

临床中心负责实施和密切监测临床试验调查树突状细胞（DC）免疫疗法对转移性黑色素瘤的有效性，如贝勒免疫学研究所的研究人员。临床核心的功能分为四个一般领域：（1）涉及转移性黑色素瘤患者的临床试验的性能，良好的临床实践;（2）在机构审查委员会（IRB）批准后实施临床研究，贝勒大学医学中心（BUMC）、国家癌症研究所（NCI）和美国联邦药物管制局（FDA）（3）根据美国食品药品监督管理局（FDA）的要求，编写、实施并在必要时更新临床试验监查政策。位于达拉斯的贝勒研究所（BRI）和FDA与我们的外部临床方案监查员合作，促进准确收集临床和实验室研究数据，及时全面报告不良反应，向IRB、NCI和FDA报告患者参与临床研究导致的事件，以确保患者安全;（4）操作和监督BUMC的单采中心，以确保患者的安全和适当的自体血液收集。单核细胞用于DC疫苗设计;（5）保持患者参与的高质量记录，并记录以IRB、NCI可接受的方式与DC核心合作开展临床研究的监管活动和FDA。核心将负责研究临床结局的完整性。我们建立了数据安全和监测委员会（DSMB）和黑色素瘤试验概述委员会（MTOC）作为监督实体。