Core D - CLINICAL TRIALS CORE FACILITY

核心 D - 临床试验核心设施

• 批准号: 8326175
• 负责人: DONNA R WEBER
• 金额: $ 13.75万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 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/8326175
• 关键词: Adverse event; Back; Basic Science; Bioinformatics; Biometry; Cancer Center; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Conduct Clinical Trials; Core Facility; Data; Development; Diagnosis; Early Diagnosis; Enrollment; Future; Goals; Guidelines; Institutional Review Boards; Intervention; Laboratories; Link; Multiple Myeloma; Outcome; Patients; Pennsylvania; Prevention; Quality Control; Reporting; Research Personnel; Tissues; Translating; Translational Research; Universities; bench to bedside; design; improved; meetings; outcome forecast; sample collection; translational clinical trial

The Clinical Trials Core Facility of The M. D. Anderson Cancer Center SPORE in Multiple Myeloma will translate highly promising findings with potential application to the prevention, early detection, diagnosis, prognosis, and/or treatment of multiple myeloma from the laboratory to the clinic. Clinical trials coordinated by this Core will also promote the flow of information from the clinic back to the laboratory, with the goal of helping to inform and optimize the design of future clinical interventions. In order to accomplish these objectives, the Core will have the following specific aims: 1. To coordinate the development, submission, and regulatory approval of the SPORE clinical trials, in collaboration with the Administrative Core Facility (Core A) and the Biostatistics and Bioinformatics Core Facility (Core E); 2. To assist SPORE investigators in rapidly and efficiently accruing patients to translational clinical trials emerging from SPORE Projects; 3. To report adverse events to the Institutional Review Board and appropriate agencies, and assure compliance with all applicable regulatory guidelines, in collaboration with Core A; 4. To provide quality control of the SPORE clinical trial data; 5. To analyze clinical trials data from SPORE studies in collaboration with Core E; and 6. To facilitate and coordinate correlative specimen collection from patients enrolled on SPORE trials along with the Myeloma Tissue Core Facility (Core B). Taken together, therefore, this Core will provide the crucial link between the bench and the bedside that will allow this SPORE in Multiple Myeloma to meet its translational goals, and improve the outcomes of patients with multiple myeloma.

临床试验中心的M。D.安德森癌症中心多发性骨髓瘤孢子将 将极具前景的发现转化为潜在的预防、早期检测、诊断， 预后和/或从实验室到临床的多发性骨髓瘤的治疗。协调临床试验 该核心还将促进信息从诊所返回实验室，其目标是 有助于为未来的临床干预提供信息并优化设计。为了完成这些 根据这些目标，核心将有以下具体目标：1.协调开发，提交， 与行政核心基金合作，对SPORE临床试验进行监管批准 (Core A）以及生物统计学和生物信息学核心设施（Core E）; 2.协助SPORE调查人员 快速有效地将患者纳入SPORE项目的转化临床试验; 3.到 向机构审查委员会和相关机构报告不良事件，并确保依从性 与核心A合作，遵守所有适用的监管指南; 4.提供质量控制， SPORE临床试验数据; 5.与Core E合作分析来自SPORE研究的临床试验数据; 和6.促进和协调从入组SPORE试验的患者中采集相关样本 沿着骨髓瘤组织核心机构（核心B）。总之，这一核心将提供 板凳和床边之间的关键环节，这将使这个孢子在多发性骨髓瘤，以满足其 翻译目标，并改善多发性骨髓瘤患者的预后。