Core D - CLINICAL TRIALS CORE FACILITY

M.D. 安德森癌症中心 SPORE 多发性骨髓瘤临床试验核心设施将 将非常有希望的发现转化为预防、早期检测、诊断、 从实验室到临床的多发性骨髓瘤的预后和/或多发性治疗。协调临床试验 该核心还将促进信息从诊所流回实验室，目标是 帮助告知和优化未来临床干预的设计。为了实现这些 目标，核心将有以下具体目标： 1. 协调开发、提交、 与行政核心设施合作，获得 SPORE 临床试验的监管批准 （核心A）和生物统计学和生物信息学核心设施（核心E）； 2. 协助 SPORE 调查员 快速有效地吸引患者参加 SPORE 项目中出现的转化临床试验； 3. 至 向机构审查委员会和适当机构报告不良事件，并确保合规 与核心 A 合作，遵守所有适用的监管准则； 4. 提供质量控制 SPORE临床试验数据； 5. 与Core E合作分析SPORE研究的临床试验数据； 6. 促进和协调参加 SPORE 试验的患者的相关标本采集 以及骨髓瘤组织核心设施（核心 B）。因此，总而言之，该核心将提供 工作台和床边之间的关键联系将使多发性骨髓瘤中的孢子能够满足其 转化目标，并改善多发性骨髓瘤患者的治疗结果。

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.