Core D - CLINICAL TRIALS CORE FACILITY

M.D.安德森癌症中心孢子治疗多发性骨髓瘤的临床试验核心设施将 将极具前景的发现转化为潜在的应用于预防、早期发现、诊断、 多发性骨髓瘤从实验室到临床的预后和/或治疗。协调临床试验 这一核心还将促进信息流从诊所返回实验室，目标是 帮助告知和优化未来临床干预措施的设计。为了实现这些目标 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，对孢子临床试验进行监管批准 (核心A)和生物统计和生物信息学核心设施(核心E)；2.协助孢子调查人员 快速有效地将患者吸引到孢子项目产生的转化性临床试验中； 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，遵循所有适用的监管指南；4.为 孢子临床试验数据；5.与Core E合作分析孢子研究的临床试验数据； 6.促进和协调从参与孢子试验的患者中收集相关标本 以及骨髓瘤组织核心设施(核心B)。因此，总而言之，此核心将提供 长凳和床边之间的关键环节，将使多发性骨髓瘤中的这个孢子满足它的 翻译目标，并改善多发性骨髓瘤患者的预后。

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.