Administrative and Communication Core

行政和沟通核心

• 批准号: 8566973
• 负责人: Nikhil C. Munshi
• 金额: $ 15.67万
• 依托单位: DANA-FARBER CANCER INST
• 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/8566973
• 关键词: Advisory Committees; Automobile Driving; Biological Markers; Bortezomib; Cancer Center; Clinical; Clinical Research; Clinical Trials; Communication; Dana-Farber Cancer Institute; Development; Dexamethasone; Dose; Event; France; Genome; Genomic Instability; Genomics; Goals; Innovative Therapy; Institutes; Instruction; International; Laboratories; Link; Molecular; Molecular Abnormality; Monitor; Multiple Myeloma; Newly Diagnosed; Normal Cell; Outcome; Patients; Process; Research; Research Personnel; Research Project Grants; Resources; Sampling; Science; Site; Therapeutic Agents; Tissue Banks; Travel; cancer genomics; data exchange; lenalidomide; meetings; new therapeutic target; programs; sample collection; translational medicine

This proposal brings together the translational medicine expertise of Dana-Farber Cancer Institute (DFCI) with the clinical research strength of Intergroupe Francophone du Myeloma (IFM) in France and the genomics expertise of the Sanger Institute in the UK to develop a curative strategy for MM. In the proposed international collaborative project, we will initiate the most important clinical trial in MM to date, integrating bortezomib, lenalidomide and dexamethasone with high dose therapy in an effort to pursue cure in MM (Project 1). This trial will provide 1000 MM and normal cell samples from newly diagnosed and uniformly treated patients to comprehensively characterize the MM genome and to define molecular events driving development and progression of MM (Project 2); to identity novel therapeutic targets and agents (Project 3) and biomarkers (Projects 1,2,4); as well as to define the mechanism and clinical implications of genomic instability in MM (Project 4). The ultimate goal of the research projects in this program is to identify oncogenomic changes and their relationship with clinical outcome; and to identify and develop innovative therapies targeting molecular abnormalities in MM. This unique collaborative effort requires significant coordination of effort, integration of strategies, monitoring and oversight of various functions, and communication between investigators at various dispersed sites. The key function of Core A is integration of the research efforts and communication between investigators. Scientific and administrative integration is essential to assure successful interaction between the four Projects, as well as between the laboratory and clinical components within and between projects in this multinational multi-institutional program. Therefore, this central core will provide the link between various projects and successfully co-ordinate the clinical study and the proposed correlative science. To aid in achieving these goals. Core A will: monitor the timely conduct of the clinical study and assure progress in tissue collection, processing and usage to co-ordinate interaction between the clinical and correlative science studies (Specific Aim 1); provide necessary resources, fiscal oversight and administrative support for projects and cores (Specific Aim 2); co-ordinate communication, and exchange of data between investigators at various international sites (Specific Aim 3); facilitate intra-programatic interactions, meetings, travel and Internal and External Advisory Committees (Specific Aim 4).

该提案汇集了达纳法伯癌症研究所 (DFCI) 的转化医学专业知识、法国 Intergroupe Francophone du Myeloma (IFM) 的临床研究实力以及英国桑格研究所的基因组学专业知识，为 MM 制定治疗策略。在拟议的国际合作项目中，我们将启动迄今为止最重要的多发性骨髓瘤临床试验，将硼替佐米、来那度胺和地塞米松与大剂量治疗相结合，以期治愈多发性骨髓瘤（项目1）。该试验将提供来自新诊断和统一治疗患者的 1000 个 MM 和正常细胞样本，以全面表征 MM 基因组并定义驱动 MM 发生和进展的分子事件（项目 2）；识别新的治疗靶点和药物（项目 3）和生物标志物（项目 1、2、4）；以及定义 MM 基因组不稳定性的机制和临床意义（项目 4）。该项目研究项目的最终目标是确定肿瘤基因组变化及其与临床结果的关系；识别和开发针对多发性骨髓瘤分子异常的创新疗法。这种独特的协作工作需要大量的工作协调、战略整合、各种职能的监测和监督，以及各个分散地点的调查人员之间的沟通。 Core A 的关键功能是整合研究工作和研究者之间的沟通。科学和行政一体化对于确保四个项目之间以及该跨国多机构项目内和项目之间的实验室和临床组成部分之间的成功互动至关重要。因此，这个核心将提供各个项目之间的联系，并成功协调临床研究和拟议的相关科学。帮助实现这些目标。核心 A 将：监控临床研究的及时进行，并确保组织收集、处理和使用方面的进展，以协调临床和相关科学研究之间的相互作用（具体目标 1）；为项目和核心提供必要的资源、财政监督和行政支持（具体目标 2）；协调不同国际地点的调查人员之间的沟通和数据交换（具体目标 3）；促进计划内互动、会议、旅行以及内部和外部咨询委员会（具体目标 4）。