Administrative and Communication Core

行政和沟通核心

• 批准号: 8566800
• 负责人: Nikhil C. Munshi
• 金额: $ 17.08万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8566800
• 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).

这项建议结合了Dana-Farber癌症研究所(DFCI)的转化医学专业知识和法国骨髓瘤国际集团(IFM)的临床研究实力，以及英国桑格研究所(Sanger Institute)的基因组学专业知识，以制定MM的治疗策略。在拟议的国际合作项目中，我们将启动迄今最重要的MM临床试验，将Bortezomib、来那度胺和地塞米松与高剂量治疗相结合，努力寻求MM的治愈(项目1)。这项试验将提供来自新诊断和统一治疗的患者的1000个MM和正常细胞样本，以全面描述MM基因组并确定推动MM发展和进展的分子事件(项目2)；确定新的治疗靶点和制剂(项目3)和生物标记物(项目1、2、4)；以及确定MM基因组不稳定的机制和临床意义(项目4)。该计划研究项目的最终目标是确定肿瘤基因组的变化及其与临床结果的关系；并确定和开发针对MM分子异常的创新疗法。这一独特的合作努力需要大量的努力协调，策略的整合，对各种功能的监测和监督，以及不同分散地点的研究人员之间的沟通。核心A的关键功能是整合研究努力和调查人员之间的沟通。科学和行政一体化对于确保四个项目之间的成功互动以及这一跨国多机构计划中项目内和项目之间的实验室和临床组件之间的成功互动至关重要。因此，这个中心核心将提供各种项目之间的联系，并成功地协调临床研究和拟议的相关科学。以帮助实现这些目标。核心A将：监测临床研究的及时进行，并确保组织收集、加工和使用方面的进展，以协调临床和相关科学研究之间的互动(具体目标1)；为项目和核心提供必要的资源、财政监督和行政支助(具体目标2)；协调各国际地点研究人员之间的沟通和数据交换(具体目标3)；促进方案内互动、会议、旅行以及内部和外部咨询委员会(具体目标4)。