Pediatric Preclinical Testing Consortium: Coordinating Center

儿科临床前检测联盟：协调中心

• 批准号: 8967492
• 负责人: Diana M Severynse-Stevens
• 金额: $ 48.77万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-10 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8967492
• 关键词: Address; Administrative Coordination; Bioinformatics; Biological; Cancer Etiology; Cessation of life; Characteristics; Child; Childhood; Childhood Cancer Treatment; Clinical Trials; Collection; Communities; Data; Data Analyses; Data Collection; Development; Dictionary; Elements; Ensure; Exhibits; Funding; General Population; Goals; Human; Leadership; Life; Life Expectancy; Liquid substance; Maintenance; Malignant Childhood Neoplasm; Malignant Neoplasms; Manuals; Manuscripts; Mission; Modeling; Molecular; Patients; Pediatric Oncology; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Pre-Clinical Model; Preclinical Testing; Preparation; Procedures; Process; Program Evaluation; Quality Control; Quality of life; Radiation therapy; Recurrence; Reporting; Research; Research Personnel; Resources; Running; Scientist; Shipping; Ships; Side; Site; Specimen; Statistical Data Interpretation; System; Teleconferences; Test Result; Testing; Therapeutic Agents; Translating; advocacy organizations; cancer therapy; cancer type; clinical practice; data management; drug candidate; effective therapy; flexibility; innovation; meetings; member; operation; pre-clinical; premature; programs; public health relevance; quality assurance; tool; treatment effect; tumor; web page; web site

 DESCRIPTION (provided by applicant): The main goal of the Pediatric Preclinical Testing Consortium (PPTC) is to develop models that will translate to human clinical practice and effectively prioritize therapies for the treatment of pediatric cancers. An effective Coordinating Center (CC) will be critical to the Consortium's goals by providing broad organizational, scientific, and analytic expertise to support NCI scientists and the PPTC Research Programs. The CC will also be responsible for developing, implementing, and evaluating a comprehensive PPTC research program, providing leadership in data collection and ongoing program evaluation to ensure that the research program is making optimal progress toward the PPTC mission. Providing the organizational and administrative leadership necessary to enable the Consortium to function efficiently will also be a key function of the CC. RTI's goal as the proposed CC for the PPTC over the next 5 years is to optimize Consortium progress in generating reliable data to accelerate the development of more effective treatments for children with cancer by achieving the following specific aims: 1. Guide interactions between Consortium members and the pediatric oncology community at large. Provide the logistical support necessary to run an efficient and productive Consortium through effective teleconferences, webinars, Consortium meetings, and websites, both public and restricted. Employ these tools to facilitate interactions between PPTC members, pediatric clinicians, pharmaceutical companies, and pediatric oncology advocacy organizations to ensure that promising new therapies are utilized efficiently. 2. Generate reliable data that can be used for prioritization of the therapeuic agents in pediatric cancer. Provide efficient and robust procedures for data collection, statistica analysis of data collected from the Research Programs, and bioinformatic analysis of testing results that can relate treatment effects to molecular characteristics of the preclinical models utilized. 3. Provide the Consortium with a comprehensive, yet flexible set of scientific, statisticl and analytic resources needed to develop an innovative research program for creating a functional Consortium for pediatric preclinical testing. Develop tools to track the status of each potential drug candidate through the preclinical process. Document variables in a Consortium-side data dictionary as one element to build the data management system in REDCap.

 描述(由申请人提供)：儿科临床前测试联盟(PPTC)的主要目标是开发可转化为人类临床实践的模型，并有效地优先治疗儿科癌症。一个有效的协调中心(CC)将通过提供广泛的组织、科学和分析专业知识来支持NCI科学家和PPTC研究计划，从而对联盟的目标至关重要。CC还将负责制定、实施和评估全面的PPTC研究计划，在数据收集和持续计划评估方面提供领导，以确保研究计划朝着PPTC任务取得最佳进展。提供必要的组织和行政领导，使财团能够有效运作，也将是协调委员会的一项关键职能。RTI作为未来5年PPTC的拟议CC，其目标是通过实现以下具体目标，优化联合会在生成可靠数据方面的进展，以加速开发更有效的儿童癌症治疗方法：1.指导联合会成员与整个儿科肿瘤学社区之间的互动。通过有效的电话会议、网络研讨会、联盟会议和网站(包括公开的和受限的)，提供有效运行联盟所需的后勤支持。利用这些工具促进PPTC成员、儿科临床医生、制药公司和儿科肿瘤学倡导组织之间的互动，以确保有效利用有前景的新疗法。2.产生可靠的数据，可用于确定儿童癌症治疗药物的优先顺序。为数据收集、从研究计划收集的数据进行统计分析，以及对检测结果进行生物信息学分析提供高效和可靠的程序，这些检测结果可以将治疗效果与所使用的临床前模型的分子特征联系起来。3.为该联盟提供一套全面而灵活的科学、统计和分析资源，以开发一项创新的研究计划，为儿科临床前试验创建一个功能性联盟。开发工具以跟踪每个潜在候选药物在临床前过程中的状态。将变量作为一个元素记录在联合方数据字典中，以构建RedCap中的数据管理系统。