Core A: Program Management and Biostatistics Core

抽象-核心A 项目管理和生物统计核心旨在发挥药物开发项目团队的作用 决策机构。因此，它将监督药物开发范例的所有方面。本练习将 涉及两个综合和重叠的职能：(1)监督/评估科学研究的新方向 构成tPPG目标/药物开发范例基础的专题；和(2)药物监督 发展进程。对科学范例的监督将侧重于描绘 粘液剂，与粘液剂共配制的粘液水合剂的需要，粘液剂临床的选择 候选，以及在整个tPPG开发计划中使用的生物标记物的识别和验证。 对药物开发过程的监督将包括对药物管理和药物管理的组成的监督。 宪章，数据流到dsmb，以及dsmb在临床开发决策中的作用。核心A将 为临床前期项目提供生物统计学帮助，为临床项目提供广泛的服务 在为临床数据收集创建RedCap数据库的背景下，对临床数据库的监督 管理，并创建表格和清单，用于所有研究的分析。注意，一位外部生物统计学家 将由Core A指定用于安全性和有效性数据的全面最终审查。外部统计员也将 外部咨询委员会的一部分。最后，核心A将向tPPG提供行政职能，包括 预算和方案支助、对人类主体、方案的监督以及对冲突的监督 利息评论。这些活动应为生物统计核心领域提供有效的项目管理 支持tPPG功能。

Abstract – Core A The Program Management and Biostatistics Core is designed to function as a drug development Project Team decision-making body. Thus, it will oversee all aspects of the drug development paradigm. This activity will involve two integrated and overlapping functions: (1) Oversight/Assessment of new directions of the scientific topics that form the basis of the tPPG target/drug development paradigm; and (2) Oversight of the drug development process. The oversight of scientific paradigms will focus on delineation of the ideal profile for mucolytics, need for mucus hydrating agents for co-formulation with mucolytics, selection of mucolytic clinical candidates, and identification and validation of biomarkers for use throughout the tPPG development program. Oversight of the drug development process will include oversight of the composition of the DSMB and DSMB Charter, flow of data to the DSMB, and the role of DSMB in clinical development decision making. Core A will also provide biostatistical assistance to the pre-clinical projects and extensive services for the clinical projects in the context of the creation of REDCap databases for clinical data collection, oversight of clinical database management , and creation of tables and listings for analyses of all studies. Note, an external biostatistician will be named by Core A for overall final review of safety and efficacy data. The external statistician will also be part of the External Advisory Board. Finally, Core A will provide administrative functions to the tPPG, including budgetary and programmatic support, oversight of human subjects, protocols, and oversight of conflict of interest reviews. These activities should provide for an effective Project Management in Biostatistics Core support function for the tPPG.