Core A: Program Management and Biostatistics Core

核心 A：项目管理和生物统计学核心

基本信息

批准号：
10001594
负责人：
Richard Charles Boucher
金额：
$ 21.34万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-07 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10001594
关键词：
Accounting Allergens Animal Model Asses Asthma Basic Science Biological Markers Biological Models Biometry Biostatistics Core Charge Clinical Clinical Data Clinical Research Conflict of Interest Data Data Collection Database Management Systems Databases Decision Making Development Dose Drug Kinetics Drug Modelings Drug Targeting Evaluation Studies Formulation Frequencies Generations Human Resources Hydration status In Vitro Lung diseases MUC5AC gene MUC5B gene Manuscripts Measures Molecular Mucins Mucolytics Mucous body substance Names Pharmacodynamics Preparation Process Program Development Protocols documentation Research Personnel Role Safety Schedule Science Services Study Subject Translating biomarker validation candidate identification clinical candidate clinical database clinical development design drug development human disease human subject novel pharmacokinetics and pharmacodynamics pre-clinical programs translational study trial design

项目摘要

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.

摘要 - 核心A 计划管理和生物统计学核心旨在充当药物开发项目团队决策机构。那将监督药物开发范式的各个方面。这项活动将涉及两个集成和重叠的功能：（1）对科学的新方向进行监督/评估构成TPPG目标/药物开发范式基础的主题；（2）对药物的监督发展过程。对科学范式的监督将集中于理想概况的描述粘液溶剂，需要粘液水合剂与粘液溶剂共进行粘液溶液，选择粘液溶解临床在TPPG开发计划中，候选人以及生物标志物的识别和验证。对药物开发过程的监督将包括对DSMB和DSMB组成的监督宪章，数据流向DSMB，以及DSMB在临床开发决策中的作用。核心遗嘱还为临床项目的临床前项目和广泛的服务提供生物统计援助在创建用于临床数据收集的RedCAP数据库的背景下，对临床数据库的监督管理和创建表和清单，以分析所有研究。注意，外部生物统计学家将由Core A命名，以全面审查安全性和效率数据。外部统计学家也将是外部顾问委员会的一部分。最后，核心A将为TPPG提供管理职能，包括预算和计划支持，对人类主题的监督，协议以及对冲突的冲突兴趣评论。这些活动应为生物统计学核心提供有效的项目管理 TPPG的支持功能。