Rho Federal Systems Division, Inc. NIAID DAIT SACCC

Rho 联邦系统部, Inc. NIAID DAIT SACCC

基本信息

批准号：
10823519
负责人：
Gloria David
金额：
$ 280万
依托单位：
RHO FEDERAL SYSTEMS DIVISION, INC.
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-05-07 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10823519
关键词：
Allergic Disease Applied Research Area Asthma Autoimmune Autoimmune Diseases Award Basic Science Biological Specimen Banks Clinical Clinical Investigator Clinical Research Clinical Trials Data Monitoring Committees Collaborations Collection Communicable Diseases Communication Contracts Data Data Analyses Data Collection Data Reporting Dedications Development Disease Ensure Ethics Event Health Human Resources Hypersensitivity Immune System Diseases Immunology Individual Infrastructure Laboratories Management Information Systems Mission Monitor National Institute of Allergy and Infectious Disease Organ Transplant Research Patients Preparation Procedures Process Protocols documentation Publications Randomized Recommendation Reporting Research Research Personnel Research Support Resources Safety Scientist Secure Serious Adverse Event Services Solid Standardization Statistical Data Interpretation Structure Study Subject System Technology Testing Transplantation Work Writing clinical research site clinical training data management design experience high dimensionality improved instrument meetings member patient safety performance site prevent programs protocol development research study rho sample collection statistics success tool

项目摘要

This project is a one-year extension of the consolidated DAIT Statistical and Clinical Coordinating Center (DAIT SACCC). The extension will enable crucial continuity of services while the individual successor contracts assuming the work of the DAIT SACCC are awarded and any necessary transitions occur. The DAIT SACCC supports research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. The objective of the DAIT SACCC is to provide efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, clinical site monitoring, ancillary services, data management, and safety oversight. During the extension, the DAIT SACCC will continue to (1) provide staff experienced in research conducted by DAIT-supported consortia and organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research consortia and DAIT, and facilitates communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and DAIT officials, design and analyze studies across the full scope of research; (3) facilitate the development, review, and revision of protocols and protocol-related documents through dedicated protocol teams; (4) provide study initiation and study management functions required for the efficient, valid, and ethical conduct of studies; (5) provide well-developed procedures and personnel for the monitoring of clinical sites; (6) provide efficient and accurate tracking and reconciliation of specimen collection and distribution; (7) provide integrated and secure information management systems and procedures for the collection of clinical and mechanistic data; (8) help ensure patient safety by providing high-quality serious adverse event (SAE) reporting and Data and Safety Monitoring Board (DSMB) reports; and (9) provide tools, infrastructure, and analytical support in the planning, implementation, analysis, and dissemination of high dimensional mechanistic studies.

该项目是合并后的 DAIT 统计和临床协调中心的一年延伸（DAIT SACCC）。延期将确保服务的关键连续性，而个人继任者授予承担 DAIT SACCC 工作的合同并发生任何必要的过渡。这 DAIT SACCC 支持哮喘和过敏性疾病、自身免疫性疾病和移植。 DAIT SACCC 的目标是提供以下方面的有效协调：服务：方案开发、研究启动和管理、统计设计和分析、临床现场监控、辅助服务、数据管理和安全监督。在延期期间，DAIT SACCC 将继续 (1) 提供在 DAIT 支持的联盟进行的研究方面经验丰富的工作人员并将这些工作人员组织在一个能够有效管理资源的行政结构中，对研究联盟和 DAIT 的需求，并促进沟通与协作； (2) 提供经验丰富的科学家和统计学家与临床研究人员和 DAIT 官员合作，设计和分析整个研究范围的研究； (3) 促进开发、审查和通过专门的方案团队修订方案和方案相关文件； (4) 提供学习高效、有效和合乎道德的研究行为所需的启动和研究管理职能； (5) 提供完善的临床场所监测程序和人员； (6)提供高效准确跟踪和核对标本采集和分发； (7) 提供集成和用于收集临床和机械数据的安全信息管理系统和程序； (8) 通过提供高质量的严重不良事件 (SAE) 报告和数据，帮助确保患者安全和安全监察委员会 (DSMB) 报告； (9) 提供工具、基础设施和分析支持高维机制研究的规划、实施、分析和传播。

项目成果

期刊论文数量（74）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone.

DOI：
10.1111/bjd.13350
发表时间：
2015-03
期刊：
The British journal of dermatology
影响因子：
0
作者：
Hall RP 3rd;Fairley J;Woodley D;Werth VP;Hannah D;Streilein RD;McKillip J;Okawa J;Rose M;Keyes-Elstein LL;Pinckney A;Overington A;Wedgwood J;Ding L;Welch B
通讯作者：
Welch B

Clinical and Molecular Findings After Autologous Stem Cell Transplantation or Cyclophosphamide for Scleroderma: Handling Missing Longitudinal Data.

自体干细胞移植或环磷酰胺治疗硬皮病后的临床和分子发现：处理缺失的纵向数据。

DOI：
10.1002/acr.24785
发表时间：
2023
期刊：
Arthritis care & research
影响因子：
4.7
作者：
Keyes-Elstein,Lynette;Pinckney,Ashley;Goldmuntz,Ellen;Welch,Beverly;Franks,JenniferM;Martyanov,Viktor;Wood,TammaraA;Crofford,Leslie;Mayes,Maureen;McSweeney,Peter;Nash,Richard;Georges,George;Csuka,ME;Simms,Robert;Furst,Danie
通讯作者：
Furst,Danie

Impact of Past Research Experience on Subsequent Trials: A Caution.

过去的研究经验对后续试验的影响：警告。

DOI：
10.1164/rccm.201905-0926le
发表时间：
2020
期刊：
American journal of respiratory and critical care medicine
影响因子：
24.7
作者：
Villarreal,MiguelA;Wildfire,JeremyJ;Sorkness,ChristineA;Gergen,PeterJ;Visness,CynthiaM;Mitchell,HermanE
通讯作者：
Mitchell,HermanE

Pathways through which asthma risk factors contribute to asthma severity in inner-city children.

哮喘危险因素导致内城区儿童哮喘严重程度的途径。

DOI：
10.1016/j.jaci.2016.06.060
发表时间：
2016-10
期刊：
The Journal of allergy and clinical immunology
影响因子：
0
作者：
Liu AH;Babineau DC;Krouse RZ;Zoratti EM;Pongracic JA;O'Connor GT;Wood RA;Khurana Hershey GK;Kercsmar CM;Gruchalla RS;Kattan M;Teach SJ;Makhija M;Pillai D;Lamm CI;Gern JE;Sigelman SM;Gergen PJ;Togias A;Visness CM;Busse WW
通讯作者：
Busse WW

Calabrese et al. Respond.

卡拉布雷斯等人。