Rho Federal Systems Division, Inc. NIAID DAIT SACCC

Rho 联邦系统部, Inc. NIAID DAIT SACCC

• 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
• 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

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DAIT统计和临床协调中心的一年扩展

项目成果

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
• 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

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
• 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

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

Lessons Learned: Early Termination of a Randomized Trial of Calcineurin Inhibitor and Corticosteroid Avoidance Using Belatacept.

• DOI: 10.1111/ajt.14377
• 发表时间: 2017-10
• 期刊: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
• 作者: Newell KA;Mehta AK;Larsen CP;Stock PG;Farris AB;Mehta SG;Ikle D;Armstrong B;Morrison Y;Bridges N;Robien M;Mannon RB
• 通讯作者: Mannon RB