IPP: AUTOIMMUNE DISEASES STATISTICAL AND CLINICAL COORDINATING CENTER (ADSCCC)

IPP：自身免疫性疾病统计和临床协调中心 (ADSCCC)

• 批准号: 10688713
• 负责人: CHRISTINA MILLIN
• 金额: $ 400万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10688713
• 关键词: Autoimmune Diseases; Clinical; Clinical Management; Clinical Research; Clinical Trials; Collaborations; Development; Disease; Genetic study; Immunology; Investigation; Manuscripts; Mucous Membrane; Phase; Preparation; Prevention; Safety; Sampling; Support Contracts; Surrogate Markers; Surveys; congenital immunodeficiency; design; innovation; microbiome research; pharmacovigilance; protocol development; repository

Contract supports a broad range of statistical and clinical support for the design, development, execution, and analysis of clinical research in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. Clinical research to be supported includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., genetic studies, microbiome studies, surveys of current therapies, etc.); and (iv) surrogate/biomarker studies. Functions to be performed include statistical design and analysis; protocol development; study initiation and management; clinical safety and pharmacovigilance support; safety oversight; management of clinical study collaboration portals; manuscript preparation and management of sample repositories.

合同支持与粘膜免疫学和原发性免疫缺陷有关的自身免疫性疾病和疾病的临床研究的设计，开发，执行和分析的广泛统计和临床支持。要支持的临床研究包括：（i）在所有阶段进行临床试验，以评估研究产品的安全性和功效以及疾病治疗和预防的创新方法； （ii）将基本机制作为临床试验不可或缺的组成部分的研究； （iii）临床研究（例如，遗传研究，微生物组研究，当前疗法的调查等）； （iv）替代/生物标志物研究。要执行的功能包括统计设计和分析；协议开发；研究启动和管理；临床安全和药物护理支持；安全监督；临床研究合作门户的管理；样品存储库的手稿准备和管理。