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: 10788032
• 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: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788032
• 关键词: Autoimmune Diseases; Biological Markers; Clinical; Clinical Management; Clinical Research; Clinical Trials; Collaborations; Development; Disease; Genetic study; Immunology; Manuscripts; Mucous Membrane; Phase; Preparation; Prevention; Safety; Sampling; Support Contracts; 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.

Contract为自身免疫性疾病和与粘膜免疫学和原发性免疫缺陷相关的疾病的临床研究的设计、开发、执行和分析提供广泛的统计和临床支持。支持的临床研究包括：（i）在所有阶段进行临床试验，以评估研究产品和创新方法在疾病治疗和预防方面的安全性和有效性;（ii）作为临床试验组成部分的潜在机制研究;（iii）临床研究（例如，遗传学研究、微生物组研究、当前疗法的调查等）;和（iv）替代物/生物标志物研究。 拟履行的职能包括统计设计和分析;方案制定;研究启动和管理;临床安全性和药物警戒支持;安全性监督;临床研究协作门户管理;手稿准备和样本库管理。