Clinical-Trans-Valid Core

临床验证核心

• 批准号: 9973117
• 负责人: Chad J Achenbach
• 金额: $ 54.14万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9973117
• 关键词: AIDS related cancer; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adoption; Africa; Back; Biological Markers; Biomedical Engineering; Care Technology Points; Caregivers; Caring; Characteristics; Clinical; Clinical Investigator; Clinical Research; Communicable Diseases; Communities; Development; Diagnosis; Disease; Emergency Situation; Engineering; Ensure; Evaluation; Faculty; Funding; Goals; Gold; Grant; HIV; Individual; Infrastructure; Institution; International; International AIDS; Laboratories; Leadership; Mali; Manuals; Measures; Medical Education; Methodology; Mycobacterium africanum; Nigeria; Outcome; Performance; Process; Public Health; Recording of previous events; Research; Research Design; Research Personnel; Research Training; Resources; Services; Site; South Africa; Tanzania; Technology; Testing; Training; Training Programs; Translations; United States National Institutes of Health; Universities; Validation; Work; base; clinical implementation; clinical practice; clinical research site; clinical translation; comorbidity; epigenomics; experience; implementation science; innovation; international center; low and middle-income countries; mycobacterial; new technology; pathogen; programs; prototype; success; technology development; technology training; tool; uptake; validation studies

SUMMARY – CLINICAL TRANSLATION AND VALIDATION CORE The C-THAN Clinical Translation and Validation Core (Clinical Trans Valid Core) will be robust and achievable due to many years of HIV-focused clinical research and research training with local partners in Nigeria, South Africa, Mali, and Tanzania. In addition to our key academic partners, we will integrate many other international, national, regional and community stakeholders involved in POC development, validation, and implementation across the partner institutions. Our overarching objective is to develop a pipeline of POC products that meet the clinical needs of HIV-infected individuals in low and middle-income countries. Investigators will be required to demonstrate analytical and clinical performance of technologies as well as suitability and feasibility of use in low resource settings. The Clinical Trans Valid Core specific aims are: 1. validate and establish best practices for innovative POC technologies developed for the diagnosis and management of HIV and HIV related co- morbidities in “real-world” clinical or public health settings, 2. assess outcomes of implementation processes of innovative POC technologies developed for the diagnosis and management of HIV and HIV related co- morbidities in “real-world” clinical or public health settings, and 3. support translation of innovative POC technologies from the Technology Development (Technology Dev) Core into clinical practice though pilot funding, expertise in validation and implementation science, and providing resources including support to develop needed trainings, manuals and other tools to ensure effective uptake. Our Clinical Trans Valid Core will provide a “clinical laboratory” for innovators that will focus on validation, adoption, and assessment of feasibility and implementation of POC technologies. Depending on the status of a developing POC technology, we will work across Cores to select projects to participate in either the Clinical Trans Valid Core or Technology Dev Core. We will also review projects in the Technology Dev Core in later stages for potential transition into the Clinical Trans Valid Core. The primary goal of the Clinical Trans Valid Core is to provide infrastructure and services dedicated to clinical validation of POC technologies and to evaluate implementation outcomes including adoption, fidelity, feasibility and acceptability to ensure that POC technology prototypes supported under C-THAN will have a high rate of success for clinical uptake and maximal public health impact.

摘要-临床翻译和验证核心 C-THAN临床翻译和验证核心（临床翻译有效核心）将是稳健和可实现的 由于多年来与尼日利亚当地合作伙伴开展的以艾滋病毒为重点的临床研究和研究培训， 非洲马里和坦桑尼亚除了我们的主要学术合作伙伴，我们将整合许多其他国际， 参与POC开发、验证和实施的国家、地区和社区利益相关者 在合作机构中。我们的总体目标是开发一系列符合以下要求的POC产品： 低收入和中等收入国家艾滋病毒感染者的临床需求。将要求研究者 证明技术的分析和临床性能以及用于以下方面的适用性和可行性： 低资源设置。临床跨有效的核心具体目标是：1。验证和建立最佳做法 用于诊断和管理艾滋病毒和艾滋病毒相关疾病的创新POC技术， 在“真实世界”的临床或公共卫生环境中的发病率，2.评估实施过程的结果 为诊断和管理艾滋病毒和艾滋病毒相关疾病而开发的创新POC技术， 在“真实世界”临床或公共卫生环境中的发病率，以及3.支持创新POC翻译 通过试点将技术从技术开发（技术开发）核心转化为临床实践 资金、验证和实施科学方面的专门知识，并提供资源，包括支持 制定所需的培训、手册和其他工具，以确保有效的吸收。我们的临床跨有效核心 将为创新者提供一个“临床实验室”，重点是验证、采用和评估 POC技术的可行性和实施。根据正在发展的POC的状态， 技术，我们将跨核心工作，以选择项目参与临床跨有效核心或 技术开发核心。我们还将在后期阶段审查技术开发核心中的项目， 过渡到临床Trans Valid核心。临床跨有效核心的主要目标是提供 致力于POC技术临床验证和评估实施的基础设施和服务 结果包括采用、保真度、可行性和可接受性，以确保POC技术原型 在C-THAN支持下，将有很高的临床应用成功率和最大的公共卫生影响。