Clinical Core

临床核心

• 批准号: 10715743
• 负责人: Rebecca R. Richards-Kortum
• 金额: $ 36.39万
• 依托单位: RICE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10715743
• 关键词: Acceleration; Address; Adopted; Adoption; Africa; Animals; Benchmarking; Biometry; Brazil; Budgets; Caring; Cessation of life; Characteristics; China; Clinic; Clinical; Clinical Trials; Collaborations; Communities; Community Health Aides; Comparative Biology; Country; Development; Devices; Diagnosis; Disease; Early Diagnosis; Effectiveness; Engineering; Ensure; Environmental Exposure; Equity; Europe; Evaluation; Face; Family; Feedback; Genetic; Goals; Health system; Healthcare; Home; Income; India; Infrastructure; Instruction; International; Laboratories; Latin America; Lesion; Malignant Neoplasms; Medical center; Medicine; Morbidity - disease rate; Mozambique; Pathologist; Pathology; Patients; Performance; Point of Care Technology; Population Heterogeneity; Prevention; Prevention strategy; Provider; Race; Research; Research Design; Research Personnel; Resource-limited setting; Resources; Screening for cancer; Services; System; Technology; Texas; Translating; Translations; Validation; Veterinarians; Visit; Work; cancer care; cancer health disparity; cancer prevention; college; commercialization; cost effective; cost effectiveness; design; experience; implementation evaluation; implementation facilitation; implementation facilitators; implementation outcomes; improved; innovation; low and middle-income countries; models and simulation; mortality; multidisciplinary; point of care testing; premalignant; prototype; recruit; research clinical testing; scale up; screening; simulation; socioeconomics; technology development; technology validation; tool; underserved area; usability

Abstract: Cancer is projected to be the leading cause of global mortality over the next decade and >75% of cancer deaths will occur in LMICs. Moreover, underserved areas face disproportionately higher cancer‐related morbidity, in large part due to inadequate screening and prevention. Lack of access results in initial diagnosis at an advanced and/or incurable stage. There is a great need to develop affordable, accurate POC tests for cancer screening and early cancer detection that can be used by local providers and community health workers, and even by patients and families in their homes. There is an equally great need to validate these technologies in racially and socio‐economically diverse populations and in lower resource settings, with all their environmental and cultural challenges. Indeed, cancer preventive strategies that work in HICs often fail in LMICs (and underserved areas of high‐income countries) due to differences in disease characteristics, health system capacities, environmental (and environmental exposure) differences, as well as racial and genetic differences. The primary goal of the Clinical Core (CC) is to serve as a “clinical laboratory for innovators” by providing infrastructure and services to support clinical validation of POC technologies and to evaluate implementation outcomes for equitable cancer care. The CC will collaborate to validate prototype technologies and establish feasibility and adoption of these devices in a diverse array of appropriate settings. The first aim of the CC is to evaluate clinical performance, effectiveness, and usability of prototype POC technologies for cancer early detection in real‐world clinical settings, including technologies to address cancer health disparities. The second aim is to evaluate implementation of POC technologies for cancer prevention and early detection, including clinical impact, cost effectiveness and barriers/facilitators to implementation in diverse clinical settings. Our multidisciplinary team (clinical researchers, engineers, pathologists, biostatisticians, veterinarians, research coordinators and regulatory managers) has worked collaboratively for > 15 years on five continents, translating technologies from the bench to animal studies and clinical trials in the USA, China, India, Africa, Europe and Latin America. We will bring this wealth of experience to facilitate POC technology validation in highly diverse global settings (US, Mozambique, Brazil etc.). Likewise, we will leverage the core support of the Texas Medical Center and Baylor (simulation, biostatistics, comparative biology/animal) to provide a clinical core that provides high quality support, in both depth (translation, validation, regulatory) and breadth (international). Through these aims, the CC will work with other CITEC cores to evaluate and advance a robust pipeline of POC technologies for equitable cancer care by identifying high priority unmet screening and early detection needs and ensuring that high impact technologies are developed, translated and evaluated in a rigorous and safe way that allows implementation, commercialization and scale‐up.

抽象的： 预计癌症将成为未来十年全球死亡的主要原因，并且超过 75% 的癌症死亡将发生 此外，在中低收入国家，服务不足的地区面临着不成比例的较高癌症相关发病率，这在很大程度上是由于 缺乏适当的筛查和预防会导致初步诊断已处于晚期和/或无法治愈的阶段。 非常需要开发负担得起的、准确的 POC 测试来进行癌症筛查和早期癌症检测， 供当地提供者和社区卫生工作者，甚至患者和家庭在家中使用。 同样迫切需要在种族和社会经济多样化的人群以及较低的人群中验证这些技术 资源环境及其所有环境和文化挑战确实有效的癌症预防策略。 由于疾病特征的差异，高收入国家经常在中低收入国家（以及高收入国家的服务欠缺地区）失败， 卫生系统能力、环境（和环境暴露）差异以及种族和遗传 临床核心 (CC) 的主要目标是通过提供服务来充当“创新者的临床实验室”。 支持 POC 技术临床验证并评估实施结果的基础设施和服务 CC 将合作验证原型技术并确定可行性和采用。 CC 的首要目标是评估这些设备在各种适当环境中的临床表现， 原型 POC 技术在现实临床环境中用于癌症早期检测的有效性和可用性， 包括解决癌症健康差异的技术第二个目标是实施 POC 评估。 癌症预防和早期检测技术，包括临床影响、成本效益和 我们的多学科团队（临床研究人员、 工程师、病理学家、生物统计学家、兽医、研究协调员和监管经理）都曾工作过 在五大洲合作超过 15 年，将技术从实验室转化为动物研究和临床 我们将在美国、中国、印度、非洲、欧洲和拉丁美洲进行试验，以促进 POC。 同样，我们将利用核心技术在高度多样化的全球环境中进行技术验证（美国、莫桑比克、巴西等）。 德克萨斯医学中心和贝勒大学的支持（模拟、生物统计学、比较生物学/动物）提供临床 提供深度（翻译、验证、监管）和广度（国际）高质量支持的核心。 通过这些目标，CC 将与其他 CITEC 核心合作，评估和推进强大的 POC 技术管道 通过确定高度优先的未满足筛查和早期检测需求并确保高度重视来实现公平的癌症护理 影响技术以严格和安全的方式开发、翻译和评估，以便实施、 商业化和规模化。