Clinical Core

摘要： 癌症预计将是未来十年全球死亡的主要原因，75%的癌症死亡将发生在癌症死亡中 在LMIC中。此外，服务不足的地区面临不成比例的高癌症相关发病率，这在很大程度上是由于 筛查和预防不力。缺乏机会会导致在晚期和/或不治之症阶段的初步诊断。 非常需要为癌症筛查和早期癌症检测开发负担得起的、准确的POC测试，这些测试可以 可供当地医疗服务提供者和社区卫生工作者使用，甚至可供病人和家属在家使用。有一个 同样迫切需要在种族和社会经济不同的人群以及较低的人口中验证这些技术 资源环境及其带来的所有环境和文化挑战。事实上，癌症预防策略在 由于疾病特征的差异，低收入国家(和高收入国家服务不足地区)的艾滋病毒/艾滋病常常失败， 卫生系统能力、环境(和环境暴露)差异以及种族和遗传 不同之处。临床核心(CC)的主要目标是通过提供 基础设施和服务，以支持POC技术的临床验证并评估实施结果 为了公平的癌症护理。CC将合作验证原型技术，并确定可行性和采用率 在不同的适当设置阵列中。CC的第一个目标是评估临床表现， 在真实世界临床环境中用于癌症早期检测的原型POC技术的有效性和可用性， 包括解决癌症健康差距的技术。第二个目标是评估POC的实施情况 癌症预防和早期发现技术，包括临床影响、成本效益和 在不同的临床环境中实施的障碍/促进者。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)发挥了作用 在五大洲合作了15年，将技术从工作台转化为动物研究和临床 在美国、中国、印度、非洲、欧洲和拉丁美洲进行试验。我们将利用这些丰富的经验来促进PoC 在高度多样化的全球环境中(美国、莫桑比克、巴西等)进行技术验证。同样，我们将利用核心 支持德克萨斯医学中心和贝勒(模拟、生物统计学、比较生物学/动物)提供临床 在深度(翻译、验证、监管)和广度(国际)方面提供高质量支持的核心。 通过这些目标，协调委员会将与其他CITEC核心合作，评估和推进POC技术的强大管道 通过确定未得到满足的高优先级筛查和早期发现需求，并确保高优先级的 以严格和安全的方式开发、转换和评估影响技术，使其能够实施， 商业化和规模化。

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.