I-Corps: Clinical trial safety

I-Corps：临床试验安全

• 批准号: 2302093
• 负责人: Elizabeth Johnson
• 金额: $ 5万
• 依托单位: Montana State University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2302093&HistoricalAwards=false
• 关键词: Corps; Clinical; trial; safety

The broader impact/commercial potential of this I-Corps project is the development of an innovation for community providers providing direct access to clinical trial safety information when developing a plan of care for a trial participant outside of the research setting, including which medicines and treatments to explicitly avoid. Approximately 1 in 50 children and hundreds of adults enrolled in clinical trials (particularly in oncology) experience a fatal drug interaction, largely attributed to lack of trial details at time of clinical encounter. This innovation has the potential to improve the well-being of individuals by support and inform current policy initiatives aiming to expand availability of clinical trial opportunities for adult and pediatric patients, such as by easing travel burdens associated with clinical trial visits and procedures. As a mobile, bridging technology that can span any distance and be accessed by any provider, this innovation can bolster expanded clinical trial access for individuals and communities in rural settings, who may otherwise be unable to participate (or risk injury by accessing care in an uninformed setting) and will thus broaden participation of underrepresented minorities in science. This I-Corps project is based on the development of a new product that addresses the challenges of clinical trial management by leveraging wearable technology and embedded software to provide real-time safety information for participants. This use-inspired solution represents the convergence of disparate fields, including engineering (human factors, ergonomics), computer science (user experience, human-centered computing), and nursing models of patient care (clinical outcomes). Preliminary data demonstrate that clinical nurses have a high knowledge deficit related to the unique care needs of clinical trial participants and do not screen for such needs during assessments. This innovation catalyzes opportunities for open information exchange that will broaden healthcare providers’ knowledge of drug testing safety and improve clinical care outcomes. Through the integration of trial safety information (drug interactions with standard of care treatments, side effect profiles, research team contact information) and related increase in trial participant retention, this product will accelerate the scientific understanding needed to develop novel therapeutics while positively altering the pharmaceutical industry research paradigm related to equitable, inclusive, and accessible safety management.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个i-Corps项目的更广泛的影响/商业潜力是为社区提供者开发一种创新，在为研究环境之外的试验参与者制定护理计划时，提供直接访问临床试验安全信息的途径，包括明确避免哪些药物和治疗。在参加临床试验(特别是肿瘤学)的儿童和成人中，大约每50人中就有1人经历了致命的药物相互作用，这主要是由于在临床遇到时缺乏试验细节。这一创新有可能通过支持和宣传旨在扩大成人和儿科患者临床试验机会的当前政策举措，例如通过减轻与临床试验访问和程序相关的旅行负担，来改善个人的福祉。作为一种移动的桥梁技术，可以跨越任何距离，任何提供者都可以访问，这项创新可以支持农村地区的个人和社区扩大临床试验机会，否则他们可能无法参与(或在不知情的情况下获得护理而冒着受伤的风险)，从而扩大代表不足的少数群体对科学的参与。这个i-Corps项目是基于开发一种新产品，通过利用可穿戴技术和嵌入式软件为参与者提供实时安全信息来应对临床试验管理的挑战。这一以使用为灵感的解决方案代表了不同领域的融合，包括工程学(人类因素、人体工程学)、计算机科学(用户体验、以人为中心的计算)和患者护理模型(临床结果)。初步数据显示，临床护士缺乏与临床试验参与者的独特护理需求相关的高度知识缺陷，并且在评估过程中没有对这种需求进行筛选。这一创新促进了开放信息交流的机会，这将拓宽医疗保健提供者对药物测试安全性的知识，并改善临床护理结果。通过整合试验安全信息(药物与护理标准治疗的相互作用、副作用概况、研究团队联系信息)以及试验参与者留存的相关增加，该产品将加速开发新疗法所需的科学理解，同时积极改变与公平、包容和可获得的安全管理相关的制药业研究范式。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。