OTHER FUNCTIONS - SBIR PHASE II: TOPIC 53, INNOVATIVE TOOLS, TECHNIQUES AND SOFT

筛选和招募儿童进入多中心临床试验带来了在成人人群中看不到的独特挑战。需要筛选工具、招募策略、登记以提供未来临床试验所依据的基线数据，以及记录随访的方法。适用于不同人群和用于社区实践的经过验证的材料和工具尤其重要，因为社区实践往往没有大型医院或学术机构的资源。这些工具应适用于广泛的儿科心脏，肺，血液和睡眠障碍研究，并将开发以提高临床试验性能。最终目标是通过作为开源产品向公众提供的工具或策略，使试验招募和管理更加高效和有效。 工具不限于，但可以包括： 针对年龄较大的儿童和青少年的互动游戏策略，有可能激发他们对与心脏，肺，血液和睡眠障碍有关的科学研究领域的兴趣。这是一种创新且经过验证的方式，可以吸引用户（特别是年轻人）并提供基本的健康信息，例如临床研究在改善健康方面的重要性，加入研究时所涉及的内容，并突出国家心脏，肺和血液研究所（NHLBI）在生物医学研究中的作用。 <$先天性心脏病登记的基础设施开发，如病例报告表、基于网络的门户网站的开发以及可持续运营的需求评估（人力、维护、IT支持等）。后端业务活动可包括评估现有信息系统，开发软件以促进现有系统的互操作性，开发可从现有电子病历和/或电子监测系统提取数据的软件，以及开发可从各种来源提取数据的灵活数据库平台。 临床试验参与者的提醒工具，教育资源（小册子，公共网站），新颖和改进的同意工具（表格，视频，基于网络），以及研究者或申办者可以轻松使用的临床试验成本评估工具。 促进采用循证指南的方法。 第一阶段研究的重点是开发新技术或策略，以提供原型的初步测试，并证明它将如何改善儿科试验招募或试验管理。 第二阶段研究将进一步完善技术或策略，并测试其有效性，以纳入临床研究环境。

Screening and recruitment of children into multi-center clinical trials poses unique challenges not seen in the adult population. Screening tools, recruitment strategies, registries to provide baseline data on which to base future clinical trials and ways to document follow-up are needed. Validated materials and tools applicable to diverse populations and for use in community practices, which often do not have the resources of larger hospitals or academic institutions, are particularly relevant. These tools should apply to a wide range of pediatric heart, lung, blood, and sleep disorders studies and would be developed to improve clinical trial performance. The ultimate goal is to make trial recruitment and management more efficient and effective via tools or strategies offered to the public as an open-source product. Tools are not limited to, but can include: ¿ Interactive gaming strategies for older children and adolescents that have the potential to stimulate interest in scientific research areas related to heart, lung, blood and sleep disorders. This is an innovative and proven way to engage users (particularly youth) and deliver essential health messages, such as the importance of clinical research in improving health, what is involved when one joins a study, and to highlight the role of National Heart, Lung, and Blood Institute (NHLBI) in biomedical research. ¿ Infrastructure development for a registry in congenital heart disease such as case report forms, development of a web-based portal, and needs assessment for sustainable operation (manpower, maintenance, IT support, etc.). Activities for back end operations could include assessment of existing information systems, development of software to facilitate interoperability of current systems, development of software that can extract data from current electronic medical records and/or electronic monitoring systems, and development of a flexible database platform that can draw data from varied sources. ¿ Reminder tools for clinical trial participants, educational resources (pamphlets, public websites), novel and improved consent tools (forms, videos, web-based), and clinical trial costs assessment tools that can be easily used by investigators or sponsors. ¿ Approaches to facilitating adoption of evidence-based guidelines. Phase I research focused on development of a new technology or strategy, to provide initial testing of the prototype and demonstrate how it will improve pediatric trial recruitment or trial management. Phase II studies will further refine the technology or strategy and test its effectiveness for incorporation into the clinical research setting.