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.
