IGF::OT::IGF SBIR TOPIC 86 PHASE I - CLINICAL TRIALS EDUGAME (CTEG)

鉴于儿童临床试验对普通人群健康和医疗福利的重要性，公众了解儿科CT的工作原理也至关重要。被招募参加研究的儿童被告知有关研究的基本事实，并被要求参与决策过程。对这些儿童及其家庭成员进行有关临床试验的教育至关重要，以便他们在被要求提供参与研究的同意书时能够更充分地理解内容信息。为了满足这一需求，NHLBI发布了SBIR合同请求，以开发经过验证的材料和工具，帮助儿童了解儿科临床研究。这些材料和工具将在NHLBI的儿童和临床研究网站上免费提供，并位于“儿童俱乐部”空间内。NOVA建议在虚拟研究诊所环境中开发一套以网络为基础的互动学习工具，以小学学龄儿童为对象。这些儿童将作为临床试验研究培训生开始学习临床试验和儿科患者的参与，通过拟议的基于网络的教育工具-临床试验教育游戏（CTEG）。了解儿科CT的不同方面以及相关的研究方法需要一个框架，鼓励儿童玩家完成多个学习任务，并在进行过程中获得积极的反馈。

Given the importance of children's clinical trials in terms of the health and medical well-being of the general population, it is also crucial that the public understand how pediatric CTs work. Children who are recruited to participate are given basic facts about the study and asked to be part of the decision-making process. Educating these children and their family members about clinical trials is essential so they can more fully understand content information when being asked to provide assent/consent for participation in a study. To address this need, NHLBI issued an SBIR contract request to develop validated materials and tools to help children learn about pediatric clinical research. These materials and tools will be available free of charge on NHLBI’s Children and Clinical Studies website, to reside within the “Kids Clubhouse” space. NOVA is proposing to develop a web-based interactive learning tool set in a virtual research clinic environment targeted to elementary-school-aged children. These children will start as clinical trials research trainees learning about clinical trials and the participation of pediatric patients through the proposed web-based educational tool—the Clinical Trials Edugame (CTEG). Learning about the different aspects of pediatric CTs as well as associated research methodology requires a framework that encourages child players to travel through multiple learning tasks and receive positive feedback as they proceed.