Clinical Outcome Assessments for Acute Pain Therapeutics in Infants and young Children (COA APTIC)

婴幼儿急性疼痛治疗的临床结果评估 (COA APTIC)

• 批准号: 10778757
• 负责人: Bryce B Reeve
• 金额: $ 118.97万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-06 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10778757
• 关键词: Clinical; Outcome; Assessments; Acute; Pain

ABSTRACT A major barrier to the identification, development, and regulatory approval of therapeutics for treatment of acute pain in infants and young children is the lack of standardized, high-quality measures and endpoints for use in clinical trials. To address this need, Drs. Zimmerman and Reeve will leverage existing infrastructure of the Pediatric Trials Network and the Duke Center for Health Measurement. This partnership capitalizes on strong expertise in pediatric drug development, design and successful execution of pediatric clinical trials, evaluation of analgesic safety and efficacy in children, and design and evaluation of high-quality clinical outcome assessments (COAs). Drs. Zimmerman and Reeve will lead a team of uniquely-qualified investigators in the identification of high quality COAs and endpoints for use in the development of acute pain therapeutics in infants and young children, with a primary focus on those 0-2 years. Specifically, the research team will accomplish the following goals: 1) conduct formative research to identify important outcomes for acute pain drug trials that matter most to patients, caregivers, and clinicians; 2) identify existing COAs for each outcome and determine each COA’s fit-for-purpose for acute pain trials or the need for new COAs; and 3) gather further evidence of the psychometric properties of clinician-, observer-, and patient-reported COAs in a prospective trial among infants and young children. With input from a diverse and well-rounded external technical advisory committee, completion of these goals will help facilitate patient-centered acute pain drug trials and ease the burden of investment in pediatric drug development.

抽象的 鉴定，发育和调节性批准用于治疗婴儿和幼儿急性疼痛治疗的主要障碍是缺乏标准化的高质量测量和用于临床试验的终点。为了满足这一需求，博士。 Zimmerman和Reeve将利用小儿试验网络和杜克大学健康测量中心的现有基础设施。这种合作伙伴关系利用了小儿药物开发，设计和成功执行儿科临床试验的强大专业知识，对儿童的镇痛安全和有效性的评估以及高质量临床结果评估（COA）的设计和评估。博士。齐默尔曼（Zimmerman）和里夫（Reeve）将领导一组独特合格的研究人员，识别出高质量的COA和终点，用于开发婴儿和幼儿的急性疼痛治疗剂，主要关注0 - 2年。具体而言，研究小组将实现以下目标：1）进行形成性研究，以确定对患者，护理人员和临床医生最重要的急性疼痛药物试验的重要结果； 2）确定每个结果的现有COA，并确定每种COA的急性止痛试验或新COA的拟合； 3）在婴儿和幼儿的一项前瞻性试验中，收集了进一步的证据表明临床，观察者和患者报告的COA的心理测量特性。通过多样性和全面的外部技术咨询委员会的投入，这些目标的完成将有助于支持以患者为中心的急性疼痛药物试验并减轻小儿药物开发中投资的燃烧。