A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

指导小儿哮喘治疗的组胺药效生物标志物

• 批准号: 10705453
• 负责人: BRIDGETTE L. JONES
• 金额: $ 7.13万
• 依托单位: CHILDREN'S MERCY HOSP (KANSAS CITY, MO)
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705453
• 关键词: Address; African American; Antihistamines; Area; Asthma; Award; Black race; Caucasians; Child; Childhood; Childhood Asthma; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials; Conduct Clinical Trials; Controlled Clinical Trials; Cross-Sectional Studies; Data; Development; Dose; Double-Blind Method; Effectiveness; Enrollment; Extrinsic asthma; Family; Frequencies; Future; Glean; Goals; Health; Histamine; Intervention; Iontophoresis; Knowledge; Lasers; Methods; Monitor; Outcome; Parents; Participant; Patient Recruitments; Patients; Pediatric Research; Pharmaceutical Preparations; Physicians; Placebo Control; Population Heterogeneity; Race; Reporting; Research; Research Activity; Research Design; Research Personnel; Safety; Scientist; Therapeutic; Therapeutic Clinical Trial; Therapeutic Uses; Time; Training; Underrepresented Populations; Work; career; clinical trial recruitment; cohort; community partnership; comparative efficacy; design; discontinuation trial; double-blind placebo controlled trial; efficacy clinical trial; evidence base; improved; parent grant; participant enrollment; participant retention; pediatric drug development; pharmacodynamic biomarker; predictive marker; recruit; retention rate; skills; success; therapeutically effective; treatment response; trial design

Project Summary The overarching goal of the parent award is to validate the Histamine Iontophoresis with Laser Doppler (HILD) flowimetry biomarker for prediction of treatment response to Levocetirizine among children with asthma. This research supplement will support both aims of the parent award as the parent award primary research activities include the conduct of a large clinical trial in children. Completion of safe and efficient clinical trials in children is essential for pediatric drug development. Over 20% of pediatric clinical trials fail or are discontinued early due to lack of enrollment and over 30% of trials do not meet initially defined recruitment goals. Barriers to participant recruitment and retention within pediatric clinical trials must be examined and addressed to increase the number of successful trials and the dissemination of important pediatric dosing, safety, and efficacy information. Overall, there is a lack of evidence-based strategies for pediatric trial recruitment and retention. We will address this gap, utilizing data from a real-world pediatric clinical trial. This supplement supports the success of future pediatric clinical trials by addressing three key areas. We will 1) compare the efficacy of three strategies for recruiting and retaining participants in pediatric clinical trials; 2) determine whether the efficacy of recruitment and retention strategies differs between Black/ African American children and White children; and 3) provide Ms. Ikerionwu with training and foundational knowledge in the conduct of pediatric clinical trials that supports her development as an aspiring physician-researcher conducting pediatric clinical trials. The objective of this application is to determine the most effective and efficient methods for enrolling and retaining children in a double blinded, placebo controlled clinical trial. We hypothesize that there will be superior strategies identified for pediatric participant recruitment and retention. This will be accomplished by Aim I to determine the most effective recruitment strategies for pediatric clinical trials. We hypothesize that differences exist in recruitment effectiveness between enrollment by face-to-face contact in clinical settings, tele-recruitment based on patients lists, and community partnership strategies and that face-to-face recruitment strategies within the clinical settings will have increased efficiency and effectiveness. In Aim II, we will determine barriers to retention in pediatric clinical trials. In both aims we will also determine differences in effective recruitment and retention strategies between children who identify as White/ Caucasian in comparison to children who identify as Black/ African American. The proposed work in this application will provide foundational knowledge and skills in the conduct of pediatric clinical trials and clinical research by a junior investigator from an under-represented background, thus leading to a future career as a physician scientist. The work will also provide evidenced based knowledge to inform successful recruitment and retention in diverse pediatric clinical trials.

项目摘要 家长奖的首要目标是用激光多普勒(HILD)验证组胺离子导入 流量计生物标志物用于预测哮喘儿童对左西替利嗪的治疗反应。这 研究补充将支持父母奖的两个目标，作为父母奖的主要研究 活动包括在儿童身上进行一项大型临床试验。年完成安全有效的临床试验 儿童对儿科药物开发至关重要。超过20%的儿科临床试验失败或终止 由于缺乏招生和30%以上的试验没有达到最初确定的招聘目标，这是一项较早的工作。障碍： 必须检查和解决儿科临床试验中参与者的招募和保留问题，以增加 成功试验的数量和重要儿科用药的传播、安全性和有效性 信息。总体而言，儿科试验招募和保留缺乏循证战略。 我们将利用来自真实世界的儿科临床试验的数据来解决这一差距。本补充资料支持 通过解决三个关键领域，确保未来儿科临床试验的成功。我们将1)比较三种药物的疗效 在儿科临床试验中招募和留住参与者的策略；2)确定 黑人/非裔美国儿童和白人儿童的招募和保留策略不同；以及 3)向Ikerion wu女士提供关于开展儿科临床试验的培训和基础知识 支持她发展成为一名有抱负的医生兼研究人员，进行儿科临床试验。这个 此应用程序的目标是确定最有效和最高效的注册和 将儿童留在双盲、安慰剂对照的临床试验中。我们假设将会有 为招募和留住儿科参与者确定了优越的战略。这将通过以下方式实现 目的确定儿科临床试验最有效的招募策略。我们假设 临床面对面接触招生在招募效果上存在差异 环境、基于患者名单的远程招聘、社区伙伴关系战略和面对面 临床环境中的招聘战略将提高效率和效力。在AIM II中，我们 将确定在儿科临床试验中保留的障碍。在这两个目标中，我们还将决定 白人/高加索儿童在有效招募和保留策略上的差异 与认同为黑人/非裔美国人的儿童相比。本申请中提议的工作将 提供进行儿科临床试验和临床研究的基础知识和技能 初级调查员来自代表性不足的背景，因此未来的职业生涯是内科医生 科学家。这项工作还将提供有证据的知识，为成功招聘和留住提供信息 在不同的儿科临床试验中。