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 父母奖的总体目标是用激光多普勒（HILD）验证组胺离子噬菌体 哮喘儿童中对左旋甲虫的治疗反应预测的流动生物标志物。这 研究补充剂将支持父母奖的两个目标作为父母奖基本研究 活动包括在儿童中进行大型临床试验。完成安全有效的临床试验 儿童对于小儿药物开发至关重要。超过20％的小儿临床试验失败或中断 由于缺乏入学人数和30％以上的试验，早期无法达到最初定义的招聘目标。障碍 必须检查并解决儿科临床试验中的参与者招募和保留率，以增加 成功试验的数量以及重要的儿科剂量，安全性和功效的传播 信息。总体而言，缺乏针对小儿试验招募和保留的循证策略。 我们将利用实际的儿科临床试验中的数据来解决这一差距。这种补充支持 通过解决三个关键领域的未来儿科临床试验的成功。我们将1）比较三个 招募和留住儿科临床试验参与者的策略； 2）确定是否有效 招聘和保留策略在黑人/非洲裔美国儿童和白人儿童之间有所不同；和 3）为Ikerionwu女士提供小儿临床试验的培训和基础知识， 支持她作为一名有抱负的医师研究员进行儿科临床试验的发展。这 本应用的目的是确定注册和最有效的方法 将儿童保留在双盲，安慰剂对照临床试验中。我们假设会有 为儿科参与者招募和保留而确定的出色策略。这将通过 目的I旨在确定小儿临床试验的最有效招聘策略。我们假设 通过面对面接触在临床中进行招聘的招聘有效性中存在差异 设置，基于患者名单的电视招聘以及社区伙伴关系策略以及该面对面的 临床环境中的招聘策略将提高效率和有效性。在AIM II中，我们 将确定在小儿临床试验中保留的障碍。在这两个目标中，我们还将确定 身份为白人/高加索人的儿童之间有效招募和保留策略的差异 与识别为黑人/非裔美国人的孩子相比。本申请中的拟议工作将 在小儿临床试验和临床研究中提供基本知识和技能 来自代表性不足的背景的初级调查员，因此导致了未来的医生职业 科学家。这项工作还将提供基于证据的知识，以告知成功的招聘和保留 在各种儿科临床试验中。