A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma

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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.