Strategies to enhance pediatric clinical trial participation: A systematic review with narrative synthesis.

Abstract

BACKGROUND/OBJECTIVES\nRecruitment has been identified as a key barrier to conducting pediatric trials. However, no current guidelines have been used for evidence-based strategies to optimize the recruitment of children. In this review, we identify and codify strategies to enhance pediatric clinical trial participation in the current literature for future study in implementation trials.\n\n\nMETHODS\nSearches were conducted in MEDLINE/PubMed, EMBASE, and Web of Science. Studies were included if they focused on improving recruitment of children <18\xa0years of age into clinical trials and were published prior to December 1, 2020. Data extracted included information on study design, recruitment population, key recruitment strategy recommendations, and motivators and barriers of trial participation.\n\n\nRESULTS\nOut of the 80 included studies, strategies proposed to increase pediatric clinical trial participation were extremely varied in terms of strategy type and level of evidence. None of these studies were pediatric dermatology specific. We categorized strategies into the following groups: protocol development/pre-trial planning, trial marketing, educational tools, communication strategies, community involvement, incentives, or structural changes.\n\n\nCONCLUSIONS\nWe identified and codified strategies reported in the literature for increasing pediatric recruitment and found that few are evidence-based. Investigators should consider incorporating strategies to enhance recruitment in each stage of clinical trial conduct and tailor recruitment techniques to the specific population of interest. While some strategies should be employed broadly, others could benefit from further study in implementation trials to determine their comparative effectiveness in recruiting different groups of children.