Recruiting ENT and Audiology patients into pharmaceutical trials: evaluating the multi-centre experience in the UK and USA

<i>Objective</i>: Recruiting into clinical trials on time and on target is a major challenge and yet often goes unreported. This study evaluated the adjustment to procedures, recruitment and screening methods in two multi-centre pharmaceutical randomised controlled trials (RCTs) for hearing-related problems in adults. <i>Design</i>: Recruitment monitoring and subsequent adjustment of various study procedures (e.g. eligibility criteria, increasing recruiting sites and recruitment methods) are reported. Participants were recruited through eight overarching methods: trial registration, posters/flyers, print publications, Internet, social media, radio, databases and referrals. The efficiency of the recruitment was measured by determining the number of people: (1) eligible for screening as a percentage of those who underwent telephone pre-screening and (2) randomised as a percentage of those screened. <i>Study sample</i>: A total of 584 participants completed the pre-screening steps, 491 screened and 169 participants were randomised. <i>Results</i>: Both RCTs completed adjustments to the participant eligibility, added new study sites and additional recruitment methods. No single recruitment method was efficient enough to serve as the only route to enrolment. <i>Conclusion</i>: A diverse portfolio of methods, continuous monitoring, mitigation strategy and adequate resourcing were essential for achieving our recruitment goals.

<i>研究目标</i>: 按时按既定目标完成临床试验招募是一项重大挑战，却往往未被充分报道。本研究针对两项针对成人听力相关问题的多中心制药类随机对照试验（randomised controlled trials, RCTs），评估了其研究流程、招募及筛查方法的调整情况。<i>研究设计</i>: 本研究对各项研究流程（如入排标准、增加招募中心及招募手段）的招募监测与后续调整情况进行了报道。受试者通过八大类主要途径招募：试验注册、海报/传单、印刷出版物、互联网、社交媒体、广播、数据库及转诊。招募效率通过两项指标衡量：(1) 符合筛查条件者占电话预筛查人群的百分比；(2) 随机分组者占筛查人群的百分比。<i>研究样本</i>: 总计584名受试者完成预筛查流程，491名接受筛查，其中169名完成随机分组。<i>研究结果</i>: 两项随机对照试验均完成了受试者入排标准调整，新增了研究中心及额外招募手段。未存在任何单一高效的招募方法可作为唯一入组途径。<i>研究结论</i>: 多元化的招募手段组合、持续监测、应对策略及充足的资源配置，是达成招募目标的核心要素。