Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany.
Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Trials. 2021 Mar 1;22(1):178. doi: 10.1186/s13063-021-05119-6.
Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes).
Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed.
In total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%).
The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations.
EudraCT 2014-003080-38 . Registered on 14 July 2014.
临床试验中招募参与者的数量较少是一个常见且代价高昂的问题，它会破坏医学研究。本研究旨在调查在招募患有强迫症和自闭症谱系障碍的儿童和青少年参与一项随机、双盲、安慰剂对照临床试验时所面临的挑战，并分析未参与的原因。该试验是欧盟 FP7 项目 TACTICS（强迫综合征的青少年和儿童治疗干预转化研究）的一部分。
系统收集了预筛选患者的人口统计学数据，包括记录未参与的原因。将发现结果按照内容分组，并对数据进行描述性统计分析。
共有 173 名患者接受了潜在参与临床试验的预筛选。其中，只有 5 名（2.9%）最终入组。未纳入的主要原因如下：未满足所有纳入标准/符合一个或多个排除标准（n=73；42.2%）、对试验或一般试验不感兴趣（n=40；23.1%）、不希望改变当前治疗/药物（n=14；8.1%）。
本研究的结果为儿科精神科人群临床试验招募率低的原因提供了有价值的信息。低入组率和高排除率引发了一个问题，即这种选择性研究人群是否能代表临床患者群体。因此，此类试验的结果可能具有一定的局限性。本研究的结果将有助于制定改进的招募策略，并指导未来的研究，以建立代表性的衡量标准，确保在儿科人群的精神药理学临床试验中提高外部有效性。
EudraCT 2014-003080-38，于 2014 年 7 月 14 日注册。
