Center for Clinical Trials, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Chair of Clinical Pharmacology, Department of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
Syst Rev. 2024 Nov 20;13(1):283. doi: 10.1186/s13643-024-02698-8.
Recruiting a sufficient number of patients is often a challenge for conducting clinical trials. Published data reveal that only 10% of eligible patients according to inclusion and exclusion criteria are enrolled in clinical trials. Consequentially, identifying barriers and facilitators may improve enrollment. These factors may differ in the pediatric population, for example, due to the involvement of parents in the decision-making process. We aimed to conduct an overview of systematic reviews to summarize the barriers and facilitators influencing the enrollment of pediatric participants in clinical trials.
A systematic literature search in PubMed and Epistemonikos of published systematic reviews focusing on barriers and facilitators influencing the enrollment of pediatric patients in clinical trials was conducted. Study selection, data extraction, and quality assessment were performed by two authors independently. The methodological quality was judged using a critical appraisal tool. Finally, data were narratively synthesized.
Of 283 identified systematic reviews, four met the inclusion criteria and were included in the overview. Parents belonging to an ethnic minority or having low socioeconomic status were identified as barriers to enrollment whereas higher parental education and higher age served as facilitators. Additionally, existing expectations, previous treatment experiences and preferences, study duration, type of control group, and the child's attitude toward study participation could favor or hinder participation. Furthermore, physicians' opinions of study-related treatments may also influence the enrollment process.
This overview provides a summary of barriers and facilitators to the enrollment of pediatric patients in clinical trials. Taking into account this information may enhance the enrollment of this hard-to-reach population.
招募足够数量的患者通常是进行临床试验的一个挑战。已发表的数据显示，只有符合纳入和排除标准的 10%的合格患者被纳入临床试验。因此，确定障碍和促进因素可能会提高入组率。这些因素在儿科人群中可能有所不同，例如，由于父母参与决策过程。我们旨在进行系统评价综述，以总结影响儿科参与者参与临床试验的障碍和促进因素。
在 PubMed 和 Epistemonikos 中进行了一项针对影响儿科患者参与临床试验的纳入和排除标准的系统文献检索，以发表的系统评价为重点。两名作者独立进行了研究选择、数据提取和质量评估。使用批判性评估工具判断方法学质量。最后，对数据进行叙述性综合。
在 283 项已确定的系统评价中，有 4 项符合纳入标准并被纳入综述。属于少数民族或社会经济地位较低的父母被认为是入组的障碍，而较高的父母教育程度和较高的年龄则是促进因素。此外，现有期望、以前的治疗经验和偏好、研究持续时间、对照组类型以及孩子对参与研究的态度都可能有利于或阻碍参与。此外，医生对与研究相关的治疗的看法也可能影响入组过程。
该综述总结了儿科患者参与临床试验的障碍和促进因素。考虑到这些信息可能会提高这一难以接触到的人群的入组率。
