Background older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients. Objective to identify key barriers and to discuss solutions to specific issues affecting recruitment and retention of older participants in clinical trials based on experience gained from six current European randomised controlled trials (RCTs) focusing on older people. Methods a multidisciplinary group of experts including representatives of the six RCTs held two networking conferences and compiled lists of potential barriers and solutions. Every item was subsequently allocated points by each study team according to how important it was perceived to be for their RCTs. Results the six RCTs enrolled 7,612 older patients. Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural systems. All trials had to increase the number of recruitment sites. Other measures felt to be effective included the provision of extra time, communication training for the study staff and a re-design of patient information. Key barriers for retention included the presence of severe comorbidities and the occurrence of adverse events. Long study duration, frequent study visits and difficulties accessing the study site were also mentioned. Solutions felt to be effective included spending more time maintaining close contact with the participants, appropriate measures to show appreciation and reimbursement of travel arrangements. Conclusion recruitment and retention of older patients in trials requires special recognition and a targeted approach. Our results provide scientifically-based practical recommendations for optimizing future studies in this population.

中文翻译：

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在临床试验中招募和保留老年患者的障碍和潜在解决方案——从六项大型多中心随机对照试验中吸取的教训

背景 老年人在临床试验中的代表性仍然不足，在年轻人群中产生的证据并不总是适用于老年患者。目的是根据从目前针对老年人的六项欧洲随机对照试验 (RCT) 中获得的经验，确定关键障碍并讨论影响临床试验招募和保留老年参与者的具体问题的解决方案。方法 包括六个 RCT 代表在内的多学科专家组举行了两次网络会议，并编制了潜在障碍和解决方案清单。随后，每个研究团队根据对 RCT 的重要性对每个项目进行评分。结果 六项随机对照试验招募了 7,612 名老年患者。招募的主要障碍是健康状况受损，合并症和不同的健康信念，包括不同文化系统中的优先事项。所有试验都必须增加招募站点的数量。其他被认为有效的措施包括提供额外的时间、对研究人员进行沟通培训以及重新设计患者信息。保留的主要障碍包括严重合并症的存在和不良事件的发生。研究持续时间长、研究访问频繁和访问研究地点的困难也被提及。被认为有效的解决方案包括花更多时间与参与者保持密切联系，采取适当措施表示赞赏和报销旅行安排。结论 在试验中招募和保留老年患者需要特殊的认可和有针对性的方法。