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提高老年人参与疫苗临床试验的程度:挑战与策略。

Enhancing vaccine clinical trials participation among elderly: challenges and strategies.

作者信息

Gillard Paul, Nakhle Samer, Brimhall Darin, Henry Ouzama, Mesaros Narcisa

机构信息

PPD Clinical Research Business of Thermo Fisher Scientific, Sint-Stevens-Woluwe, 1932, Belgium.

Palm Medical Group, Las Vegas, Nevada, USA.

出版信息

Trials. 2025 Feb 3;26(1):38. doi: 10.1186/s13063-025-08754-5.

Abstract

As the fastest growing demographic worldwide, the elderly population is projected to reach nearly 1 billion by 2030 and double the 2022 number by 2050. Despite being the largest consumers of medications, they have been historically underrepresented in clinical trials. However, we are witnessing a promising shift as their participation in trials is on the rise. In fact, recent megatrials enrolling more than 30,000 elderly participants demonstrated the feasibility of large-scale clinical trials involving this very specific population. However, unique challenges, including multi-morbidities, frailty, and ethically sound informed consent in those with cognitive deficits, require continuous careful reassessments and flexibility. Creative and tailored strategies are of paramount importance to bolster elderly trial participation. This paper highlights challenges and shares our experiences on novel methods and success stories associated with the enrollment and retention of elderly individuals in clinical trials. Successful tactics to balance the burden of clinical trial participation with its benefits encompass regular contact, family and friends' engagement, making travel easier or unnecessary, use of digital tools, and building relationships with community organizations. Through innovative strategies that consider the unique needs and limitations of this population, we can achieve successful participation in clinical trials. This will lead to more effective treatments and interventions for our growing elderly population.

摘要

作为全球增长最快的人口群体,预计到2030年老年人口将接近10亿,到2050年将是2022年数量的两倍。尽管老年人是药物的最大消费群体,但他们在临床试验中的代表性历来不足。然而,随着他们参与试验的人数不断增加,我们正在目睹一个充满希望的转变。事实上,最近招募了超过30000名老年参与者的大型试验证明了涉及这一非常特殊人群的大规模临床试验的可行性。然而,包括多种疾病、身体虚弱以及认知缺陷者的符合伦理的知情同意等独特挑战,需要持续仔细的重新评估和灵活性。创新和量身定制的策略对于促进老年人参与试验至关重要。本文重点介绍了挑战,并分享了我们在老年人参与和留在临床试验方面的新方法及成功案例的经验。平衡临床试验参与负担与其益处的成功策略包括定期联系、让家人和朋友参与、使出行更便捷或无需出行、使用数字工具以及与社区组织建立关系。通过考虑这一人群独特需求和局限性的创新策略,我们能够实现老年人成功参与临床试验。这将为不断增加的老年人口带来更有效的治疗和干预措施。

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