[关键词]
[摘要]
药物临床试验是评估新药安全性、有效性,推动医学进步,提供创新治疗方法不可或缺的关键步骤;在中国老龄化人口增加的趋势下,提升临床试验老年受试者的依从性至关重要。为确保研究结果更具代表性和适用性,建议采取以下措施:首先,制定个性化支持计划和多元化的依从性监测方法;其次,根据老年人的生活方式和需求,调整试验设计以提升参与的舒适度和便捷性;此外,建立社会支持系统以提供更广泛的支持;最后,通过加强研究团队的培训,提高对老年患者的关怀水平,激发其积极性和合作度。这些举措有助于减小药物临床试验的选择性和信息偏倚,为改善医疗护理和推动医学科学的发展提供可靠的研究基础。通过科学、伦理和规范的试验设计和实施,可以更好地评估药物的效果,为患者提供更好的医疗选择。
[Key word]
[Abstract]
Clinical drug trials are crucial steps in assessing the safety and efficacy of new medications, driving medical advancements, and providing essential innovation in treatment methods. With the increasing trend of aging populations in China, enhancing the compliance of elderly participants in clinical trials is of paramount importance. To ensure more representative and applicable research outcomes, the following measures are recommended:firstly, establish personalized support plans and diverse compliance monitoring methods. Secondly, adjust trial designs based on the lifestyles and needs of older individuals to enhance participation comfort and convenience. Furthermore, establish social support systems to provide broader assistance. Finally, strengthen the training of research teams to elevate the level of care for elderly patients and stimulate their enthusiasm and cooperation. These initiatives contribute to reducing selection and information biases, laying a reliable research foundation for improving healthcare and driving advancements in medical science. Through scientifically, ethically, and rigorously designed and implemented trials, a better assessment of the effectiveness of medications can be achieved, offering improved medical choices for patients.
[中图分类号]
R969.4
[基金项目]
上海市中医药“三年行动计划”项目[ZY(2021-2023)-0211];上海市“科技创新行动计划”生物医药科技支撑专项(20S21902100);上海市教委协同创新中心:中西医结合-中成药临床评价平台项目(A1-U21-205-0103);上海市慢性筋骨病临床医学研究中心项目(20MC1920600);上海市科委2022年度第三批应急科技攻关项目(22YJ1900505);上海市申康中心示范性研究型病房建设项目(SHDC2022CRW010);上海市申康中心医企融合创新协同专项(SHDC2022CRT018)