Parks Ruth M, Holmes Holly M, Cheung Kwok-Leung
Nottingham Breast Cancer Research Centre, School of Medicine, University of Nottingham, Nottingham, UK.
Division of Geriatric and Palliative Medicine, University of Texas Health Science Center McGovern Medical School, Houston, USA.
Oncol Ther. 2021 Jun;9(1):55-67. doi: 10.1007/s40487-021-00140-w. Epub 2021 Jan 22.
The number of older adults living with cancer is increasing. There is a clear lack of representation of older adults in clinical trials, including cancer trials. Reasons for this are multifactorial and complex and include protocol, patient and sponsor factors. Potential solutions to overcome issues with trial design include varied methods of recruitment with flexible inclusion criteria. Possible alternatives to randomised trials include prospective cohort studies, pragmatic trials and the use of national population-based data sets. Patient factors may be addressed by integration of geriatric assessment, so patients can be randomised or treated based on their individual needs. Additionally, standard protocols for including older adults with cognitive impairment should be developed, rather than automatic exclusion. Increased effort is needed from sponsors and governing health care bodies to make recruitment of older adults to clinical trials standard.
患癌症的老年人数量正在增加。在包括癌症试验在内的临床试验中，老年人的代表性明显不足。造成这种情况的原因是多方面且复杂的，包括方案、患者和申办方因素。克服试验设计问题的潜在解决方案包括采用多种招募方法和灵活的纳入标准。随机试验的可能替代方案包括前瞻性队列研究、实用试验以及使用基于全国人口的数据集。可以通过整合老年评估来解决患者因素，这样患者就可以根据个人需求进行随机分组或治疗。此外，应该制定纳入有认知障碍老年人的标准方案，而不是自动排除。申办方和管理医疗保健机构需要付出更多努力，使招募老年人参与临床试验成为标准做法。
