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老年人群参与临床试验:障碍与解决方案。

Participation of the elderly population in clinical trials: barriers and solutions.

作者信息

Denson Aaron C, Mahipal Amit

机构信息

Clinical Research Unit, Moffitt Cancer Center, Tampa, FL 33612, USA.

出版信息

Cancer Control. 2014 Jul;21(3):209-14. doi: 10.1177/107327481402100305.

Abstract

BACKGROUND

Despite the fact that cancer disproportionately affects the elderly, most participants of clinical cancer trials are relatively young. This misrepresentation greatly affects the oncology treatment of the elderly population (> 65 years of age). Few studies have attempted to identify the problems related to discrepancy based on age for clinical trial participation.

METHODS

A literature review was performed to identify barriers and solutions to enrollment of elderly persons for clinical cancer trials.

RESULTS

Physician-related barriers include perception about treatment tolerance, drug metabolism, a lack of evidence for efficacy, and age bias. Lack of autonomy, concerns about quality of life and toxicities, accessibility to clinical trials, and logistical and financial difficulties are common patient-related barriers. Trial-related barriers include eligibility criteria based on performance status, organ dysfunction, and the presence of comorbidities. Solutions, such as improved communication, and coordinating logistical challenges may help overcome some of these challenges. Studies designed for the geriatric population could modify the perception and behavior of health care professionals and improve patient participation in clinical trials.

CONCLUSIONS

Implementing some of these solutions and increased research may help overcome shortfalls in elderly enrollment, thus allowing for more effective treatment of older patients.

摘要

背景

尽管癌症对老年人的影响尤为严重,但大多数临床癌症试验的参与者相对年轻。这种代表性不足极大地影响了老年人群(65岁以上)的肿瘤治疗。很少有研究试图确定基于年龄差异的临床试验参与相关问题。

方法

进行文献综述以确定老年人群参与临床癌症试验的障碍和解决方案。

结果

与医生相关的障碍包括对治疗耐受性、药物代谢、疗效缺乏证据以及年龄偏见的认知。缺乏自主性、对生活质量和毒性的担忧、临床试验的可及性以及后勤和经济困难是常见的与患者相关的障碍。与试验相关的障碍包括基于体能状态、器官功能障碍和合并症的纳入标准。诸如改善沟通以及协调后勤挑战等解决方案可能有助于克服其中一些挑战。针对老年人群设计的研究可以改变医疗保健专业人员的认知和行为,并提高患者对临床试验的参与度。

结论

实施其中一些解决方案并增加研究可能有助于克服老年人群入组不足的问题,从而使老年患者得到更有效的治疗。

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