Peninsula College of Medicine and Dentistry, University of Plymouth, Dept. Clinical Neurobiology, John Bull Building, Tamar Science Park, Research Way, Plymouth, Devon, UK.
Maturitas. 2011 Apr;68(4):337-41. doi: 10.1016/j.maturitas.2011.02.002. Epub 2011 Mar 3.
Adequate medical care of the increasingly ageing population requires robust clinical trial data both to inform treatment decisions, and to understand the natural history of diseases which primarily affect the elderly. However, this information is widely lacking, which is likely to have significant clinical consequences. Under-representation of older people in clinical trials is well documented, the reasons including physicians' perception, protocol eligibility criteria, and functional status requirements. Many clinical trial designs remain conservative and there is no established standardised methodology for recruiting more elderly patients with co-morbidities and disability into clinical trials. Designing clinical trials in older people poses a unique set of challenges, particularly regarding recruitment, retention and data analysis. In this review we outline the difficulties encountered in conducting clinical trials in older patients and describe some of the initiatives that can be put in place to counteract them. It is only by addressing these challenges with careful and adequately resourced protocol design that clinical trials may successfully address the therapeutic questions raised by our ageing population.
为不断老龄化的人口提供充分的医疗护理，需要有强大的临床试验数据，以便为治疗决策提供信息，并了解主要影响老年人的疾病的自然病史。然而，这方面的信息广泛缺失，这可能会产生重大的临床后果。老年人在临床试验中的代表性不足已得到充分记录，其原因包括医生的看法、方案的资格标准和功能状态要求。许多临床试验设计仍然保守，没有既定的标准化方法来招募更多患有合并症和残疾的老年患者参加临床试验。在老年人中设计临床试验带来了一系列独特的挑战，特别是在招募、保留和数据分析方面。在这篇综述中，我们概述了在老年患者中进行临床试验时遇到的困难，并描述了一些可以采取的措施来应对这些困难。只有通过精心设计和充分资源支持的方案来应对这些挑战，临床试验才能成功解决我们老龄化人口提出的治疗问题。
