Designing clinical trials in older people.

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.