Clinical Trial Design—Industry Perspective

Abstract

It is now well recognized that the elderly, defined as individuals over 65 years of age, are growing in numbers and as a proportion of the total population. It is also recognized that this group disproportionately uses medicines. At the present time, for example, the elderly represent about 11% of the U.S. population and are estimated to consume 20–25% of all medications.’ Based on data from the U.S. Census Bureau,² it is predicted that by 2030 the elderly will increase to about 21% of the U.S. population and consume more than 40% of all drugs. Equally important, the percentage growth of the “old elderly,” those 75 and over, will be even greater.³ The high prevalence of disabilities in the very old increases the chances for therapeutic misadventures. Indeed, it is widely perceived that adverse drug reactions and drug interactions are more common in the elderly than in younger patients. A recent report of the Royal College of Physicians on Adverse Drug Reactions in the Elderly⁴ identified inappropriate practices by treating physicians as central to this problem. On the other hand, a review by Klein et al. ⁵ suggests that the incidence of adverse drung reactions may not be greater in elderly patients but the opportunity for such events certainly is. Despite the extensive use of drugs by the elderly, guidance to physicians relative to this population is not widely available; i.e., dosage and precautions specific to the elderly are not commonly found in drung package inserts, therapeutic texts, or