Introduction: Based on a literature review, main ethical and methodological issues raised by the implementation of randomized clinical trials involving elderly patients are discussed.
Current knowledge and key points: Despite their rapidly growing number and the subsequent significant increase in consumption of health care services and its cost, elderly patients have seldom been involved in clinical trials.
Future prospects and projects: However, the need for accurate scientific information on which relevant therapeutic decisions regarding this vulnerable population may be based has introduced marked changes in attitudes towards either clinical trials conducted in the elderly or requirements of various licensing authorities in regard to assessment of new drugs in elderly patients. Although difficulties pertaining to controlled clinical trials involving elderly patients may hamper both planning and carrying out of studies, completion of such trials may be achieved.