Clinical trials in the elderly: ethical and methodological considerations.

Introduction. - Based on a literature review, main ethical and methodologic al issues raised by the implementation of randomized clinical trials involv ing elderly patients are discussed. Current knowledge and key points. - Despite their rapidly growing number an d the subsequent significant increase in consumption of health care service s and its cost, elderly patients have seldom been involved in clinical tria ls. Future prospects and projects. - However, the need for accurate scientific information on which relevant therapeutic decisions regarding this vulnerab le population may be based has introduced marked changes in attitudes towar ds either clinical trials conducted in the elderly or requirements of vario us licensing authorities in regard to assessment of new drugs in elderly pa tients. Although difficulties pertaining to controlled clinical trials invo lving elderly patients may hamper both planning and carrying out of studies completion of such trials may be achieved. (C) 2000 Editions scientifiques et medicales Elsevier SAS.