Functional outcomes for clinical trials in frail older persons: time to be moving.

摘要

ON January 10 and 11, 2007, a working group (*see Appendix for listing of group members) met in Bethesda, Maryland, to discuss the subject of appropriate outcomes for trials designed to improve functional status in elderly people. In addition to the working group, representatives from the Food and Drag Administration (FDA) and the National Institute on Aging (NIA) participated in this meeting. The purpose of this special article is to describe the issues related to design and implementation of clinical trials with the intent of improving functional status of older people, with the ultimate outcome the approval of a specific drag by the FDA or widespread use of lifestyle interventions to delay or prevent functional declines associated with aging.