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The Journals of Gerontology Series A: Biological Sciences and Medical Sciences Advance Access originally published online on March 6, 2009
The Journals of Gerontology Series A: Biological Sciences and Medical Sciences 2009 64A(4):487-491; doi:10.1093/gerona/gln042
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© The Author 2009. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Indications, Labeling, and Outcomes Assessment for Drugs Aimed at Improving Functional Status in Older Persons: A Conversation Between Aging Researchers and FDA Regulators

Working Group on Functional Outcome Measures for Clinical Trials*

Address correspondence to William J. Evans, PhD, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Slot 806, 4301 W Markham, Little Rock, AR 72205. Email: evanswilliamj@uams.edu

Received: April 6, 2008; Accepted: October 6, 2008
The first 150 words of the full text of this article appear below.

FUNCTIONAL and mobility limitations increase with advancing aging. Many older people have difficulty in simple activities such as walking or standing from a chair, and cannot tolerate even light physical activity. The etiology of these functional limitations is complex and often ascribed to conditions that escape the traditional definition of disease, which is at the core of clinical medicine. Although our society urgently needs new treatments that can reduce the burden of physical decline among older persons, guidelines on how these treatments should be developed and tested are currently lacking in part because a consensus has not yet been achieved regarding the identifiable target diseases. The demographic imperative and resulting burgeoning in population morbidity can no longer be ignored and requires a substantial adaptation of the system of drug development. In simple words, although functional and mobility limitations are increasingly prevalent in older people, only a handful of clinical . . . [Full Text of this Article]


   FDA GUIDELINES FOR AN INDICATION
 
Involuntary Weight Loss, Malnutrition, and Anorexia
Frailty
Sarcopenia
Mobility Limitation Secondary to Muscle Weakness

   CONCLUSIONS
 

   APPENDIX
 

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