UPPER AGE LIMITS IN CLINICAL TRIALS: UNDER-REPRESENTATION OF THE ELDERLY POPULATION
A.A. Walter, J.T. Cramer
J Aging Res Clin Practice 2012;1(1):10-12
The number of research studies and clinical trials conducted on the elderly (65+ years) has been increasing. There are growing concerns regarding age cutoffs as inclusion criteria in these studies. How old is too old to be a participant in a research study? If a clinical trial is studying the elderly population, should qualified, healthy participants be excluded simply because they are too old? Several recent reports have suggested that there is a lack of justification for setting upper age limits. Issues addressed in this paper include: (a) gender disparity, (b) comparison of “young-old” versus “old-old” subjects, (c) the external validity of extrapolating young results to old individuals, (d) the internal validity of subject mortality, and (e) verification of chronological age. Therefore, the purpose of this paper is to review the available data on ageism and make recommendations to rigorously justify or eliminate upper age cutoffs for studies examining the elderly based on the US Department of Health and Human Services (DHHS) and the US Food and Drug Administration (FDA) with safety and risk assessment in mind.