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Medicineworld.org: Older adults often excluded from clinical trials

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Older adults often excluded from clinical trials




Older individuals, who constitute a rapidly growing population in the United States, account for a disproportionate share of health care utilization and cost.

Yet more than half of clinical trials exclude people based on their age or age-related conditions, as per a newly released study by Robert Wood Johnson Foundation (RWJF) Clinical Scholars� at the University of Michigan.

"These findings are concerning because it means that doctors cannot be confident that clinical trial results apply to their older patients," says Donna Zulman, M.D., the study's main author and a Veterans Affairs scholar with the RWJF Clinical Scholars program at the University of Michigan Health System. "Health care providers and patients need better evidence about therapy strategies that improve the health and quality of life of seniors".



Older adults often excluded from clinical trials

As of 2009, Americans over the age of 65 represented 12.5 percent of the U.S. population�about one in every eight Americans�and by 2030, that number is expected to almost double.

This population accounts for 34 percent of personal health care expenditures, with the majority of spending attributed to individuals with chronic diseases.

Yet in a review of clinical trials published in major medical journals, Zulman and her colleagues observed that one in five trials excluded patients based on their age alone. Furthermore, almost half of the remaining trials excluded individuals using criteria that could disproportionately impact elderly adults, such as physical frailty or impaired cognition.

The study also observed that trials rarely assess how therapys affect function and quality of life, outcomes that are often of great importance to older individuals.

"These practices leave health care providers in the dark when determining which therapy will best serve the needs of their patients," says Zulman.

"It is rarely appropriate to exclude people from clinical trials based on their age alone," argues Jeremy B. Sussman, M.D., a co-author of study and a Veterans Affairs scholar with the RWJF Clinical Scholars program at the U-M. "This is particularly true in trials investigating conditions that are common in elderly adults."

The study authors suggest that clinical trial evidence guiding therapy of elderly adults would be improved by eliminating upper age limits for study inclusion, by reducing the use of eligibility criteria that disproportionately affect older patients, and by encouraging adherence to recommended analytical methods for evaluating therapy effects by age.

"There's a critical need to ensure that research findings are relevant for our most complex and vulnerable older patients," says Zulman. "Our findings suggest a need for policy change by government agencies like the Food and Drug Administration and the National Institutes of Health to increase the representation of typical elderly adults in clinical trials."


Posted by: Janet    Source




Did you know?
Older individuals, who constitute a rapidly growing population in the United States, account for a disproportionate share of health care utilization and cost. Yet more than half of clinical trials exclude people based on their age or age-related conditions, as per a newly released study by Robert Wood Johnson Foundation (RWJF) Clinical Scholars� at the University of Michigan.

Medicineworld.org: Older adults often excluded from clinical trials

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