Although they are by no means protected against diseases or being treated for chronic conditions, the very young and the elderly are frequently excluded from clinical trials. Because of this systemic problem in medical research, doctors are often relying on trial and error methods to treat patients who may metabolize drugs differently or have a different recovery experience than those studied.
Including older adults in trials often means providing transportation or home visits if participants have difficulty finding reliable transportation. Because seniors frequently have several co-existing medical conditions, researchers have historically steered clear of the complications elderly participants may present. According to a recent report in the New York Times, more than half of clinical trials for heart disease medications had an upper age limit of 75 or 80 and yet about 40 per cent of people who are hospitalized as a result of a heart attack are over 75.
Similarly, many studies won’t enroll nursing home residents or participants who have more than one disability, with a limited life expectancy or a cognitive impairment. This cuts out a significant segment of the population who could most benefit from a clearer evaluation of treatments for a host of conditions common among older adults.
The good news is that the National Institutes of Health has issued new policy and guidelines for research it funds requiring applicants for grants to explain how they plan to include people of all ages or justify why particular groups may be left out of a study. While this action may not immediately inform the decisions of doctors or how certain procedures or treatments will be tolerated by elderly patients, it’s a step in the right direction. The Alliance for Aging Research is also pushing for changes that require trial applicants seeking approval from the Food and Drug Administration to include older adults in their studies.
In a rapidly aging population, the number of seniors with multiple diseases taking several different medications will continue to rise and research and training will need to step up quickly to meet the health needs of seniors.
To learn more about the new NIH policy and guidelines for including participants of all ages in research studies, set to take effect in January 2019, follow this link to the National Institutes of Health’s Office of Extramural Research.