Clinical Trials Fail to Sufficiently Represent Older Adults | Aging In Action

by John Davy

Older adults use the highest proportion of medical and pharmaceutical treatment, but are vastly underrepresented in clinical trial research. A recent review of publications based on randomized control trials (Zulman et al 2011) shows that this is not only a product of the under-recruitment of older adults. In addition to the use of age limits and other exclusion criteria that tend to preclude older individuals, most clinical research fails to look at outcomes of particular relevance to older adults. Further, many published studies employ statistical methods that may misrepresent the significance of age in their findings.

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Age Discrimination in Clinical Research: Time For Action | GeriPal - Geriatrics and Palliative Care Blog

Image via WikipediaOlder persons are often severely underrepresented in clinical trials of new drugs, therapies, and devices. Usually, their exclusion from these studies can not be scientifically justified. Some studies actually have age cutoffs, but more often the exclusion of older persons is more indirect. For example, most older persons have more than one disease. A study of a treatment for disease X may exclude a person who also happens to have disease Y, even though persons with disease Y will be part of the target population for therapy once the treatment is approved. Sometimes, the exclusion of the elderly is even more subtle---such as excluding subjects who need transportation assistance to get to the study center.

The exclusion of older persons from clinical studies, whether through direct exclusion of older persons, or indirect exclusions based on factors such as comorbidity or functional impairment is rarely justificable. If an elder would be a realistic candidate for the therapy being studied, there is no valid reason for their exclusion.

The absence of older persons from clinical studies has adversely impacted our ability to care for them. For a multitude of problems common in older persons, the best approach to care is not clear because we have minimal research which informs what works and what does not work in older persons.

These concerns are discussed in an excellent article in the Journal of American Geriatrics Society titled, "Fighting Age Discrimination in Clinical Trials." The article examines many of the barriers that have inhibited enrollment of older persons in clinical research and proposes solutions. It calls for steps to end age discrimination in clinical trials.

Age Discrimination in Clinical Research: Time For Action | GeriPal - Geriatrics and Palliative Care Blog

What to Tell Alzheimer’s Patients After a Trial Goes Awry - NYTimes.com

Image via CrunchBaseby Gina Kolata

Dr. Joel Ross, the founder and chief executive of the Memory Enhancement Centers of New Jersey, makes his living enrolling subjects in drug company clinical trials that are testing drugs for Alzheimer’s disease, among others.

So when Eli Lilly announced last week that its promising Alzheimer’s drug was making patients worse and that it was halting two large clinical trials, it seemed likely that Dr. Ross would hear from family members of his patients. Are other experimental Alzheimer’s drugs safe? they might ask. Should they get their family members out of those Alzheimer’s studies?

Not a single family member called. And Dr. Ross is not sure why.

If a study of an experimental breast cancer drug was ended because it made the cancer grow and spread, women in other breast cancer studies of similar drugs would be calling their doctors and asking what to do.

But Alzheimer’s is different. “It may reflect the incredible desperation surrounding Alzheimer’s disease,” said Baruch Brody, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
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