Skip to main content

Age Discrimination in Clinical Research: Time For Action

Older 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.

It is time to move beyond moral persuasion, and to take regulatory action to end the harmful practice of age discrimination in clinical research. The National Institutes of Health (NIH) is best placed to take the lead on this initiative. The NIH could use mechanisms already in place that have reduced other types of discrimination in clinical research. And the great prestige and stature of the NIH would cause their action to have more widespread impact.

The NIH could use processes they already have in place that have been effective in remediating exclusions of women and minority subjects from clinical research. Currently, any clinical study proposed for funding to the NIH MUST describe plans for the inclusion of women and minority populations. As part of the grant evaluation process, reviewers are required to comment on whether these plans are adequate. A grant that fails to present a valid scientific rationale for the exclusion of women and minority populations gets penalized. Further, the NIH will withhold funding until the representation of women and minority populations is addressed.

It it time for the NIH to add inclusion of older populations to the mandatory review criteria. This would mean that all clinical research applications to the NIH would be required to describe plans for the inclusion of older persons, or provide a compelling scientific justification for their exclusion. Grant reviewers would be required to comment on elder inclusiveness. And NIH would withhold funding from clinical research that has inadequate plans for inclusion of older persons until the plans are remediated.

This step by the NIH is the right thing to do and would go a long way towards making clinical research more relevant to older persons.

by: Ken Covinsky


R. said…
This is a long-overdue issue especially since older populations are often more sensitive to medications & require a lower dose.

Can GeriPal set up a E-mail function so that readers can clink on a link & send their message to NIH? Doing that would send the message loud & clear to NIH.
John A. Lynch said…
The obvious reason, of course, is that older patients would experience more side effects and "compromise" study results. Fewer drugs might be approved with more documented side effects and complications, which is exactly what should happen.

Instead, drugs are approved without long-term effects considered that will produce more adverse effects in the real world.

And drugs that should be used with extreme caution will be over-prescribed by a medical profession woefully uninformed of older patients' greater susceptibility to adverse medication interactions.

But drug company profits are enhanced. isn't that what it's all about?

Popular posts from this blog

The Dangers of Fleet Enemas

The dangers of oral sodium phosphate preparations are fairly well known in the medical community. In 2006 the FDA issued it’s first warning that patients taking oral sodium phosphate preparations are at risk for potential for acute kidney injury. Two years later, over-the-counter preparations of these drugs were voluntarily withdrawn by the manufacturers.  Those agents still available by prescription were given black box warnings mainly due to acute phosphate nephropathy that can result in renal failure, especially in older adults. Despite all this talk of oral preparations, little was mentioned about a sodium phosphate preparation that is still available over-the-counter – the Fleet enema.

Why Oral Sodium Phosphate Preparations Are Dangerous 

Before we go into the risks of Fleet enemas, lets spend just a couple sentences on why oral sodium phosphate preparations carry significant risks. First, oral sodium phosphate preparations can cause significant fluid shifts within the colon …

Opening the Black Box of LTACs: Podcast with Anil Makam

What happens in Long Term Acute Care Hospitals, or LTACs (pronounced L-tacs)?  I've never been in one.  I've sent patients to them - usually patients with long ICU stays, chronically critically ill, with a gastric feeding tube and a trach for ventilator support.  For those patients, the goals (usually as articulated by the family) are based on a hope for recovery of function and a return home.

And yet we learn some surprising things from Anil Makam, Assistant Professor of Medicine at UCSF.  In his JAGS study of about 14,000 patients admitted to LTACHs, the average patient spent two thirds of his or her remaining life in an institutional settings (including hospitals, LTACs and skilled nursing facilities).  One third died in an LTAC, never returning home.

So you would think with this population of older people with serious illness and a shorter prognosis than many cancers, we would have robust geriatrics and palliative care in LTACs?  Right? Wrong.

3% were seen by a geriatrici…

Length of Stay in Nursing Homes at the End of Life

One out of every four of us will die while residing in a nursing home. For most of us, that stay in a nursing home will be brief, although this may depend upon social and demographic variables like our gender, net worth, and marital status. These are the conclusions of an important new study published in JAGS by Kelly and colleagues (many of whom are geripal contributors, including Alex Smith and Ken Covinsky).

The study authors used data from the Health and Retirement Study (HRS) to describe the lengths of stay of older adults who resided in nursing homes at the end of life. What they found was that out of the 8,433 study participants who died between 1992 and 2006, 27.3% of resided in a nursing home prior to their death. Most of these patients (70%) actually died in the nursing home without being transferred to another setting like a hospital.

 The length of stay data were striking:

the median length of stay in a nursing home before death was 5 months the average length of stay was l…