Study says older adults vastly underrepresented in COVID-19 trials

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic leader on aging. Her work has appeared in, Journal of Active Aging, Cancer Today, Kaiser Health News and other outlets. She is a senior fellow at the Center for Health Policy and Media Engagement at George Washington University and co-produces the HealthCetera podcast.

Elderly couple wearing masks

Photo: Babette Plana via Flickr

Approximately 80% of COVID-19 related deaths in the United States have been among people 65 or older, according to the Centers for Disease Control and Prevention. But a research letter published online in JAMA Internal Medicine on Sept. 28 reported that more than half of COVID-19 clinical trials were “at high risk for excluding older adults,” and none included seniors as part of vaccine trials early in the pandemic.

Despite a National Institute of Health policy mandating the inclusion of older adults in appropriate clinical trials, older adults were left out more often than not as scientists struggled to get a handle on the coronavirus. Researchers found that 53% of trials they reviewed did not include those older than 65 for a variety of reasons, including compliance concerns, co-morbid conditions or technology requirements. About one in four of the trials reviewed by the researchers included an age “cutoff” that would exclude adults age 65 to 80, as UPI reported.

Researchers analyzed all active or planned clinical trials, indexed in between Oct. 1, 2019 and June 1, 2020, that had been specifically intended for prevention or treatment of COVID-19. Because of the expedited nature of most current trials and the multiple phases included in many indexed trials, they opted to review all trials in all phases simultaneously.

Out of an eventual 847 clinical trials meeting review criteria, the study found that in 232 phase 3 trials, 38 (16%) included age cutoffs and 77 (33%) had exclusions preferentially affecting older adults. The analysis determined 115 (50%) trials were considered high risk for excluding older adults. Of 18 vaccine trials, 11 (61%) included age cutoffs and the remaining 7 had broad non-specified exclusions. Thus, 100% were considered high risk for excluding older adults, they found.

“Such exclusion will limit the ability to evaluate the efficacy, dosage, and adverse effects of the intended treatments,” the research letter said. “We acknowledge that some exclusions for severe or uncontrolled comorbidities will be essential to protect the health and safety of older adults. However, caution must be taken to avoid excluding otherwise eligible participants for reasons that are not well-justified.”

The research team did acknowledge that they did not conduct a detailed review of every study protocol and so could not thoroughly analyze the appropriateness of certain comorbidity exclusions.

Antibody response decreases with age, so dosage and frequency of potential vaccines may be vastly different than for younger adults or children, the authors noted. Including this cohort in any trials was imperative, they said and questioned whether physicians and older adults might balk at treatments or vaccines that lacked more data on efficacy, titration, and side effects among this cohort.

Journalists may want to speak with physicians, nurses and other health professionals about whether they would feel comfortable giving a treatment or vaccine to an older adult if data on this demographic was limited or non-existent. How do older people feel about taking a vaccine whose efficacy and regimen may not be clear for their age group?

2 thoughts on “Study says older adults vastly underrepresented in COVID-19 trials

  1. Eileen Beal

    A very major problem, with (sigh) no real solution is the fact that older adults don’t get into trials because they can’t GET to them…and I’m not just talking about mobility limitations. A vast percentage — perhaps a majority?–of older adults are rural or ex-urban residents, while the vast majority of trials take place in urban areas. In addition, there are cognitive issues that are insurmountable and “secondary” subjects (family caregivers) who must be included in all the above if the older person is to be a trial participant.
    SO, to ding researchers for not including older adults is simply — to mix my metaphors — beating an already burdened dog.
    A better response to this problem/challenge would be to provide context for what’s going on…and that begins with covering the MANY and GORDIAN KNOT COMPLEX REASONS that older adult are not included in trials.
    E. Beal, Asso Member

  2. Ruth Taber

    No surprise – years of drug testing – never including anyone over 65 – and this is more of the same. Add to this the shortage of physicians choosing geriatrics as a specialty (lowest pay, most time consuming) and another “no surprise” when we see elders with longs lists of drugs in their shopping carts – and many of these Rx’s interact (often poorly or harmfully) with each other, This happens when elders visit internists who don’t have a clue about treating the old,old patient and prescribe with knowledge based on visiting drug reps.
    These days the reps don’t show up as much – but the prescribing patterns are built in.

Leave a Reply