Above: Older adults are being sought as test subjects for COVID-19 clinical trials. Photo by RODNAE Productions from Pexels
The use of the words “recruit” and “seniors” in the same sentence recently caught my attention. It’s rare that the over-70 crowd is wanted for more than filling assisted living facilities and listening to financial advisors.
However, coronavirus is changing how we view many things these days, and America’s seniors are no exception. They are learning how to be this year’s newest desired commodity.
The possibility of developing dangerous symptoms from COVID-19 increases with age, with those who are age 85 and older facing the highest risk. In the U.S., about 80% of deaths related to COVID-19 have been by people age 65 and older, according to Johns Hopkins University researchers. Risks are even higher for older people when they have underlying health conditions, such as heart disease, diabetes or long-term lung disease, suggest Hopkins’ researchers.
For one thing, doctors suggest that since many seniors don’t develop as strong an immune response to vaccines. So participation by seniors in clinical trials testing COVID-19 treatments is critical. It is essential to evaluate how coronavirus vaccines work for our most “at risk” population — older adults.
But Harvard researcher and physician Sharon K. Inouye points out “older adults, particularly those in their 70s and 80s, may be systematically excluded from clinical trials …”
Seniors tend to be more difficult to reach than other potential trail subjects and seniors often show little interest in participating in something they know little about.
Inouye says her team’s “biggest concern is that without clinical trial testing, older adults may ultimately be denied treatments and vaccines — based on safety concerns. If that were to happen,” she said, “… equitable distribution to [a diverse] population will not be possible…”.
It would be, she said, “an egregious oversight.”
Two volunteers share their trial experiences
Two contemporaries of mine have recently volunteered for phase-3 vaccine clinical trials. We’re not using their names because their trials remain ongoing. One is 80 and the other 72 and both have a strong interest in the latest technology and thrive on being inquisitive.
“I have always ‘volunteered’ for interesting community activities and this aroused my curiosity,” the 80-year-old said. “Generally, I turn these adventures into a learning experience. Like most of us, I had been following the COVID-19 disease as it continued to build across the country.”
He says he modified his lifestyle by avoiding potentially infectious situations, like getting a haircut, and trying to learn what he could from media reports and “official” information.
“It didn’t take long for me to look for ways I could help and the opportunity to participate in one of the vaccine trials seemed just right. I found their website, signed up and waited.” He said he got the call about two weeks later and took the first appointment the trial offered.
The 72-year-old learned of the trial from the 80-year-old, who is a friend. “Since retiring, I have done a great deal of volunteer work in a variety of settings,” the younger man said in an email. “With the pandemic, many of my volunteer activities dried up as Atlanta events were canceled over this past spring and summer.”
“I was trying to find other ways to give back and a vaccine trial looked like a way I could make a contribution, not just in my community, but on a far wider scale,” he said. “I did discuss the trial with my primary doctor as well as with our church’s wellness director (an RN) and got a couple of “atta-boys.”
Improving inclusion and diversity
According to University of Georgia researchers, the pharmaceutical industry struggles to recruit trial participants from a number of groups. Their concern is in attracting racial and ethnic minorities and especially elderly women.
One difficulty is projected patient outcomes cannot represent the general population, if racial or ethnic minorities have been excluded in the past (often inadvertently). Barriers to under-representation include trust, awareness, transportation, time away from home or work, and a basic understanding of often complex consent requirements. The legal language can also be a challenge.
As of 2012, (in the U.S.), Congress required the Food and Drug Administration to report on the diversity of participants in clinical trials. A major focus must be based on safety and effectiveness, which address such factors such as gender, age and race.
The coronavirus has brought the problems related to diversity to the forefront. In a recent New England Journal of Medicine article, the authors state, “Despite widespread underreporting of patients’ race or ethnicity, we know that Black, Latinx, and Native Americans are dying from COVID-19 at rates disproportionate to their representation in the (U.S.) population.”
Views from participants
“The trial I’m in is being conducted carefully and professionally the 72-year-old volunteer said. “Each step is thoroughly explained and well documented. The people are very friendly and appreciative of what the volunteers are doing. “We are thanked at every step of the way. If any complications or symptoms happen to appear, which I certainly don’t anticipate and haven’t personally experienced, the folks running the trial seem well prepared to deal with it.”
“For me, it’s turning out to be interesting, and in some respects, fun,” the 80-year-old said. “My current role is to observe and report how I feel.” He also will need to provide blood samples from time to time.
“So far, it’s intellectually stimulating, and I hope useful to mankind in the long run. Although I don’t know if what I received was the “real thing” or a placebo, but now I have a bit of a feeling that I am like Superman and invincible to COVID-19. The trial will officially run for about two years, but the results, leading to release of the product will be known much sooner, probably in a matter of months,” he said.
Although both are older than 70, white and male, they still represent an important component of the senior population in the U.S. What’s still missing is racial diversity and older women.
But the gap may be closing. According to one company, as of August 21, about 18% of the participants in a clinical trial were Black, Latinx, American Indian or Alaska Native. But as of Oct. 2, about 33% were from those communities.
Want to sign up for a clinical trial?
If you or anyone you know who is older than 70 and interested in participating in coronavirus prevention research, check PreventCOVID.org/. Persons without internet access or who do not feel comfortable with online forms can call 866-CVT-1919 (866-288-1919).