Older adults are routinely excluded from participating in COVID-19 clinical trials, according to a preliminary study at Harvard Medical School. The Daily interviewed Marina Martin, an assistant professor and section chief of Geriatric Medicine at Stanford Medicine, to learn about the implications of elderly underrepresentation in clinical trials, particularly for a virus that sees 8 of 10 deaths occurring in adults over the ages of 65.
The ongoing study, led by medicine professor Sharon Inouye at Harvard Medical School, examines ageism in clinical research and shows that around 15% of clinical trials for COVID-19 systematically exclude adults between the ages of 65 and 80.
Martin noted that elderly underrepresentation in trials may lead to inaccurate data and additionally worsen crisis conditions for older adults, who are already among the most vulnerable to complications of the virus.
“With vaccine research, if we only test a vaccine in a younger population, we run the risk of having a vaccine that doesn’t work on older adults,” Martin said. “And then, the most vulnerable population will still be at an increased risk and will remain a group in which the virus can thrive and proliferate.”
An additional 12% of the trials evaluated in the study indirectly excluded older adults by disqualifying people with health conditions that disproportionately affect the elderly, such as hypertension and diabetes.
Researchers and medical professionals attribute the exclusions to the higher number of comorbidities found in older adults, such as dementia, which can potentially lead to challenges in conducting the studies.
“[Dementia] becomes increasingly prevalent with age,” Martin said. “And that complicates research protocols … There are issues with the ability to give informed consent in older adults with cognitive impairment, and also the ability to report on side effects may be affected. So that makes patients with cognitive impairment especially difficult to study in clinical trials.”
Still, Martin notes that many studies mainly exclude older adults out of convenience and obtaining quicker results, since results are usually easier to interpret with a younger generation. With healthcare professionals racing to develop a vaccine for the virus, COVID-19 researchers face the problem of balancing the need for quick, effective study results while also making trials diverse and inclusive, which can slow down research.
“We’ve seen problems from going to both extremes of far too easy approval of medications or trials, and also too difficult or slow, such that it was impractical,” Martin said. “As we gain more information about the virus and potential treatments and have more to go on, I think the burden of responsibility for making sure that trials are inclusive goes up. We’re not as uninformed as we were, and we should take that into account.”
There are ways for researchers to get around these difficulties and use a more diverse range of patients in their search for a COVID-19 treatment. More and more older adults today live longer and healthier lives, and Martin says they should be taken into account in clinical trials more often as a way to gauge the effect of the treatment in older populations.
“We have people in their 80s and 90s, who are quite functional and healthy and on minimal medications, with maybe one or two comorbidities that are pretty common in younger people too, like high blood pressure, that could participate in these trials,” Martin said. “But their physiology may have changed with normal aging, and so they would better represent what a drug might do to an older person, as our bodies just change with time from birth to death.”
Steps can also be taken to redesign the studies themselves and their recruitment strategies to be more older-adult friendly. In 2017, the NIH rolled out a new policy requiring the studies they fund to disclose their plans for including participants of all age groups, or to provide acceptable scientific justifications for excluding them.
Age exclusions are not limited to COVID-19 research and have historically been seen in clinical trials for many other conditions, including cancer. While progress has been made over time, Martin hopes the ongoing COVID-19 studies are a chance for researchers to take a step in the right direction for age diversity in trials.
“History would show that many trials did exclude important groups, and much of our data that we use today to form guidelines for clinical practice comes from trials that were not representative of the population,” Martin said.
“I know that there have been some efforts to make sure we do broader research but we have a long way to go still,” Martin added, “and I hope that COVID-19 is not used as a loophole for going backwards because we are in a rush to get a treatment.”
Contact Emma Stefanutti at stefanuttiemma ‘at’ gmail.com.