A research letter published in JAMA Internal Medicine Sept. 28, co-authored by a UMass Medical School MD/PhD student, reports that older adults were likely to be excluded from more than half of COVID-19 clinical trials and 100 percent of vaccine trials initiated early in the pandemic.
That finding is alarming, according to Benjamin Helfand, SOM ’22 and a PhD candidate, because eight out of 10 COVID-19 related deaths in the United States have been among people 65 or older, the Centers for Disease Control and Prevention report.
“I think it’s really important to make sure that we’re enrolling older people in trials,” Helfand said. “To see that more than 50 percent of the time, they’re potentially excluded–we want to understand why and make sure it’s justified. They’re the ones who are getting impacted with the most morbidity and mortality.”
He said including older adults in trials is also critical to understanding the efficacy, dosage, and side effect profile and whether older persons and physicians administering these treatments would accept them without proper testing in this target population.
The study’s co-authors are Margaret Webb, Sarah Gartaganis, MSW, MPH, and Lily Fuller of Harvard Medical School and Hebrew SeniorLife, Boston; and Churl-Su Kwon, MD, MPH, of the Icahn School of Medicine at Mount Sinai, New York. The senior author is Sharon K. Inouye, MD, MPH, director of the Aging Brain Center in the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife.
Researchers examined 847 trials registered between Oct. 1, 2019 and June 1, 2020, with reliability checks of all ratings. Among these, 23 percent had an age cutoff that explicitly excluded older adults.
The authors identified other study criteria that were likely to exclude older persons. The most common age-related exclusions were compliance concerns (213 trials) and 129 of these were related to consent. Next were broad, nonspecific exclusions, specific comorbidities, technology requirements and other reasons.
Helfand said there were legitimate reasons to exclude some people, such as those with dementia or severe mental status issues; or those with high-risk comorbidities such as uncontrolled diabetes. But researchers were unable to determine in many of the studies whether the exclusions were justified or whether trial researchers even attempted to work with caregivers or proxies, excluded seniors who had communication challenges or were not equipped to use technology such as smartphones. Many trials also used statements such as “any condition that the investigator considers ineligible for clinical trials” or didn’t specify severity of comorbidities, instead only listing exclusions like any diabetes or hypertension.
Some of these issues could be avoided in future research by factoring in the needs of older adults in the planning process, Helfand said, a process that would be consistent with the National Institutes of Health’s Inclusion Across the Lifespan policy. He suggested including a geriatrician, social worker or another professional who has experience working with older populations in the research design.
The authors concluded that with advanced preparation, staff training and aging expertise, enrollment of older adults is feasible, allowing COVID-19 clinical trials to be as relevant and inclusive as possible.