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FRIDAY, Oct. 2, 2020 (HealthDay News) — Older adults are likely to be excluded from many COVID-19 clinical trials and all vaccine trials, according to a research letter published online Sept. 28 in JAMA Internal Medicine.

Benjamin K.I. Helfand, from the University of Massachusetts Medical School in Worcester, and colleagues reviewed all COVID-19 treatment and vaccine trials on www.clinicaltrials.gov to assess their risk for exclusion of older adults (โ‰ฅ65 years).

The researchers observed considerable variability in age exclusions among the trials. Overall, 23 percent of the 847 trials included an age cutoff. The most common age-related exclusion was compliance concerns (219 trials); 129 of these concerns were related to consent, followed by broad nonspecified exclusions, specific comorbidities, requirement of technology, and other reasons. Fifty-three percent of trials were considered high risk for excluding older adults when combining the results of age-based exclusions and exclusions preferentially affecting older adults. Sixteen percent of the 232 phase 3 clinical trials included age cutoffs and 33 percent had exclusions preferentially affecting older adults; consequently, 50 percent were considered high risk for excluding older adults. Eleven of 18 vaccine trials included age cutoffs, and the remaining seven had broad nonspecified exclusions; consequently, all were considered high risk for excluding older adults.

“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,” the authors write.

Abstract/Full Text

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