Fifty percent of phase 3 clinical trials and 100 percent of vaccine trials at risk for excluding older adults
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 (≥65 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.
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