Older adults are likely to be excluded from many COVID-19 clinical trials and all vaccine trials, a research letter published online in JAMA Internal Medicine has noted.
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 cut-off.
The most common age-related exclusion was compliance concerns (219 trials); 129 of these concerns were related to consent, followed by broad non-specified 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 cut-offs 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 cut-offs, and the remaining seven had broad non-specified exclusions; consequently, all were considered high risk for excluding older adults.
“With advanced preparation, staff training, and aging expertise, enrolment of older adults is feasible, allowing COVID-19 clinical trials to be as relevant and inclusive as possible,” the authors wrote.
REFERENCE: Helfand et al: The Exclusion of Older Persons From Vaccine and Treatment Trials for Coronavirus Disease 2019—Missing the Target; https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091