Exclusion of Older Persons From Vaccine, Treatment Trials for Covid19—Missing the Target

Benjamin K. I. Helfand, MSc^1,2; Margaret Webb, BA³; Sarah L. Gartaganis, MSW, MPH³; et al

doi:10.1001/jamainternmed.2020.5084

Older adults are at greatest risk of severe disease and death due to coronavirus disease 2019 (COVID-19). Globally, persons older than 65 years comprise 9% of the population,¹ yet account for 30% to 40% of cases and more than 80% of deaths.²

Unfortunately, there is a long history of exclusion of older adults from clinical trials. In response, the National Institutes of Health instituted the Inclusion Across the Lifespan policy, requiring the inclusion of older adults in clinical trials.³ Thus, we reviewed all COVID-19 treatment and vaccine trials on http://www.clinicaltrials.gov to evaluate their risk for exclusion of older adults (≥65 years).

Results

Table 1 identifies clinical trials by treatment with an exclusion by age. We found large variability in the age exclusions. Among the 847 trials, 195 (23%) included an age cut-off.

Table 2 displays indirect age-related exclusions preferentially affecting older adults; each trial could have multiple exclusions. The most common age-related exclusion was compliance concerns (213 trials), and 129 of these were related to consent. Next, were broad nonspecified exclusions, specific comorbidities, requirement of technology, and other reasons. A total of 366 (43%) trials had any exclusions, of which 252 (30%) did not have an age-based exclusion. Combining the results of age-based exclusions (Table 1) and exclusions preferentially affecting older adults (Table 2), 447 (53%) trials were considered high risk for excluding older adults.

In 232 phase 3 clinical trials, 38 (16%) included age cut-offs and 77 (33%) had exclusions preferentially affecting older adults; thus, 115 (50%) were considered high risk for excluding older adults. Of 18 vaccine trials, 11 (61%) included age cut-offs, and the remaining 7 had broad nonspecified exclusions; thus, 100% were considered high risk for excluding older adults.

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091