A group of prominent researchers from Boston and New York remind all that the elderly represent the group in the most danger from COVID-19. Worldwide, the population of those 65 and older is about 9% of the total yet they account for 30% to 40% of COVID-19 cases and over 80% of the deaths. Clinical research traditionally shuns the elderly and it’s exactly this cohort that should be more involved and engaged in clinical trials, at least concerning COVID-19. Consequently, the National Institutes of Health (NIH) instituted the Inclusion Across the Lifespan policy, mandating that older adults participate in COVID-19-based clinical trials. The investigators reviewed all COVID-19 trials to assess the government and industry’s performance.
Older adults are most often excluded from clinical trials. The elderly are excluded from 50% or more of COVID-19 research focusing on therapeutics while they are 100% excluded from vaccine trials. Such exclusion not only limits the ability for sponsors to evaluate the efficacy and dosage of treatment but, importantly, also the adverse effects of this vulnerable population in relation to future COVID therapies.
The researchers acknowledge significant limitations, such as the fact that some exclusions for severe or uncontrolled comorbidities are required for the health and safety of subjects. The study authors couldn’t fully analyze every study’s protocol for comorbidity hence they couldn’t’ analyze the appropriateness of many comorbidity exclusions.
If sponsors continue to systematically preclude the elderly, it just won’t be possible to effectively ensure not only efficacy, titrate dosage or frequency but also establish even a basic safety profile for COVID-19 vaccines and therapies for the vulnerable elderly population.
National Institute of Aging and University of Massachusetts Medical School
Sharon K Inouye, MD, MPH, Marcus Institute for Aging Research, Hebrew SeniorLife, Boston MA