Study finds elderly underrepresented in COVID-19 treatment and vaccine trials
Older persons are highly likely to be excluded from many novel coronavirus (COVID-19) trials that seek to establish effective treatments and a preventive vaccine, despite elderly being overwhelmingly impacted by the virus, according to a new study published in the Journal of the American Medical Association Internal Medicine.
For the study, researchers viewed how often COVID-19 clinical trials registered in the U.S. National Library of Medicine clinical trials database from October 1, 2019 to June 1, 2020 did not include older people. This was determined by reviewing direct age-based exclusions or exclusions that preferentially affect older persons, such as the presence of other diseases, or requiring internet or smart phones to participate. Their findings indicate that older adults are highly likely to be excluded from more than 50 percent of COVID-19 clinical trials and 100 percent of vaccine trials.
Inclusion of older adults in clinical trials is critical to ensure equitable access to these treatments, the researchers said. It is important that COVID-19 clinical trials enroll older persons to ensure effectiveness of treatments and to find the proper dosing in this age group, which can be different from other age groups due to physiological changes that come with age.
“To be sure, some exclusions are needed to protect the health and safety of older adults-- such as poorly controlled comorbidities," said Sharon Inouye, MD, MPH, senior author of the study, in a statement. "However, many are not well-justified, and appear to be more for expediency or convenience of the trialists. We are concerned that the exclusion of older adults from clinical trials will systematically limit our ability to evaluate the efficacy, dosage, and adverse effects of COVID-19 treatments in this population.”