Exclusion Poses Risk to Potential Treatment Efficacy and Safety for Older Persons
BOSTON – A study published today in the Journal of the American Medical Association Internal Medicine revealed that older persons are highly likely to be excluded from the majority of COVID-19 trials that seek to establish effective treatments, as well as find a preventive vaccine. This is despite the fact that older persons are overwhelmingly impacted by COVID-19. Globally persons 65 and older make up nine percent of the population, yet account for 30 – 40 percent of COVID-19 cases and 80 percent of COVID-19 deaths. Sharon K. Inouye, M.D., M.P.H., Director of the Aging Brain Center in the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, is senior author on the study.
Researchers viewed how often all the COVID-19 clinical trials registered in https://www.clinicaltrials.gov/ 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.
According to the study, 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. The researchers who participated in this study are particularly concerned that exclusion of older adults from clinical trials may lead to treatments that are ineffective but may even be toxic for older adults.
“To be sure, some exclusions are needed to protect the health and safety of older adults-- such as poorly controlled comorbidities,” said Dr. Inouye. “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.”
The study coauthors included Benjamin Helfand, MSc, of the University of Massachusetts Medical School, Margaret Webb, Sarah Gartaganis, M.S.W, M.P.H., and Lily Fuller of Hebrew SeniorLife, and Churl-Su Kwon, M.D., M.P.H of the Icahn School of Medicine at Mount Sinai.
This study was supported in part by Grant R24AG054259 (SKI) from the National Institute on Aging and T32GM107000 (BKIH) [MD/PhD (MSTP) Training Program at the University of Massachusetts Medical School (UMMS)]. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
About the Hinda and Arthur Marcus Institute for Aging Research
Scientists at the Hinda and Arthur Marcus Institute seek to transform the human experience of aging by conducting research that will ensure a life of health, dignity, and productivity into advanced age. The Marcus Institute carries out rigorous studies that discover the mechanisms of age-related disease and disability; lead to the prevention, treatment, and cure of disease; advance the standard of care for older people; and inform public decision-making.
About Hebrew SeniorLife
Hebrew SeniorLife, an affiliate of Harvard Medical School, is a national senior services leader uniquely dedicated to rethinking, researching, and redefining the possibilities of aging. Based in Boston, the nonprofit organization has provided communities and health care for seniors, research into aging, and education for geriatric care providers since 1903. For more information about Hebrew SeniorLife, visit http://www.hebrewseniorlife.org and our blog, or follow us on Facebook, Instagram, Twitter, and LinkedIn.