The Exclusion Of Older Persons From Vaccine And Treatment Trials For Coronavirus Disease 2019—Missin

In view of a long history of exclusion of older adults from clinical trials, researchers here reviewed all COVID-19 treatment and vaccine trials on http://www.clinicaltrials.gov with the aim to determine their risk for exclusion of older adults (≥ 65 years). At least 1 trained research associate abstracted each of the 847 clinical trials, with reliability checks of all ratings. All of the eligibility and exclusionary criteria were viewed to identify age exclusions. Findings indicated the likely exclusion of older adults from more than 50% of COVID-19 clinical trials and 100% of vaccine trials. Such exclusion will restrict the potential to examine the efficacy, dosage, and adverse effects of the intended treatments. Some exclusions for severe or uncontrolled comorbidities will be described as necessary to protect the health and safety of older adults. However, caution must be practiced to limit exclusion of otherwise eligible participants for rationale that are not well-justified.

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