Older people likely to be underrepresented in COVID-19 trials, says study
Posted: 29 September 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
Researchers suggest, based on certain exclusions, older people are likely to be underrepresented in 50 percent of COVID-19 trials and all vaccine trials in the US.
According to new study, older people are highly likely to be excluded from 50 percent of US COVID-19 trials testing potential treatments and 100 percent of those evaluating vaccines. The study said this is despite the fact that people over 65 are disproportionately impacted by COVID-19; while only accounting for nine percent of the global population, older people account for 30 to 40 percent of COVID-19 cases and 80 percent of COVID-19 deaths.
The researchers examined how often COVID-19 clinical trials registered in https://www.clinicaltrials.gov/ between 1 October 2019 and 1 June 2020 did not include older people. They reviewed direct age-based exclusions or exclusions that preferentially affect older persons (eg, the presence of other diseases or requiring Internet or smart phones to participate) to draw their conclusions.
According to the study, older adults are highly likely to be excluded from more than 50 percent of COVID-19 clinical trials and 100 percent of vaccine trials, despite their inclusion being critical to ensure the development of effective treatments/vaccines, decide appropriate doses and ensure equitable access to treatments. The researchers are particularly concerned that excluding older adults from these trials may lead to treatments that are ineffective and potentially toxic in conjunction with the physiological changes that occur with advancing age.
“To be sure, some exclusions are needed to protect the health and safety of older adults– such as poorly controlled comorbidities,” said Dr Sharon Inouye, senior author on the study and Director of the Aging Brain Center in the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife (an affiliate of Harvard Medical School). “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 was published in JAMA Internal Medicine.
Related topics
Clinical Trials, Drug Safety, Industry Insight, Recruitment, Therapeutics, Vaccines, Viruses
