Older adults have historically been excluded from clinical trials that test new drug treatments, even though older adults are most likely to need these treatments. Pratibha Gopalakrishna reports for StatNews that the problem continues. Even most reported Phase 3 COVID-19 clinical trials do not include older adults.
Treatments should be developed with the needs of older Americans in mind, both in a pandemic and more broadly. Older adults have higher disease rates than younger people. The disproportionate number of deaths of older adults during this pandemic illustrates just how hard hit older adults can be from a transmissible disease.
When older adults are not included in a clinical trial, it is much harder to know whether a drug will work for them, how safe the drug is, what the side effects might be, or how high a dosage they need. They might react very differently to a drug than a younger person.
In January 2019, the National Institutes of Health released the Inclusion Across the Lifespan Policy. It requires that researchers include older people as well as younger people in their trials, if they are using NIH funding, unless there is a scientific or ethical reason not to. But, at least with cardiovascular trials that have taken place since this new policy, one in three trials still had age limits.
In addition, some cardiovascular trials studied used exclusion criteria that were not age-specific. But, these criteria excluded people with pre-existing conditions, which includes most older adults. And, most studies were not looking to see whether a treatment benefited older adults.
Perhaps, over time, the new NIH policy will bear fruit and do more to ensure new treatments are tested with older adults in mind. But, some experts say that a lot of the research is done on participants who are much younger on average than the age of people with serious diseases.
Of course, in some cases, it may be perfectly appropriate to exclude older people from a trial because of risks of drug interactions, as well as compliance concerns, or inability to consent to the study. On top of these challenges to including older adults in clinical trials, there are challenges with identifying and recruiting older adult participants, along with transportation challenges.
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