Why are Clinical Trials for Coronavirus Excluding Older Adults?

At the moment, various clinical trials for coronavirus are reporting positive results and raising hopes of the medical community and the general public around the world. However, experts have stated that there may be a number of problems with the setting of some of the trials, such as the exclusion of certain groups including older adults.

Statistically, older adults over the age of sixty-five make up around nine percent of the global population. Furthermore, thirty to forty percent of the coronavirus and eighty percent of the coronavirus-related deaths are also of this age group, which is why experts have emphasized the importance of preventive measures for older adults.

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Although there are multiple groups who have a higher risk of coronavirus infection, people over sixty are most likely among all to develop severe complications, be admitted to the Internal Care Unit, and lose their lives to the infection.

One would think that most of the major clinical trials on the coronavirus would then include a big number of older adults as they are most affected by the virus and the ongoing pandemic. However, research from the Journal of American Medical Association shows that nearly all clinical trials are specifically choosing younger and healthier participants who have a lower risk of dying than older adults.

Why is this so? There can be multiple reasons to not include certain groups as participants in a clinical trial the most common being safety. Many times, the trial testing a specific vaccine or a drug for a pathogen chooses people who are unlikely to develop negative consequences due to the trial.

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So, people who have existing health conditions are also excluded as their life can be put in danger due to the tested formulas.

In addition to these, other trials may have a random selection that may exclude older adults more or have requirements that people over sixty-five usually cannot meet. For example, some trials require the participants to understand the latest technology and own smartphones for entering data or using specific apps for record-keeping as well.

However, in clinical trials for vaccines, it is usually recommended to test a potential formula on multiple age groups ranging from children to adults as vaccines for the control of an outbreak or epidemic are needed by the entire population.

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In fact, the U.S. Food and Drug Administration urges clinical trials to include minorities and marginalized groups such as older adults over the age of sixty-five, ethnic and racial minorities, pregnant women, and people from lower socio-economic backgrounds.

To do this, many companies still prefer to not include the aforementioned groups as there is also no mandate requiring them to do so. While some times certain participants have to be excluded for their own safety, companies are also known to recruit healthier participants for fast approvals.

Clinical trials for coronavirus may not include older adults because they are more likely to develop side effects or complications from the vaccination which can prolong or keep a formula from getting an FDA approval. This exclusion may affect at-risk groups in the future when a vaccine is released into the market.

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