Inclusion of Seniors in Clinical Trials and Research

Inclusion of Seniors in Clinical Trials and Research


Dr. Ken Covinsky, a researcher and geriatrician, was browsing through a medical journal in his office in the San Francisco VA Medical Center when a study on sodium excretion caught his eye. Anything related to salt matters to geriatricians. The research was conducted by a team from the Centers for Disease Control and Prevention which used urine samples collected over a 24-hour period to estimate how much salt Americans consume every day.

The study seemed great until Dr. Covinsky reached the part explaining that the test subjects comprised of randomly selected participants aged 20-69 years. Once again, an important study that had the potential to become a great resource for geriatricians was neglecting the most affected people; older adults. For years, geriatricians have complained of the hardships they face figuring out treatments for their patients. This becomes even harder when the older people are left out of important research and clinical trials. When asked why the study excluded older people, the CDC said elderly people were less likely to take part in 24-hour urine collection.

According to Dr. Covinsky, there was no good rationale for the exclusion. Clinical trials performed on people in their fifties could hardly be of any use when dealing with an 85-year-old who probably has several diseases. Sadly, this trend is common in many studies including those for diseases that commonly affect seniors. In most clinical trials for cancer, diabetes or osteoporosis, older people are hardly included. As a result, doctors resort to extrapolation which, in other words, is guesswork.
Dr. Covinsky and other supporters of age inclusion in medical studies had a lot to smile about in December then the National Institutes of Health issued revised policy guidelines for all research under its funding. From January, all grant applicants must explain how they will include people of all ages in their studies. If they decide to leave an age group out, they will have to provide acceptable justifications. The agency will monitor every research project to ensure they comply.
This move was heavily lauded by many doctors, including those serving the other end of the spectrum. Dr. Florence Bourgeois, a Harvard Medical School pediatrician saw the NIH move as a step in the right direction. For years, many medical studies have also excluded young kids, resulting in children having to take drugs tested only on adults. While this is all good news, Dr. Bourgeois emphasized the need for a culture shift in society to make people realize the importance of inclusivity in medical research.

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Leo G. Anderson

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