Clinical Trial Participation Part 2: The second of an ongoing series of articles examining critical issues concerning clinical trial participation

Lack of Elderly Participation in Clinical Trials

In part two of this ongoing series, we turn to the issue of the lack of elderly participation in clinical trials. According to the Administration on Aging, there are approximately 39.6 million people or 12.8 percent of the population who are over the age of 65 in the United States. By 2030, it is anticipated that this number will grow to about 72.1 million.

Despite representing such a large population in this country, statistics show that there is limited to little data on how many drugs or medical procedures work in older men and women. Many clinical studies exclude older, sicker patients.

However, the prevalence of conditions such as Alzheimer’s disease, high blood pressure, diabetes, and atrial fibrillation all increase as people age. But due to declining liver and kidney functions, some medicines used to treat these conditions and others may work differently in elderly patients and may even cause harmful side effects. In fact, a recent article in the Boston Globe reports that many physicians are essentially making extrapolations on the dosing of certain medications that may not be appropriate.

We know there isn’t a one-size-fits-all approach when prescribing medication to children. Some drugs such as sleep medications have recently changed the initial dosage for women. Wouldn’t it be nice to know how common medications work in people over 65, or even 75 years of age?

Geriatric Exclusivity?

Since 1997, the U.S. Food and Drug Administration (FDA) has incentivized drug manufacturers to study their medications in children in return for a six month extension on patent exclusivity, meaning companies have an extra six months of selling their branded product before a generic product can hit the market.

In 1989, it looked like the FDA was staking measures to look into this issue. It set guidelines encouraging pharmaceutical companies to study how their products work in the elderly, but it was not a mandate. What if the FDA formally introduced a process for geriatric exclusivity? If it added as little as six months more (in addition to the pediatric exclusivity) or even up to a year or two more, do you think it would encourage drug manufacturers to conduct studies in the elderly?

I’m interested in hearing whether or not you think a so-called Geriatric Exclusivity would work. Would it encourage the study of medications in the elderly?

Please provide your thoughts, comments, or feedback on this topic so that we can begin a healthy exchange.