For decades, clinical trials were criticized for failing to enroll elderly patients.
There is a growing recognition that this pattern is bad for science and public health. For decades, clinical trials were criticized for failing to enroll elderly patients, who are more likely than younger people to have chronic diseases and be taking multiple medicines. More recently, scientists have been faulted for not including enough racial and ethnic minorities in clinical trials—even though their participation could raise the odds of identifying subgroups that may respond differently to a drug or device.
As of 2016, about 15% of Americans were over 65. More than half had one or more chronic conditions; almost a third had two or more. One-third of people over 85 lived with Alzheimer’s disease or another dementia; many others suffered from heart failure, arthritis, cancer, diabetes and/or lung disease. While it would be logistically challenging to enroll every older American in clinical trials if they wished to participate (and many prefer not to), the current numbers are startlingly low: fewer than 4% of participants in industry-sponsored drug trials are over 65 years old; only 5% are 75 or older (and women make up only one-quarter of those).
But when researchers did finally consider age when designing trials, they still missed a big part of the population.
But when researchers did finally consider age when designing trials, they still missed a big part of the population.
Clinical trials that recruit people who are older than 65 years old, or who have chronic diseases, are often not powered to detect small differences in outcome. It would be very difficult to identify a difference between two treatments if only 50 people with heart failure are enrolled in each study arm and half of them die within six months. So, the burden of conducting highly powered studies falls on the shoulders of healthier patients—even though mainly elderly and sicker individuals will ultimately take these treatments after they have been approved by the FDA.
The fact that people are living longer means that as the population ages, more and more people will have chronic diseases like cancer, diabetes, arthritis and heart disease.
As the population ages, more and more people will have chronic diseases like cancer, diabetes, arthritis and heart disease. The fact that people are living longer means that as the population ages, more and more people will have chronic diseases like cancer, diabetes, arthritis and heart disease. This means we need to include older patients in clinical trials so we can learn how to treat them better. We also need to include people with chronic diseases in clinical trials so we can learn how to treat them better.
The problem is that the vast majority of drugs approved by the FDA are based on evidence from studies that don’t reflect the reality of an aging population.
The study below is one of the first to include a broad spectrum of ethnic groups. It was not only included in a clinical trial to test the effectiveness of a new diabetes medication, but also provides some insight into how we can better identify which drugs are likely to be effective for different racial and ethnic populations.
Considering the fact that many drugs are approved by the Food and Drug Administration (FDA) based on studies conducted with middle-aged or elderly white men, it’s important to note that there is a dearth of clinical trials looking at older populations. Only about 10 percent of all clinical trials over 40 years old were published in 2016, according to an investigation by STAT News. This is concerning because drug approval doesn’t just affect older adults; it shapes what treatments are available for everyone else—especially when it comes to chronic diseases like diabetes and heart disease.
The Alzheimer’s Disease Research Center from Virginia Commonwealth University recently completed an open-label trial that offered patients either the drug Namenda (memantine), or placebo pills without any active ingredients in them at all. Researchers tracked their reactions by checking blood samples every six hours during the three month study period and found that both groups experienced similar declines in brain volume as they aged, regardless whether they received Namenda or placebos—but those who took Namendra showed signs of improvement sooner than those who took placebos. In other words: taking memantine actually made these people feel less impaired than if they had taken placebos—and this was true even though memantine had no nutritional value whatsoever!
In general, drugs should be tested on people with different ethnic backgrounds than their target audience because this will give them more accurate results regarding efficacy, safety, and side effects. If you have questions about which medications work well for you, ask your doctor about drug interactions before you start taking prescription medications—this will help prevent adverse drug reactions before they even happen!
Very often you’ll hear about drug trials for these types of diseases not being “powered” to detect differences in older people.
You may hear the term “powered” in conjunction with clinical trials. Being “powered” is a statistical term referring to having a large enough sample size to detect a difference between two groups–usually between people who are receiving an experimental drug and those who aren’t. If a trial is not “powered”, it means that the trial is too small to detect differences between these two groups.
There are many reasons why clinical trials might be under-powered, or have too small of a sample size. One reason is that clinical trials often exclude older people because they are generally more frail and take more medications, making it harder to isolate the effect of an experimental drug on them. This makes sense for smaller studies, which want to keep their study populations as streamlined (and healthy) as possible so that they can maximize the number of data points collected from each participant. Unfortunately, this practice is detrimental to older people in two ways: 1) without being included in more trials, older people end up receiving less effective treatments due to not having been adequately studied; 2) by excluding most older people from participating in trials, researchers miss out on data from many different races and ethnicities that may be needed for future studies.
In an article published in JAMA Internal Medicine in 2012, Dr. Steven Nissen of Cleveland Clinic used the example of a statin drug that had been tested in 14,000 men and women who were on average 51 years old with LDL (bad) cholesterol levels of about 130 mg/dl.
In an article published in JAMA Internal Medicine in 2012, Dr. Steven Nissen of Cleveland Clinic used the example of a statin drug that had been tested in 14,000 men and women who were on average 51 years old with LDL (bad) cholesterol levels of about 130 mg/dl. “This is not the real-world population,” he said. The drug was approved by the FDA with no data to show how it would perform in patients over 75 or those with preexisting heart disease or diabetes.
Statin trials generally don’t include people who take other medications, either; trial patients are rarely “clean” because they haven’t taken other drugs for a certain period before enrolling. But such restrictions mean that results may not be relevant when a trial participant starts taking multiple medications for chronic conditions later on.
Many trials also exclude people who have other ailments (which makes sense, because the research is seeking to control as many variables as possible). However, that means we might never know whether statins are effective treatments for people with multiple health conditions—a group that includes many older adults and people with disabilities.”
It was approved by the FDA with a label that said it reduced heart attacks and strokes by “approximately 20 percent.”
One example of this is a drug approved by the FDA in 1998 that was advertised with a label that said it reduced heart attacks and strokes by “approximately 20 percent.” According to some of the company’s own literature, however, the drug was actually shown to prevent heart attacks and strokes only by an average of 5 percent. The wording on the labeling allowed for more dramatic marketing.
The FDA routinely allows for labeling language that intentionally skews public perception about a drug’s efficacy or safety. A former senior official at FDA who had served in four administrations told me he believed these practices are so common as to be “standard operating procedure” for most drugs approved by the agency.
So how would this drug work in someone older than 65 who had heart disease and whose cholesterol was above 200 mg/dl?
Having a diverse population of participants in clinical trials will give doctors more information about who the drugs will work for. For example, if a drug’s label says it treats heart disease, the doctor might assume it would work in older people with heart disease. But we don’t know if this drug would be safe or effective in someone over 65 with high cholesterol because that person wasn’t included in the trial. We need to do more research on how drugs affect different populations so that doctors can prescribe them safely and effectively.
With more diversity in clinical trials, we’ll also start seeing more prescription drug labels like this: “For healthy people aged 18-35 with low blood pressure, this drug works very well and has no serious side effects. For patients aged 65 and older with high blood pressure, it’s unclear whether this drug is helpful or harmful at all because there weren’t enough seniors enrolled in our clinical trial.”
We don’t know because those people weren’t included in the trial.
For example, the FDA doesn’t require drug companies to show how their drugs work in older people. If a drug hasn’t been tested in older people and they then experience a bad reaction to it, there is no case against the pharmaceutical company because they have no data on that population. That makes no sense!
Another example? There is a lack of racial diversity in clinical trials. If you haven’t noticed, black people—and really all people of color—are underrepresented in clinical trials to such a degree that scientists and doctors can’t answer questions about how certain medications interact with certain genes. This means doctors can only guess when prescribing medication based on what little data is available for that group of people. And if the guess goes wrong and something terrible happens to the patient? The worst thing is that it could easily be fixed by being more inclusive during the drug-testing phase.
Additionally there is a lack of racial diversity in clinical trials
There is a lack of racial diversity in clinical trials. According to the National Institutes of Health (NIH) website, African Americans have been underrepresented for decades. In 1993, the NIH established a policy that required investigators to include women and minorities in research. However, this did not fully solve the problem of diversity within the field.
According to an article from Vox, there are many reasons why African Americans may choose not to participate in clinical trials. One reason could be they do not trust medical researchers because they have unfairly been denied medical care or participated in unethical research studies like the Tuskegee experiment where researchers let African Americans with syphilis go untreated so they could study what would happen if left untreated.