Clinical trials are research studies on new medical treatments and their effects on people with specific health issues. Usually, all study participants must have the same condition and have had similar treatments to one another. In addition, to make the trial accurate and objective, trial volunteers should also be at the same level of physical health.
Despite these minimal requirements, there is a marked lack of diversity in many clinical trials. How much does this affect trial results, and what can we do to fix the problem?
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Clinical trials benefit both healthcare research and the participants in several ways. Clinical trial volunteers get first access to life-changing treatments at no cost. Chronic illnesses like cancer can last for several years and might require multiple treatment plans, some of which insurance might not cover.
The thought of receiving a brand new treatment is unnerving for some people, but these trials are safe. The trained research teams leading the studies provide specialized support and advice throughout a clinical trial. In addition, the participants are closely monitored and undergo frequent check-ups.
While participating in a trial, participants often form a better understanding of their medical condition. People coping with health problems tend to find renewed hope for treatment options or recovery, which leads to a better quality of life.
Participants can also take pride in knowing that they’re making a difference for everyone with similar health conditions. Often, clinical trial findings lead us to new medications (with fewer side effects) and even cures.
Without volunteer diversity, the results of clinical trials will be less accurate. A participant's genetic background may cause them to react differently to trial treatments compared to other segments of the population.
As it stands, most of the volunteers for major clinical trials are white, according to a 2021 JAMA study.¹ The study found that nearly 78% of all participants in vaccine trials from the past nine years were white individuals.
In 2018, registered clinical vaccine trial participants featured 76.% White participants; 18.5% Hispanic or Latino; 13.9% Black or African American; 5.9% Asian; 1.3% American Indian or Alaska Native; 0.2% Hawaiian or Pacific Islander; and 2.8% participants with more than one race.
So, a high number of trials failed to provide significant representation for American Indians, Alaskan Natives, Pacific Islanders, or Hawaiians. In addition, less than 2% of these studies focused on non-white races.
The study also found that women are overrepresented in clinical trials and participants over 65 are underrepresented, which goes against FDA recommendations.
According to ScienceDirect², research shows that heart disease and cancer treatments have different outcomes among people of different races. As a result, minority groups don't benefit from clinical trials nearly as much as white participants. Subsequently, they may miss out on life-saving treatments and preventatives like vaccines.
A lack of older participants in clinical trials can also skew research findings on age-related diseases like Alzheimer's and certain cancers. For example, one ACS journal³ reports that only 24% of adults over 70 years old participated in FDA-registered cancer treatment trials.
Many potential participants will avoid clinical trials due to the assumption that it will cost money. Additionally, people might worry about the financial impact of taking time off from work, finding childcare, or traveling to a clinical trial. ASCO⁴ research finds that affluent people are more likely to enroll in clinical trials. One study showed that over half of the patients couldn't find a local treatment center that hosted clinical trials.
Additionally, participants sign up for clinical trials through government or pharmacy websites. Unfortunately, not everyone owns a smartphone or computer. Even potential volunteers who are tech-savvy can get left out due to poor internet speed or a lack of tools, such as a working webcam.
There is ample room to improve participant diversity in clinical trials. Clinical trial teams are working to streamline the participation process by:
Clarifying the definition of routine care costs and what is covered by the treatment team
Offering resources for insurance reimbursement in the case of extra fees
Providing at-home examinations whenever possible
Teaching participants to use online patient portals
Providing transportation to the clinical trial site when possible
There also needs to be better education about clinical trials and more readily available reading materials. Resources should include data about:
Requirements for the participants
The length of the trial
The trial's location and commuting options
How the new treatment works
Any risks associated with the proposed treatments
To conduct fair and effective research that helps as many people as possible, the diversity of clinical trial participants must improve. In addition, clinicians need to be proactive about communicating the safety of clinical trials for minorities.
If a person observes that their race is underrepresented in trial research, they may be nervous about the side effects of new treatments. These potential volunteers will need to feel assured that their safety is a top priority and that their questions will be addressed.
Breaking down these barriers will lead to better clinical trial results and more effective treatments. If you'd like to participate in a trial near you, we can help you find those you're eligible for.