Research + Representation: Why Clinical Trials Need More Diverse Participation
If you’ve watched The Human Trial, you may have some questions about research trials, like the one documented in the film. Clinical trials are critical to making a medical product or treatment— like the therapy billed as a functional cure for type 1 diabetes—available to the public.
Trials are a key stepping stone to getting drugs, vaccines and devices approved. They demonstrate a treatment’s efficacy and safety.
However, when clinical trials don’t utilize diverse participant pools, researchers risk losing out on key insights. The research community should prioritize their responsibility to the public by studying diverse participants that accurately reflect the population these drugs and products are meant to help.
Clinical trial participation
Clinical trials rely on volunteer participants. There is never a cost to join and it is always completely voluntary. It is a participant’s right to withdraw from trials at any point.
Despite recruiting from the public, clinical trials aren’t always easy to find or access. This opaque process means many people aren’t aware that trials are happening or that they can participate.
Despite improved recruitment methods, it’s still hard to recruit participants. In fact, slow enrollment is a major cause for trials to be delayed—80 percent of clinical trials fail to meet their enrollment timeline. The most basic consequence of this is that it slows down the research and stalls new products from getting to the public.
Often times individuals are referred to clinical trials by their doctors. This is more likely to happen if their provider is affiliated with a research institution or is based in a city that has one nearby.
However, some doctors may not have the ability to stay up to date on the clinical research happening in their field, or they may lack the time needed to talk to a patient about the nuances of a trial during an office visit.
Research shows physicians are less likely to discuss clinical trials with patients of minority backgrounds.
Your ability to participate in a research trial may also depend on the time it takes you to commute to the trial site, whether it requires time away from work or if you need to arrange childcare. These obstacles are a major reason why eligibility individuals often decline to participate.
These are just some of the reasons participation in trials has been disproportionately white. Because of the numerous barriers to participating in trials, geographic and socioeconomic diversity is also lacking.
Why this is a problem for the science
For decades, trial participation wasn’t widely scrutinized and drug safety and efficacy data provided to the public—and the research behind it—was assumed to be representative of the general population.
Women and people from minority groups are widely underrepresented in clinical research, despite the fact that research shows no difference in individuals’ willingness to enroll based on their racial or ethnic background.
This matters because diseases can present differently depending on a person’s genetic background or overall health circumstances. It’s been well established in recent decades that social and structural forces greatly impact a person’s health and health outcomes.
This is why it’s a problem when trial participants aren’t representative of the racial, ethnic and socioeconomic diversity of the general population. Without stronger clinical research, society misses out on information about a drug or product’s safety and efficacy that may inform medical decisions you make for yourself, your child, or your patient.
Diabetes care is impacted by a lack of representation in the research
You can even look to standard guidelines on diabetes management to see the consequences of gaps in clinical research.
American guidelines on A1c, a common lab test used to measure blood glucose levels over time, may be less accurate for some people of color. That’s because these guidelines were established in the 1980s based on research looking at white men.
In reality, not everyone’s result from a standard A1c test means the same thing due to variations in the types of proteins some people have in their blood. Original research didn’t account for this.
For some individuals of African, South and Southeast Asian and Mediterranean ancestry, this “gold-standard” test may lead you and your healthcare team to believe your blood sugar levels are higher or lower than they really are.
Equipped with this knowledge, physicians are able to use alternative health data, like a different A1c test, to guide a patient’s diabetes management when appropriate.
Changing the status quo of research
The research community is learning from its mistakes. Despite slowing down trial enrollment, the COVID-19 pandemic has also created opportunities for implementing new ways of running trials.
Many people have adapted to seeing their doctors over video calls and using devices and apps to manage various aspects of health. Researchers have started to do the same with clinical trial research.
Researchers and pharmaceutical companies are finally using these virtual healthcare practices to decentralize trials, instead of requiring that everything be conducted at a specific site, like a research hospital. This offers more opportunities for diverse participants to be involved.
Now, clinicians may go out into their communities to meet with participants or provide participants with an app or wearable health device instead of a paper diary to track symptoms or other relevant information. And since researchers aren’t limited to collecting data when participants visit them on-site, they can collect data more often.
Virtual healthcare standards can help trial enrollment and retention
What are the benefits of this? Not only is it harder to lose an app than a paper diary, but it also reduces barriers to participation. If you can meet with your care team over video and transmit health data from a device, keeping your appointments may be easier.
This alleviates the time and financial burden that prevents some individuals from enrolling in trials due to geographic distance or other factors that make it inconvenient. It may even reduce the rate of participant dropout.
Knowing the obstacles participants face in enrolling in research trials as well as the clear consequences of unrepresentative research will hopefully continue to move the needle on making trials more diverse and accessible.
Why participate in a clinical trial?
It’s a personal decision to participate in clinical research. It may offer benefits, like having early access to a new drug, product, or treatment. The idea of contributing to the advancement of science may also be a motivation.
In fact, many trials recruit participants without underlying conditions, in addition to the target patient population. This is another way researchers can get information on how their drug or product works and is tolerated.
Today’s researchers hope by implementing these new virtual standards of care, they can not only conduct clinical trials more quickly but improve their accessibility and diversity.
You can find more information about how to find and enroll in research trials here: https://beyondtype1.org/all-about-clinical-trials/
