Diversity in clinical trials is vital to ensure treatments are safe for everyone. Clinical trial participants come from all backgrounds, including different sexes, races, and ages.
Including diverse populations in clinical research ensures that the treatment being tested will be effective. Ethnicity and other factors can affect how well a medication works or how quickly a treatment produces results.
Other reasons diversity matters in clinical trials include:
Diversity in clinical trials also addresses a recent push from the U.S. Food and Drug Administration (FDA). It seeks to run studies that reflect the country’s population. When presenting a new drug, for example, the FDA used to require a “Race and Ethnicity Diversity Plan.” This plan is necessary early in the medication’s development process. There are questions about whether this requirement will still apply after a recent court order. The reasons behind the FDA recommendations are still relevant, however. The FDA expects to see the enrollment of underrepresented populations in clinical studies.
Inherent barriers may prevent some patient populations from participating in clinical trials:
Eligibility criteria could also prevent minority groups from participating. Often, clinical trials require that participants have no comorbidities. This could rule out many willing people. Hispanic and African American communities, for example, tend to experience higher instances of chronic diseases like diabetes. In a study for kidney disease, for example, an additional medical condition could exclude them from studies.
Mobile clinics, such as Mobile Vision Clinics, offer more people the opportunity to participate in clinical trials.
Additionally, mobile clinics can help support community health services. This helps build trust and address inequities while also providing information about clinical studies.
Traditional trial sites are often located in higher-resourced or urban areas, which can be harder to reach for people facing transportation or financial barriers. Mobile clinics make it easier to include participants from a wider range of communities, including those in rural areas or experiencing unstable housing or frequent moves.
They can also offer services in familiar locations, like community centers, attracting people who may not have otherwise considered participating.
With mobile clinics, it’s easier to schedule visits around participants’ work and family responsibilities, opening the door for people who might otherwise assume they can’t take part.
When staff are trained to work effectively with participants from different backgrounds, they can better support patients, address cultural considerations, and build trust—helping trials feel more accessible, respectful, and reflective of the communities they’re designed to serve.
Mobile clinics reduce patient burden, resulting in patients staying in trials longer. Underrepresented groups can struggle to participate in long clinical trials due to the financial and logistical challenges they can pose. By making these initiatives easy to access, retention improves.
Increasing diversity has long been a focus of the FDA in drug trials and other clinical studies. The Consolidated Appropriations Act of 2023 began to require sponsors of trials to submit detailed Diversity Action Plans. Typically, these plans are necessary during phase 3 trials and specific medical device investigations.
The FDA is seeking greater enrollment of subgroups, including Hispanic, African American/Black, and Asian communities, across the country.
By presenting Diversity Action Plans during the trial's development, it’s easier to decide on the best locations for the trial. Many other details can be addressed early on that could encourage community engagement from underrepresented groups.
Convenience-enhancing options, such as mobile clinics, are one way to address what the FDA is now focused on.
A lack of diversity in clinical trials can make it harder to develop treatments that work for everyone, putting untested demographics at risk of side effects and potentially leading to worse health outcomes.
Getting stronger metrics on how interventions impact diverse groups of people makes medical research safer for everyone.
At 20/20 Onsite, we offer mobile clinical trial services that help reduce health disparities by making participation easier for everyone. Our certified clinical staff and our standardized workflow make it easier to collect high-quality data while offering all the clinical trial resources you need.
Because our services are focused on patients, we provide the point-of-need support that can make retention easier. In fact, our clinical trial solutions have been shown to increase patient retention from 70% to 91%. We do this by providing point-of-need care that is convenient, quick, streamlined, and patient-centric.
If you’re at the planning stages of clinical research, increasing patient diversity can be much easier with help from 20/20 Onsite.
How can we help? We can bring your studies right to your point of need through our mobile trial services. If your research is in jeopardy due to FDA mandates, we also offer clinical trial rescue services to help you navigate any delays.
We’re ready to assist you in finding the right point-of-need deployment option for any of your upcoming studies. With a virtual tour, you can get a better sense of how we can help.
Schedule a consultation with the team at 20/20 Onsite.