Clinical Trials are Getting More Diverse Thanks to AI—and Humans

Applied Clinical Trials Online

It’s widely agreed that clinical trial participants should reflect the populations of people who will ultimately be affected by the resulting treatments. For instance, there’s no debate that since Hidradenitis Suppurativa (HS) is a condition most prominent among Black women, that trial populations for HS treatments should be proportionately populated by this demographic. But achieving this is a challenge that continues to confound the industry.

The Boston University School of Medicine recently found that efforts to boost diversity for some trials continue to fall short. While clinical trial sponsors are eager to find solutions, they still struggle to populate trials with participants that more closely reflect real-world patient populations. The federal government has acknowledged the problem, too. In the past year alone, it has taken notable steps to boost clinical trial diversity in the US through Diversity Action Plans.

The good news is that, with the help of emerging technologies, advancements in AI and the application of machine learning to trial data, we’re starting to see a positive shift towards diverse participant recruitment. Retaining these populations for the entire trial is another challenge, though—and one that requires human touch to overcome.

Here is a look at some ways clinical trial sponsors can effectively recruit and retain diverse populations, by bringing technology and humans together.

To reach new audiences, introduce new tactics that solve known problems

One reason that trials have historically lacked participant diversity is because people don’t know how to participate or get involved. As a result, recruitment efforts should reflect the fact that different populations have different levels of knowledge, and therefore need to be educated differently about everything from the process to the benefits.

Achieving this will require sponsors to design their trial recruitment efforts to account for nuances across wide geographic locations, varying health conditions and knowledge levels. This might seem like a job that humans can handle on their own—and it is on a very small scale—but it’s a job for technology on a large scale, especially given the level of precision necessary to meet diversity goals without delays.

AI and machine learning technology can help hyper-target media buying that reaches multiple populations with different messages. For example, if you are looking to recruit for an HS trial at a specific trial site, start your search within a 25-mile radius. Then, consider tailoring messaging to people in those locations. If the community within that 25-mile radius is predominantly composed of Caribbean immigrants, consider adding a French component to the campaign. Additionally, bring on nurses who speak the same language and can help put potential participants at ease by communicating in their native tongue.

Beyond first language, race, ethnicity and location, sponsors should also account for variables such as age, gender and others. In turn, sponsors will be able to identify and recruit new populations for trials while accounting for their nuanced needs and communicating the value of clinical trials.

Design trial sites with inclusivity in mind

Where technology stops and skilled teams step in is in creating an experience with empathy, compassion and an understanding of different participants’ nuanced needs. People have different lifestyles, for instance. So, trials that require monthly in-person visits between the hours of 9-5 at one designated site will be difficult for some participants and may increase trial discontinuation rates.

Knowing that flexibility is key to effectively retaining people across demographics and that requiring visits during the workday may cause people with a full-time job to drop out, sponsors might design trials with weekend participation or extended evening hours. This will enable participants to fit the visits into their schedules and reduce repeated requests for time off or, worse, participant drop off. Alternatively, telehealth check-ins can also effectively gather necessary data with flexibility in mind.

For trials testing treatments that primarily affect women, like HS, sponsors should design trial sites to cater to a family. Women may have obligations such as childcare in addition to a full-time job, so when in-office visits are necessary, they may need to bring along their children. Trial sites that offer child entertainment in the form of books or puzzles in the waiting room often receive positive feedback from participants.

Participant retention is a direct reflection of the experience—which can’t be left to technology

Trial design is the first step to effective retention, but maintaining a high level of participant satisfaction throughout the full trial experience has proven to be the most powerful way to increase retention. To understand participant satisfaction and sentiment sponsors must measure how participants are feeling at different points in the trial.

Through surveys and direct one-to-one interactions, we know that participants commonly respond positively to appointment reminders and efforts that help them understand their role in a study. Communications can take shape as texts, emails or phone calls that offer more context around “what to expect” and messages of motivation and appreciation. Small tokens of gratitude can go a long way when communicating the importance of each participant. Reiterating that participants are playing a part in something bigger than themselves directly correlates with increased retention.

Trial sites also see increased participant satisfaction and retention when they pair vulnerable participants with nurse advocates who can support them throughout the trial process. This direct human guidance is critical to keeping many participants engaged and informed during what can be months’ long trials.

In the case of populations that might have been attracted to trials through communications in their first language, it’s important to continue the personalized experience in their first language during the actual trials. This can ensure historically underrepresented populations stay enrolled through the full trial duration.

It’s clear that the industry understands the need for diversity in trials. The difference between now and even a year ago is that now there are tools to help meet their goals. The onus is on clinical trial sponsors to effectively reach, recruit and retain these populations.