Alzheimer’s Trials and Others See More Diversity When Technology and Humans Work Together

Clinical trial sponsors are facing mounting pressure to secure trial participants that more closely reflect the diverse populations affected by their treatments, but are still struggling to do so. This isn’t an issue that only affects some pharmaceutical companies or that’s only present when trialing some health conditions.

At the very highest level, trials simply don’t reflect populations as a whole. For instance, in the U.S., Hispanic or Latino people make up 19% of the population, but only 11% of clinical trial participants in 2020 were Hispanic or Latino.

On a more micro-level, we can look at trials for specific health conditions, such as Alzheimer’s Disease, which is most prevalent among Black and Hispanic or Latino women. Its trial populations should reflect the demographics that are most likely to have the disease and benefit from the treatment, but this has not been the case in many past trials.

All of this is now changing.

Recently, we’ve seen first-hand how a machine learning-aided approach to participant identification and targeting can lead to significant breakthroughs in diversity efforts across active Alzheimer’s Disease, Cardiometabolic and Immunology trials. Equipped with this type of advanced technology, recruitment professionals are able to synthesize millions of proprietary and public data points to more acutely target trial candidates–and do so at a scale that’s not possible manually.

But it’s important to note that technology alone is not enough to keep trial participants engaged through the duration of trials. That requires a human touch.

Here are a number of other on-the-ground insights on the challenges and advancements in recruiting diverse populations for trials.

The lack of diversity in trials isn’t due to a lack of desire on behalf of sponsors, nor a lack of interest among diverse populations to participate.

Rather, it’s that many people don’t know how to participate, don’t know which trials are available to them, how to qualify or otherwise get involved. This means clinical trial recruitment efforts can’t operate as though all potential participants have the same baseline knowledge. That assumption alone has contributed greatly to the lack of efficacy in reaching these populations.

Getting in front of new audiences requires a lot more than simply scaling your existing efforts.

Now that we know that one of the major obstacles to recruiting is informing and educating different populations about trials and how to get involved, our next move is figuring out how to get in front of these new audiences.

It’s important to note that these audiences are spread across a number of geographic locations, each with different health conditions and varying levels of knowledge about trials, so we need to meet them where they are. Scaling this type of participant identification effort with precision is a job for technology. 

Sponsors can leverage AI and machine-driven platforms to hyper-target media buying efforts and reach and educate different groups about clinical trials at scale. Geo-specific advertising can help find relevant people in the desired physical locations. From there, they should consider tailoring their messages specifically to the people they’re attempting to recruit in those locations. For example, sponsors might want to consider adding a Spanish language component for each U.S. campaign to ensure they can reach the highest number of potential Spanish-speaking participants. Additionally, Spanish-speaking nurses on staff can help put potential participants at ease by communicating in the language they are most comfortable with.

In addition to first language, race and location, sponsors should also account for variables such as age, gender and others.

New audiences will participate if they understand the value of doing so.

All of this is to say sponsors can’t only identify and inform new populations about trials; they need to work to understand their specific needs and clearly communicate the value of clinical trials.

Using this approach, the industry is seeing significant breakthroughs in achieving diversity in clinical trials. For example, some results we’ve seen include:

• 62% of participant randomizations in a trial for Alzheimer’s Disease–most prevalent among Black and Hispanic women–were from diverse populations.
• 32% of randomizations for a cardiometabolic program, testing a treatment for conditions that most prominently affect American Indians, Alaskan Natives, Black and Hispanic populations, came from diverse populations.
• For an immunology trial in Hidradenitis Suppurativa (HS) –most prevalent among Black women – 59% of randomizations originated from diverse populations.

Recruiting new diverse audiences is step one. Ensuring that they (and other participants) stay in the trial for the full duration is step two.

The primary reason for delays in clinical trials continues to be patient recruitment and retention. But it’s clear boosting a participant’s satisfaction with their clinical trial experience is the best method to increase retention.

Through extensive patient surveys, trial sites can better understand how patients are feeling throughout the trial, as well as during their experience at sites. Participants often express appreciation for appointment reminders that keep them on track. They also respond positively to efforts that help them understand their role in a study and reinforce their importance throughout the process. This can look like a mix of texts, emails and phone calls that deliver appointment reminders alongside “what to expect”-type guidance and messages of motivation and appreciation. Simply thanking participants for their ongoing commitment to trials and keeping them engaged throughout the process helps participants better understand their importance to the trial. And this directly translates to increased retention.

Trial sites have also seen positive feedback and higher retention when pairing patient populations who are vulnerable or would benefit from additional support with a nurse advocate. This is particularly effective when the nurse advocate speaks the participant’s first language. This is an important factor when it comes to boosting retention for historically underrepresented populations in trials. A nurse advocates co-travels with each patient throughout their clinical trial journey to ensure continued patient engagement and the best possible patient experience.

Take special steps to retain women who are participating in trials.

No matter what their demographic, optimizing trials for women’s participation means considering nuances of their lifestyle, not just during recruitment but in the design of the clinical trial itself.

Today, most women have their hands full, working full time jobs in addition to taking care of family and a household. As a result, the thought of adding another obligation into a jam-packed routine while coordinating existing responsibilities, such as childcare, may turn some women away from participating.

Flexibility is key for trials that want to effectively recruit and retain women. This includes designing trials with telehealth check-ins to reduce travel, extending evening or weekend hours for those with full time jobs and introducing flexible appointment booking options. We’ve also received positive feedback from trial sites that provide child entertainment in the form of books or puzzles in the site waiting room.

A trial site’s ability to seamlessly integrate into a potential participant’s established routine will ultimately be what allows trials to recruit and retain women–and in turn, speed up more treatment approvals for women.

Recent government action to help boost trial diversity reinforces the industry’s urgency.

In June the FDA released a new draft guidance on Diversity Action Plans to boost diversity in clinical trials. This aims to increase clinical trial study enrollment for underrepresented populations so treatments can be tested on a proportionate population of those most likely to use them.

This move further demonstrates that the government and industry are aligned on the need for diversity in trials, but now the onus is on clinical trial sponsors to effectively reach, recruit and retain these populations. 

Unlike in the past, the industry now has the tools it needs to achieve diversity in clinical trials.

Once all clinical trial sponsors optimize their participant recruitment and retention efforts, trial populations will look a lot more similar to the populations that use the treatment in the wider market. This reality will become the industry standard, not the anomaly.

The main difference between the past and the future is that the industry now has the tools and government alignment it needs to achieve new levels of diversity in clinical trials.