By Cara Brant, CEO of Clinical Trial Media
It’s widely accepted that clinical trial participants should mirror the populations of people who will eventually use the treatments–and reflect the population at large–but achieving this is easier said than done.
Making sure that under-represented demographics are represented is a challenge that starts early in recruitment and continues through the lifetime of a trial.
For instance, women make up 60 per cent of the patient population when it comes to mental health diseases, and therefore treatments, but only account for 42 per cent of trial participants.
Meanwhile, Hispanics make up 19 per cent of the US population, but only 11 per cent of clinical trial participants.
Achieving higher diversity with only a site’s database is challenging, though, given heightened competition for similar participant pools.
In 2018, for instance, there were 260,000 trials. By 2024 there were nearly double that figure. As a result, trials need to target and reach new audiences to achieve their enrollment goals.
Once enrolled, it’s necessary to keep participants engaged for the duration of the trial.
On average, 30 per cent of trial participants drop out mid-process, which results in heavy financial costs and delays, in addition to affecting study results.
For years, pharmaceutical companies have been on the hunt for effective ways to better match patients with applicable trials.
Here is how combining human expertise with technological solutions is enabling clinical trials to overcome this challenge and more effectively recruit and retain participants.
Attract more diverse participants by diversifying communications–at scale.
One of the key roadblocks to participant recruitment is a lack of awareness about available trials and how to get involved.
Regardless of age, ethnicity, gender, race or other demographics, people have made it clear that they want to learn about trials that can help them or their loved ones.
This means that trial sponsors need to take extra steps to ensure their messages are reaching and resonating with people regardless of their baseline knowledge about clinical trials.
Digital advertising is key to participant identification and recruitment, since it allows sponsors to reach potential participant populations by meeting them where they already spend time.
Cara Brant
These advertisements should be delivered in the target population’s first language and account for nuances across geographic locations, varying health conditions and knowledge levels.
This can mean multiple variations of a single ad.
On a small scale, this can be handled by humans but achieving precision messaging at scale–often on a tight timeline–requires automated technology.
Take, for example, the process of recruiting for a trial for Alzheimer’s, which is most prominent among Black and Hispanic women.
Trial sites should be set up in an area with a high density of the populations the trial is looking to recruit. Then, use hyper-targeted media buying to help tailor messaging to people in those locations.
By tapping technology to aid in targeted potential participant outreach, trials can expand their participant pools and prescreen more people to effectively match them into trials where they qualify, when the time is right.
As a result, trials can overcome their challenges of recruiting for similar participant pools.
Keep participants enrolled by keeping them engaged the old-fashioned way: human connection.
While technology can drive participant outreach through hyper-targeted media buying, it cannot replace the empathy, compassion and cultural sensitivities that human connection offers to patients during times of vulnerability.
It’s the foundation of relationships and the key to participant retention.
By nature, healthcare is very personal and intimate. Some people may have a diagnosis they do not fully understand or treatment plans that leave them confused or anxious.
This is one area technology falls short and where well-trained human nurses and clinicians step in.
From initial contact, nurses and clinicians are able to step in and answer any questions and keep participants at ease.
This combined with having nurses on staff that speak the native language of participants the trial is looking to recruit, helps retain diverse populations.
For example, when looking to recruit and retain people for an Alzheimer’s trial in the U.S., it’s important to have Spanish speaking nurses on staff in an area with a large Spanish speaking population.
The likelihood of participants staying enrolled through trial completion increases when participants are able to understand the trial requirements and expectations while asking questions in their first language.
AI-human partnership achieves heightened diversity in trials.
Leveraging these tactics in a vacuum will not increase diversity in trials – that comes down to demonstrating a genuine commitment to recruiting and retaining diverse participants.
By combining AI driven efficiency with human touch, the industry is seeing significant breakthroughs in increasing clinical trial diversity.
For example, we’ve achieved up to 62 per cent of participant randomization from diverse populations in a trial for Alzheimer’s Disease, which is notoriously difficult to recruit for.
We’ve also achieved 63 per cent female randomizations– 38 per cent of which were from diverse populations for an alopecia trial that’s more prominent in females.
Similarly, 59 per cent of randomizations for an immunology trial in Hidradenitis Suppurativa (HS) – a condition most prevalent among Black women – were from diverse populations.
The approach has helped sponsors achieve their diversity goals – ultimately getting drugs into the hands of people who need them, faster.
While technology will undoubtedly continue to evolve, long-term engagement and genuine connection will continue to stem from real human-to-human interaction for the foreseeable future.
There is no substitute for a gentle demeanor or an empathetic gesture when patients might be uncertain, frustrated, or even frightened.
Recruiting and retaining diverse populations is hard – but today the tools exist to make it easier.
Now that the industry is aligned on the need for treatments to be tested on populations who will use them in the wider market, it is up to clinical trial sponsors to use these tools to their advantage and drive change.
