Investigating how to innovate mental health clinical trials
At Wellcome, we’re exploring innovative approaches to support recruitment and retention in mental health clinical trials.
We’re looking for a supplier to help us scope out what we might do in this space — this blog post explains why.
Image by Nick Turner on Unsplash.
Recruitment and retention in mental health
Clinical trials are essential for developing new, safe, and effective tools in healthcare. However, finding eligible participants and keeping them engaged throughout a trial is hard.
At Wellcome, we’re working to build a world where no one is held back by mental health problems. Clinical trials are critical for finding new ways to intervene, but challenges with recruitment and retention in mental health trials remain a significant blocker.
In mental health clinical trials, recruitment is slow and inadequate. For example, around half of all trials funded by two large UK funding agencies between 2002 and 2008 needed an extension to recruit enough participants. But the challenge goes beyond finding enough people to take part; it’s also difficult to recruit diverse and representative participants. A review of clinical trials for depression over a 36-year period (1981 to 2016) found that demographic information on race, for example, wasn’t even reported in many trials. That means we don’t know how representative those trials are of broad populations.
Once participants are recruited, retention becomes an issue. Many mental health clinical trials struggle to keep their participants engaged, and so they suffer from high drop-out rates. For example, a review of schizophrenia drug trials found an average dropout rate of 66%.
Challenges recruiting and retaining participants in mental health clinical trials lead to many problems. Not enough people engaging in trials leads to underpowered results. This means we cannot be sure that the intervention tested works as effectively as it seems. Furthermore, the lack of diversity in participant samples makes the results less generalisable. Less generalisable results mean that we don’t know if the intervention tested will work in the specific patient populations who need it. Ultimately, these challenges delay (and even prevent) safe and effective mental health interventions reaching those who need them.
Innovative (digital) tools
We need to innovate. We need better ways to recruit diverse participants into trials, and we need participant-centred methods to keep people motivated and engaged. Digital tools have potential here for a few reasons.
First, digital tools make it easier for some participants to access trials. Not everyone can attend in-person trial visits, not least because many participants live far away from trial centres. Digital tools allow participants to take part in trials no matter where they are. For example, researchers can use videoconference software to engage with participants remotely.
Second, digital tools offer more ways to tailor to participants’ needs. Trial designs often fail to account for the lived experiences of those with mental health conditions. For example, some symptoms of mental health conditions, such as low mood and low motivation, might limit patients’ ability to regularly engage with trial activities. Digital platforms like Nuvoteq lower the burden of participating in a trial by allowing participants to report symptoms and other trial outcomes from home.
Third, digital tools open the door to using AI to boost recruitment and retention rates. For example, Cogstack, a natural language processing model that analyses patients’ electronic records, reduced the need for manual screening of potentially eligible participants by 85%. For another example, machine learning algorithms were used in the mMitra programme to identify participants at risk of disengaging from a free maternal health service call. Researchers allocated resources to keep at-risk participants engaged, successfully reducing the number of dropouts by 32%.
The bottom line here is that we think digital tools could enable more efficient and participant-centred clinical trials.
Trustworthy tools
It’s not enough for a digital (or other) tool to be effective, it also needs to be trustworthy. These tools need to handle sensitive participant data securely and they need safeguarding measures in place to protect participant safety.
We must also ensure that these tools are as beneficial as possible for communities with limited access to or experience with digital technologies, for example, the elderly, or people living in rural or low-resource settings.
Finally, we must work with trial participants and broader communities to tailor recruitment and retention tools so that they support positive experiences for people involved in clinical trials.
Next steps
We’re starting by commissioning landscaping research to explore the current state of the art, and where there are opportunities for more effective, safe, and inclusive solutions in the space.
Check out our request for proposals for further information on the landscaping research. The deadline to submit an expression of interest and questions on the work is the 25th of March, 2024. The deadline for submitting the full proposal is the 22nd of April, 2024.
