Tackling the clinical trials recruitment crisis

Why are so many clinical trials failing to meet their recruitment deadlines,
and what can be done to overcome this problem?

By Christel Wolthoorn

Using clinical trials to validate new treatments is one of the most essential, yet costly, processes within the global healthcare industry. These trials are not only expensive to run, but also notoriously time-consuming, particularly during the patient recruitment phase.

According to a white paper by One Research, over three-quarters of all clinical trials fail to meet their recruitment deadlines. In 2013, the UK House of Commons Science and Technology Committee issued an extensive report on clinical trials; it showed that frontline clinicians, whether from the research or primary care community, were not being supported with the resources they needed to reach and recruit willing patients effectively.

There is a big problem here. Why are so many trials experiencing such difficulty in meeting their recruitment deadlines?

Using clinical trials to validate new treatments is one of the most essential, yet costly, processes within the global healthcare industry. These trials are not only expensive to run, but also notoriously time-consuming, particularly during the patient recruitment phase.

Crucially, the lack of diversity in trial recruitment must be addressed. Many argue that healthcare has a blind spot when it comes to reaching marginalised groups, resulting in low awareness among these communities that trials are even happening. However, this line of reasoning is only credible up to a certain point, particularly when it comes to patients who are already in regular contact with a healthcare professional. Someone with type 1 diabetes, for example, will already be in (at least) semi-regular contact with a clinician, who should be asking the patient about participation in forthcoming trials.

More significant is the issue of declining trust in the wider medical industry. There is well-documented evidence of above-average levels of scepticism towards the pharmaceutical industry from ethnic minorities, immigrants and members of the LGBTIQA+ communities, which results in the belief that clinical trials are not for ‘people like me’.

The remedy will not be as simple as ‘reaching out’ to the relevant community. Rather, it is a case of seeking to understand the complex concerns and motives of the people involved, as individuals. This requires the same level of personalised understanding that FMCG brands aspire to achieve, which tap into the personalities and mindsets of their users. To date, factors like this are not considered by healthcare practitioners, because they aren’t visible to them. They are limited to self-report techniques and focus groups, which are unreliable for uncovering people’s true motivations. This issue must be overcome for progress to be made.

Another important factor is how well the value of taking part in trials is communicated to potential participants. Traditionally, pharmaceutical companies have tended to prioritise monetary incentives when talking to trial candidates, assuming that reimbursement is the greatest driver. Interestingly, though, there is little evidence to suggest that offering more money leads to better recruitment.

This is not to suggest that paying participants is not crucial. People need to be reimbursed for their time to make trials financially accessible to everyone. However, it is important to note that incentivisation through the rational, impersonal exchange of money does not take into consideration more emotional drivers, such as an individual’s personal context and a human need for connection, which can be much more powerful motivators.

This approach is not unusual for the healthcare industry, which, by its nature, takes a very clinical, results-driven view of the world. The challenge, therefore, is to design and communicate a recruitment process that considers both the rational and emotional cases for trial participation.

Currently, recruitment is viewed as an end-to-end process, rather than an experience. This means that the industry is missing a vital opportunity to engage potential participants using a sense of community and purpose. This is the foundation upon which a clinical trial should be built.

The experience of pharmaceutical companies during the pandemic sheds further light on this challenge. COVID-19 forced the industry to experiment with how trials were conducted, with a number testing the feasibility of running them remotely. Initially, there was an expectation that this would see increased participation and easier recruitment. However, this has not been the case.

Even anecdotally, this teaches a clear lesson: people desire human contact and an emotional connection. During remote trials, participants were unable to meet others going through the same experience, or to talk with clinicians face to face. This connection is important, not only because a trial can be a demanding process, but also because participants can derive an enormous sense of purpose from their role. The feeling of ‘giving something back’ to those who are experiencing a similar health condition is hugely motivating to people and should not be underestimated. Perhaps reducing friction unintentionally reduces the meaning for prospective participants.

Such interactions are harder emotional levers to quantify, but they are no less important than more tangible, monetary incentives. People are not wholly rational beings who are only incentivised by money. Instead, trial recruitment must take a holistic view of human motivations and focus just as closely on the sense of community and purpose that can be gained from becoming a participant. This may mean counter-intuitively adding friction and some degree of complexity, in order to help them find meaning in trials.

So how can the industry begin to act on some of these opportunities to drive clinical trial uptake?
An essential starting point is to find ways to bring people together, and for communities to convene around a shared purpose. JDRF is a non-profit organisation that funds type 1 diabetes research. It is a good example of how a charity can create a sense of community around diabetes patients and their families. It regularly brings people together via events and fundraisers, presenting opportunities to raise awareness and interest in relevant trials. Such encounters can be seen as opportunities to connect with the diversity of voices and interests that the charity sector champions. The challenge is to then capture, respect and act on this knowledge. Major companies, like Johnson & Johnson and Pfizer, are already doing this, and more will follow soon.

Ultimately, patients, like all people, are predictably irrational. While scientific, evidence-based understanding of human behaviour is crucial to driving sustainable behavioural change, the fact is that people do not make decisions based on rational information alone. Hence, any design or recruitment must consider both the rational and the emotional arguments.

Enacting change, however small, can be easier said than done, particularly in large organisations that have conducted trials in a certain way for a long time. This is where an outsider’s view is invaluable.

To tackle the pressing trial recruitment crisis, the industry needs to re-evaluate how it conceives trials. It must start from first principles, in terms of how participation and participants are understood and valued. It is recognised that change needs to happen and there is a business case for making that change. Taking a fresh perspective can help the industry get there.

References available on request.

Christel Wolthoorn is managing director of LovedBy Consulting