Tackling the recruitment crisis in clinical trials

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

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

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

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

Inability to reach key communities

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

Fundamentally, the lack of diversity in trial recruitment needs to be addressed. Many argue that health care has a blind spot when it comes to reaching marginalized groups, resulting in low awareness among these communities that trials are even underway. However, this reasoning is only credible up to a point, especially when it comes to patients who are already in regular contact with a healthcare professional. A person with type 1 diabetes, for example, will already be in (at least) semi-regular contact with a clinician, who should ask the patient about their participation in future trials.

More important is the problem of declining confidence in the wider medical industry. There is well-documented evidence of above-average levels of skepticism towards the pharmaceutical industry from ethnic minorities, immigrants and members of LGBTIQA+ communities, suggesting that clinical trials are not not intended for “people like me”.

The remedy will not be as simple as “reaching out” to the affected community. Rather, it is about seeking to understand the complex concerns and motivations of those involved, as individuals. This requires the same level of personalized understanding that FMCG brands aspire to achieve, which taps into the personalities and mindsets of their users. To date, such factors are not taken into account by medical professionals, since they are not visible to them. They are limited to self-report techniques and focus groups, which are unreliable for uncovering people’s true motivations. This problem must be overcome for progress to be made.

Unclear communication of value

Another important factor is how the value of trial participation is communicated to potential participants. Traditionally, pharmaceutical companies have tended to prioritize monetary incentives when reaching out to trial candidates, assuming reimbursement is the primary driver. Interestingly, however, there is little evidence to suggest that offering more money leads to better recruitment.

That’s not to say paying attendees aren’t crucial. People need to be reimbursed for their time in order to make trials financially accessible to everyone. However, it is important to note that the inducement through the rational and impersonal exchange of money does not take into consideration more emotional factors, such as an individual’s personal context and a human need for connection, which may be much more powerful motivators.

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

Build a relationship

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

The experience of pharmaceutical companies during the pandemic further illuminates 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, it was expected that this would result in increased participation and easier recruitment. However, this is not the case.

Even anecdotally, it teaches a clear lesson: people crave human touch and emotional connection. During the remote trials, participants were unable to meet others going through the same experience, or speak 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 enormous meaning from their role. The feeling of “giving something back” to those suffering from a similar health condition is extremely motivating for people and should not be underestimated. Perhaps reducing friction unintentionally reduces meaning for potential participants.

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

How to facilitate change

So how can the industry begin to seize some of these opportunities to drive clinical trial adoption?

A critical starting point is finding ways to bring people together and unite communities around a common goal. JDRF is a non-profit organization that funds type 1 diabetes research. It’s a great example of how a charity can create a sense of community around diabetes patients and their families. It regularly brings people together through events and fundraisers, providing opportunities for awareness and interest in relevant trials. Such gatherings can be seen as opportunities to connect with the diversity of voices and interests that the charitable sector represents. The challenge then is to capture, respect and act on this knowledge. Big companies, like Johnson & Johnson and Pfizer, are already doing it, and more will soon follow.

The business case for change

In the end, patients, like everyone else, are predictably irrational. While scientific and evidence-based understanding of human behavior is essential to driving lasting behavior change, the fact is that people do not make decisions based on rational information alone. Therefore, any design or recruitment must consider both rational and emotional arguments.

Embracing a change, no matter how small, can be easier said than done, especially in large organizations that have been trialing a certain way for a long time. This is where an outsider’s perspective is invaluable.

To address the pressing trial recruitment crisis, the industry needs to re-evaluate how it designs trials. It should start from first principles, in terms of understanding and valuing participation and participants. It is recognized that change needs to happen and there is a business case for making that change. Adopting a new perspective can help the industry achieve this.

About Margie Peters

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