Improving engagement with clinical trials: time to apply behavioural science

Many clinical trials struggle to meet their recruitment targets on time or experience high attrition rates, jeopardising the scientific validity, timelines and financial feasibility of drug development programmes. Moreover, there is concern that engagement with clinical trials may be lower in particular communities. This creates a further challenge of ensuring appropriate representation across cultural, religious and sociodemographic groups.

The many reasons why someone might refuse the opportunity to engage in a trial or drop out early can be summarised as: ‘can’t’ and ‘don’t want to’. This sounds entirely obvious but failure to translate this insight into more innovative patient support contributes to the engagement gap in clinical trials. Like most human behaviour, engagement in a clinical trial is a product of motivation and ability. We are influenced by others and by our environment, but if we think it’s a bad idea to take part and/or find it difficult to do so, we are unlikely to start or continue to participate.

The need for an understanding of patients’ experiences of trials has led to the development of innovative digital technologies to reduce patient burden, improve patient experience and make it easier to participate in trials. Recent advances in behavioural science create an opportunity to build on these developments by enhancing patient motivation to engage with trials. Pharma companies put a lot of effort into making sure that patients receive comprehensive information about the trial. This is essential but may not be enough, because we have an information-action gap in terms of engagement.

We have developed the Necessity Concerns Framework (NCF) to explain the psychological processes influencing engagement with medicines and trials and to develop more effective messaging that bridges the information-action gap. This disease and treatment agnostic framework has been validated in global research across diseases, countries and healthcare systems, and is applied in the NICE guidelines for involving patients in decisions about medicines and supporting adherence.

Patients do not come as blank sheets that we can write the instructions on. They have pre-existing beliefs about clinical trials and treatments that influence how they interpret the information they are given. Necessity beliefs are the foundation. They can be thought of as the answers to two key questions we ask ourselves when we are deciding whether to follow a recommended course of action, such as participating in a trial or taking a treatment: ‘How much do I really need to engage with this trial/treatment to achieve a goal that is important to me’ and ‘Can I get way without doing it?’ The decision to participate will be determined by how we judge our personal necessity relative to our concerns.

Patient thinking around clinical trials is nuanced: ‘How important is it for me, right now, to start and continue with this trial?’ and ‘What are the downsides?’; ‘What are my concerns about doing this (taking this treatment, undergoing tests, completing assessments, etc)?’; ‘Can I trust the system or am I being used as a guinea pig?’ and ‘Are there practical difficulties to my starting and continuing?’ Not participating in the trial can seem to be the common-sense option to the patient. The problem is that, although these beliefs seem logical to the patient, they are often based on misconceptions and erroneous beliefs about the treatment and the trial.

To optimise engagement with treatment and recruitment and retention in trials, patient communication and support needs to achieve three things:

1. Convince patients that participation is necessary to achieve a goal that’s important to them
2. Uncover and address their concerns
3. Make participation as easy and convenient as possible.

Rob Horne is UCL Professor of Behavioural Medicine and Founding Director of Personia Health, a UCL Business company