When the cold regulations and requirements of clinical trials meet the overheating elements of human behaviour, the mists of confusion and misunderstanding often prevail.
They form a recruitment and retention weather front with a negative forecast on research schedules and budgets – lifting the fog is a pharma mission for the ages.
The principle of trial enrolment received a welcome boost during COVID-19 when the public benefit of testing vaccines drew global attention and approval. Efforts are continuing to build on that base, with the UK government pouring £400m into programmes supporting clinical research.
The aim is to make it easier to conduct clinical trials and, critically, much more attractive to patients to enrol and stay enrolled when human behaviour and the impact of everyday pressures creates barriers.
The European Clinical Research Infrastructure Network (ECRIN) has framed its meeting in Madrid on 20 May – International Clinical Trials Day – with the tag line: ‘How do we progress from discussion to action in ensuring the appropriate populations are taken into account in the design of a clinical study?’
All in-person places for the congress have been taken and its patient engagement module on the complexities of communicating with patients from culturally diverse backgrounds and sharing best practice is in high demand.
The energy and intent to create a more welcoming and effective clinical trials climate for patients is there but the obstacles remain significant. Enrolment resistance is still a strain of human behaviour that can remain immune to persuasion while triggering ruinously high drop-out rates.
“There is a clear sense that we are not getting the best from clinical trials in terms of serving the patients who enrol in them as well as the pharmaceutical industry’s ambition for them. I don’t think it is catastrophic because we are doing some things well but there is definitely room for improvement,” says Rob Horne, Professor of Behavioural Medicine at the School of Pharmacy, University College London, a world-leading expert who has spent 30 years researching psychological and behavioural factors in treatment adherence.
“Many clinical trials experience delays due to slow recruitment and retention is also a challenge, with drop-out rates of 20% not being atypical. Both are hugely costly. It is essential to get the best value from clinical trials and it is clear that there are opportunities to enhance both recruitment and retention by addressing human behaviour.”
Increasing participation rates
Professor Horne has developed internationally recognised frameworks and tools to support patient engagement and adherence and believes these principles can be applied to improve clinical trials efficiency and efficacy. He also founded the consultancy Personia Health, in partnership with University College London, which applies his proven tools and techniques to support patient engagement and improve health outcomes.
“By applying what we’ve learned from 30 years’ worth of global research across all diseases in understanding the barriers to engaging with treatment, we can start to improve the way in which we communicate and support people, and start to increase participation rates,” he says.
“At the core of this is an understanding of how we work as humans and how we respond to advice. There are many reasons why someone might refuse the opportunity to engage in a trial or drop out early but they boil down to two fundamental issues: ‘can’t’ and ‘don’t want to’. Most efforts to improve engagement focus on providing good information and making it easier for patients to participate. This is helpful but we can do more if we take into account the perceptions as well as practicalities of participation.
“Patients do not come as blank sheets that you can write instructions on – they have pre-existing beliefs about clinical trials and medicines. These can lead them to conclude that taking part is not a good idea for them. By understanding those, you can change the way a trial is presented and discussed, and offer better quality support and information to help patients make informed choices – help them not refuse to take part in a trial or drop out for the wrong reason.”
Read the article in full here.