28-29 - CLINICAL TRIALS: Drive time

The past couple of years have raised several aspects of healthcare in the public’s consciousness and one of the leading themes has been the role of clinical trials in pharmaceutical development.

Since the COVID-19 pandemic gripped us – and scientists worked flat out to develop viable vaccines – the corresponding need for clinical trials to test the vaccines has come to the forefront. This work is ongoing as the virus mutates. Indeed, last month, it was announced that Pfizer and BioNTech had started clinical trials for a new COVID vaccine targeting the Omicron variant.

Pre-global pandemic clinical trials were rarely written or talked about in the media unless something had gone wrong. While COVID-19 vaccine trials have garnered headlines, these have taken place against a backdrop of significantly more clinical trials being conducted in general. Between 2000 and 2020, there was a 1,500% increase in yearly registered clinical trials.

This means that recruiting patients to take part in those clinical trials has become a top priority and is now one of the sector’s biggest challenges.

Drug development has become more competitive over the past couple of decades because of several factors – not least the rise in technology and the better understanding of connections between medical conditions. For example, new commonalities have been discovered between type 1 diabetes, lupus, multiple sclerosis and rheumatoid arthritis, suggesting that drugs already in use to treat one autoimmune disease could be equally beneficial for another.

But for every trial many people must be recruited – and retained for the duration of the trial – to make the evidence conclusive; to prove with as little doubt as possible that any response is, or isn’t, related to the drug.

Calculating how many patients are needed to give your data clinical relevance is a science in itself. This puts pressure on pharma companies to find the right people – sufficient to accommodate a typical dropout rate of about 19%.

As social media has grown, so too has its use as a channel for clinical trial recruitment. There are inevitable pros and cons to this method. One benefit is that it offers a direct-to-patient outreach approach meaning companies aren’t restricted to contacting prospective patients through a doctor or a specific site.

Rules to recruiting patients via social media, however, vary by country. For instance, in Spain direct approach through social media are prohibited whereas in the UK and US they are permissible. Even then, the wording must be carefully compliant – avoiding any direct benefits to taking part in the trial or overpromising outcomes.

More recently – driven by Facebook’s data privacy issues – social media platforms have added restrictions to targeting people based on key criteria and their recruitment role has been less effective.

This has led to industry relying more heavily on large databases of ‘opted-in’ patients or healthcare professionals to recruit for trials. Companies such as Antidote and StudyKiK, have established themselves as businesses that help people learn about clinical trials and opt in if they are interested. Companies can now go to these databases knowing they contain a repository of pre-qualified contacts.

These businesses have changed the landscape for recruiting people for clinical trials and we may reach a point where companies can rely solely on them for filling trials. At present, it’s more likely that a database of this sort will form one of several channels.
When devising a strategy for clinical trial recruitment it could incorporate databases, social media, patient support groups and networks of doctors.

Against a backdrop of cynicism among a section of the public towards pharma, it’s worth remembering that for some patients, clinical trials are their only treatment option. Taking part in a clinical trial offers an opportunity; a possible lifeline. From a communication perspective, it is of course vital that a trial is presented in a fair and balanced way, but for some patients it represents a chance to participate and one they would wish to hear about.

Raising awareness of the importance and opportunity clinical trials provide, will help improve healthcare outcomes for everyone. And the growth of databases containing potential trial participants is an important part of that.

The communication challenges around clinical trial recruitment can be complex, but central to it all is the need to build trust. The way clinical trials are conducted has changed – from the databases to Zoom, decentralised trials to remote participation – all made possible with technology.

The technology has often led to better efficiency as it removes some logistical barriers – people don’t necessarily have to come to hospital – but it has also removed some of the human element.

That bespoke experience which healthcare professionals can deliver – how a doctors, face-to-face with patients, can pick up on the subtle cues and tailor their words accordingly as they talk about the risks and benefits of a clinical trial.

By witnessing someone’s reaction they may be able to pick away and unearth a limiting belief – one that upon questioning, or honing the detail of, helps patients to see the benefits of taking part in a clinical trial.

If the power of human interaction is removed, or reduced, it will make it harder to build trust around clinical trials. Worries over data privacy also exacerbate this, which means communicating what will happen with patient data – in a clear, approachable way – is paramount.

The industry needs to move away from onerous T&Cs and pages of legislation and look at how it writes consent forms, so that patients are better aware that they are not locked in, and they have the right to withdraw consent at any point.

Communications need to build confidence in clinical trial participation – explain that there are many safety mechanisms in place, run by people who can be trusted and that the technology available can make the process smoother. Making the digital experience more human requires more of a conversation – addressing barriers, resistance and concerns – and then it will feel like a more trustworthy experience.

So, our role as agencies working with pharmaceutical companies is to use our communication skills to build trust – by using patient insights and mirroring their thoughts, concerns and feelings.

It is possible to develop very powerful connections. If patients recognise themselves and their experiences in the communication, they are more likely to think the drug manufacturer understands what they are going through and how their lives are affected. This can cut through the noise and show that they are on the same journey and may reach a better place by working together.