Will remote clinical trials help or hinder?

People often take part in clinical trials because they like the experience and the human connection. It's social. It's rewarding, and it's supportive.

The recruitment of clinical trial participants is often one of the biggest considerations when it comes to establishing a clinical trial. Finding a group of individuals who are both eligible and engaged with the idea of taking part is challenging enough in itself – it’s then often made harder by the fact that they all need to be within reasonable travelling distance of the trial’s site. As an example, there are roughly 2.5 million people in the world with multiple sclerosis – but the distribution of this population is uneven. So, if a sponsor was planning to launch a clinical trial for a new treatment to support this illness, they’d likely be able to recruit well in the West of Scotland but might struggle to find a sufficient number of participants in a country closer to the equator, in spite of there being many with a vested interest in new treatments.

Contract research organisations and clinical trial companies have long been looking at what they can do to overcome the hurdles that prevent people from signing up to studies, from increased paid marketing to more frequent communication with local GPs and patient groups. But one of the more recent proposals, reinforced by the ongoing presence of global lockdowns, is the option to manage clinical trials remotely. 

We all embraced a more virtual world last year, which brought both challenges and opportunities. It’s true that if companies had the equipment and training in place for remote trials or if sponsors and ethics allowed for virtual visits as part of the study design, some of the trials that were forced to stop during our current crisis, might be able to continue without the need for 100% physical human contact. It’s therefore an innovation that has increasingly played on the minds of many in our industry as we seek to find viable ways that enable us to continue our work in an effective way.

Remote trials can boost recruitment

Even beyond lockdown, remote trials could be seen as a solution to boost recruitment rates as it lessens the time-consuming burden of travel for some. This approach also opens the door to those who are keen to take part but simply cannot do so due to other commitments. However, when looked at in depth there are many factors to trial recruitment management which simply cannot be replicated in a non-clinical setting. One such factor is face-to-face interaction. When monitoring study participants, there is a lot that research personnel can gauge from body language alone as participants answer questions on their path through the trial. That element of communication is lost virtually, and so gathering participant data could become less accurate. There’s the tech itself to consider too, as clinic staff are at the mercy of a participant’s broadband connection or the quality of their device, which could see conversation strength vary considerably from participant to participant.

However, it is not just for data gathering that this is important; people often take part in clinical trials because they like the experience and the human connection. It’s social. It’s rewarding, and it’s supportive. For many older individuals, who tend to have greater availability to get involved, coming into the clinic is a preferred change of scenery. Some of these participants can feel isolated and we find that they come in on time, no matter the weather, and are genuinely happy to give their time in return for that added health professional contact and an important cause. Conducting trials remotely could lose us this reliable – and growing – audience demographic and result in poorer retention rates.

Why we conduct trials in a clinical setting

There are many reasons why we conduct trials in a clinical facility – it’s a professional and clean environment with medical equipment to hand and trained staff present. This is reassuring for study participants. It widens the scope of the procedures which can be carried out, but it also helps us make sure that study data is being recorded accurately. Standardised procedures are paramount in research to ensure consistency, so regulated procedures must be adhered to. The way in which you take a participants’ blood pressure, for example, could differ depending on whether they might be standing, sitting, or lying down. This is easily observed and controlled in a clinical setting, but if a participant took their own blood pressure, the study can lose that certainty and consistency. It’s worth noting too that, while not having to travel might help get participants on board, in some cases highly trained professionals must travel in their place if a home visit is required. This both adds to the costs of the study and prevents them from putting their time to good use.

Remote trials are complex in reality

The complex reality of remote trials is not one which is lost on those looking at how best to increase the ability and opportunity for study participants to take part. There are seemingly endless factors to consider, such as ‘How can temperature-controlled medicines be safely delivered under controlled conditions?’ Or ‘How can participants access more complex and often expensive medical equipment?’. But, if the impact of the pandemic has taught us one thing, it is that we cannot ignore the fact that remote trials could help overcome one of our industry’s greatest obstacles. ‘Help’ being the operative word.

Perhaps the answer is a hybrid?

We should work to strike a balance with a mixed model of virtual and physical study visits, offering participants flexibility, while keeping quality of interaction and of reporting standards high. As the vaccine roll out delivers hope and anticipation of life returning to greater normality, we must be open to the potential change in approach to clinical trials. Yes, this may vary depending on the study in question – no one size will fit all – but we must listen to what works well for our patient population in order to make it work well for the trial. I, for one, will be watching closely as to what is to come.

Author: Ellie Robertson is Managing Director at Intelligent Clinical intelligent-clinical.com