In the week of International Clinical Trials Day, marked on 20th May, the latest Advances in Clinical Trials webinar introduced some of the recent developments in decentralised trials, with case studies from the UK and US. The panel was inundated with questions, so to pick up on the discussion on remote trials — its challenges and wins – we brought two of the panellists back together. Suki Balendra is Life Sciences Lead at North West London NIHR Clinical Research Network and Kristin Croucher is Vice President, Clinical Operations Europe at Lightship, a company pioneering virtual-first trials.
In the webinar, the point was made that COVID had forced organisations to rethink their approach to trials. What was the pre-COVID approach?
Kristin: The move to decentralised trials was already underway, and had been for several years, but COVID certainly helped to push it faster. People had to do things that might otherwise have been outside of their comfort zone. Now, people are realising that virtual trials are not only possible, but the right thing to do for patients. A lot of companies are now realising that decentralising trials helps generate better trial data, as well as more patient choice. The US Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are very supportive of decentralised trials, and European regulators appear to be becoming more open to it too.
Suki: In the UK, this digital revolution had already been underway before the pandemic. We had some decentralised trials activities – for example, going into patients’ homes, rather than them having to come to us in a traditional hospital setting. The pandemic did accelerate some of our activities in decentralising, but now we have the opportunity to put the right governance and systems in place, so that we can implement these new technologies quickly. The webinar was largely focused on how we can prepare for these challenges.
Kristin, you made an interesting point in the webinar about nurses going to people’s homes and perhaps being faced with uncomfortable settings for them. What sort of training do you put in place for them?
Kristin: It begins at the hiring process – you need people with the right personality, who are prepared to deal with such situations. We then do extensive simulations and practice runs of the procedures they will need to do in the home, until all of the small processes involved become second nature to them, so that in high-pressure situations they can focus their energy managing the unexpected calmly and helping the patient to feel relaxed. We do everything that we can to safeguard and support them, so that they can go into houses feeling comfortable and confident for whatever they might have to deal with. So it’s about who you hire as well as the training given to them. Finding nurses who can think on their feet and be accepting of anything and everything they may come across is crucial.
Suki, you mentioned that from the NHS perspective, nurses are used to going into people’s homes for home-care-related activities. Is additional training really necessary?
Suki: I think, in the NHS, we need to do a bit more cross-training between staff. For example, community nurses and midwives are used to going into people’s homes, and are accustomed to many of the difficulties they might face. Cross training nurses with these groups would have a big impact. We’ve been given funding to create a community team, which gives us the opportunity to hire the key people, like Kristin said. But there are a lot of people already in our teams who we may need to retrain for going into home settings.
There was an interesting point made in the webinar about the appeal of decentralisation and the extra flexibility it offers, helping to attract nurses back into the profession. What are your thoughts?
Suki: We’re still reeling from massive departures in the NHS, so the benefits of decentralised trials helping people to come back into the NHS probably won’t be recognised for quite some time. Having said that, the reality of decentralised trials could help people come back in the future. Some NHS trusts are becoming quite creative in how they train and use staff. For example, giving clinical nurses the opportunity to get involved in research for one day a week. There is some evidence that these dual responsibilities are quite attractive and helping with staff retention.
What proportion of trials are actually now virtual, compared to hybrid models or ones done in the clinic?
Kristin: There are very few trials that are fully decentralised, but as we move forward, every trial could have at least some aspects of it decentralised. In terms of trials that could become fully decentralised or virtual, I think it could reach as high as 25%.
And Suki, what are your thoughts on the possibilities of fully decentralised trials?
Suki: I think that sponsors could be drawn to this model for their rare indications – in cancer studies in particular, there are quite a high proportion that have rare indications. So as Kristin says, over the next ten years, fully decentralised trials could reach a quarter [of total trials]. Conducting more work in a mixed manner will surely be more attractive for everyone involved, though one thing to think about would be that The National Institute for Health and Care Research (NIHR) may need to think about how the decentralisation of trials is tracked and recorded in the system.
With the NHS and most organisations now focused on reducing carbon footprint, how does the carbon footprint of a decentralised trial compare with a traditionally conducted one? Is that being measured as well?
Kristin: We have spoken about how we can bring sustainability into trials, and with the new model of virtualisation, we’re beginning to see a lot less travel (not only patients, but also fewer flights for monitors as the source and Investigator Site Files become electronic, allowing for fully remote monitoring visits). The industry will need to think more about this issue in the future though – and how we could do things differently – as trials, in general, still have a high carbon footprint.
Suki: Of course, in reducing the number of visits for patients through telemedicine services and virtual education resources, this will have a positive impact in lowering the carbon footprint of trials. In the NHS, we will need to look at this together in terms of reducing the number of visits and therefore reducing the carbon footprint.
Watch now
For the full panel discussion, watch back the webinar here.
About Kristin
Kristin Croucher is a life sciences strategist who is passionate about the clinical research enterprise. Her experience includes two decades of managing various teams and implementing high-level, multi-national and niche clinical trial operations across Africa, USA, Latin America Europe, Asia and Australia. Currently, Kristin is Vice President, Clinical Operations at Lightship, a virtual-first and hybrid clinical research organization.
About Suki
Suki Balendra completed her PhD in BioChemistry at the University of Warwick and has held roles in industry, NHS, government and academia for almost 20 years. As Life Sciences Lead at the North West London NIHR Clinical Research Network, she was responsible for setting up the North West London Clinical Trials Alliance.