Vaccine trial team reflects on experience of collaborative working – a model for future studies?

As the dust settles on the recruitment phase of the NIHR-supported Valneva COVID vaccine trial (which has recently reported positive results), we caught up with those leading the study at two South West hospital trusts to find out more about a pioneering approach. Working collaboratively as a single site, the team recruited 266 patients, and learned valuable lessons for the management of future trials.

Dr Claire Bethune, Consultant Immunologist at University Hospitals Plymouth NHS Trust (UHPNT), and Dr Louise Anning, Respiratory and General Medicine Consultant at Torbay and South Devon NHS Foundation Trust (TSDFT), acted as Co-Principal Investigators (PIs) for the study. Ben Hyams, Lead Research Nurse at UHPNT, also helped lead a team of over 40 staff from both organisations to deliver the trial. The study was supported by the NIHR Clinical Research Network South West Peninsula’s Clinical Support Team (CST).

Louise: This was my first collaboration of this scale as a Consultant, though I had helped set up the respiratory network in the South West as a Registrar. Plymouth already had knowledge of running a vaccine study, and Torbay had that new enthusiasm - the team was chomping at the bit to do a vaccine trial. Together, it was a powerful combination.

Claire wanted it to be a completely joint collaboration, and thought it was really important that there was leadership at all levels from Torbay. Everything was run from one site but staff at all levels, from admin to doctors went over to Plymouth from Torquay on a rota. Participants were recruited from both sites, so that Torbay residents also had the opportunity to access the trial.

Benefits for patients – and staff

Louise: At the time we agreed to work together, I’d just come out of the Nightingale hospital, I was feeling somewhat broken from the winter and there was no way I could have done it without someone else. In a collaboration you’ve got the other’s enthusiasm and expertise to help you, and that really motivated me.

Also, having studies in your geographical area gives our participants access to potential new treatments, and that was a big driver for me.

Ben: It felt like everyone got something positive out of doing it, and learned something they wouldn’t have otherwise.

Why it worked

Claire: I think the collaboration at consultant level worked particularly well because Louise and I had previously worked together and had complete confidence in one another. From a PI perspective, you need 100 per cent trust.

Louise and I sat down right at the beginning with all the Sub-Investigators and went through when things might be challenging, so we were all coming at it from the same angle. We also had a doctors’ WhatsApp group for clinical questions, so we could have a really speedy dialogue. I think the junior doctors felt really well supported.

Ben: It did feel like there was more conformity in decisions from the doctors through this way of working.

For me, the collaboration worked because there was trust in each other’s professionalism.  People were coming prepared to work hard, and were up-to-speed with clinical and research skills. Our educator had worked hard to make sure that was the case and I think it really paid off. A lot of the pre-training was done through NIHR Learn and had been set up nationally, but it worked really well. It meant people were well prepared, but also were very willing to say, “why don’t we do things slightly differently, why don’t we try this instead”. We tried to involve the team from Torbay as much as possible in the planning. I think both teams had a sense of belonging rather than it being a case of just bringing a couple of people in.

We also had really thorough pre-screening of participants, which was quite challenging over the phone, but well worth the effort.

Louise: I think in a way, adaptations enforced by COVID helped. Before, we all worked in silos, but the pandemic has broken down those barriers, and we’ve realised that what we can achieve together is so much more than if we’re all individually trying to cross the same hurdles and find solutions to the same problems. The way we communicate has also changed completely with virtual meetings and working.

Challenges

Louise: There was a crisis point in May when it looked like we might not hit our target, but the team pulled together, extended by a week and made it. There were cheers in the office at this end!

Ben: The biggest challenge from my point of view was training, because we were using a new system (NIHR Learn) and doing it remotely. People might have thought we were jumping through hoops, but it’s important in research to do things to as high a standard as possible.

The other difficult thing was that as we went through the study there were more and more people being offered the deployed vaccine, so we had an ever-decreasing pool of people who were eligible.

Claire: Changes in national vaccine policy made recruiting to the trial more of a challenge. That’s why it was such a triumph to get to target. Having been involved in a previous COVID vaccine study we knew that there were likely to be a number of amendments to the protocol, our communication strategy ensured that the whole team stayed absolutely up to date.

Learning and successes

Claire: Having more than one consultant involved in the study has allowed us to support each other when there were challenging clinical decisions and to provide cover for leave.

Louise: I’m a lot more confident now to deliver a vaccine trial on my own in Torbay, or to support someone else, and it’s definitely increased our confidence to do further collaborations. It has been a fantastic, positive experience, and not just for me – feedback from the nurses and all the other staff has been uniformly really positive. I’m really glad that Claire did twist my arm at the beginning!

Claire: It was an incredible achievement to reach the recruitment target, both teams worked so hard and really pulled together. I think the biggest learning for me was the importance of a reliable communication strategy. We had formal meetings but also lots of WhatsApps for quick messaging. This meant that Louise and I could provide support to the whole team even when we were not on site.

Ben: Among the nursing team there was apprehension at first, as it wasn’t something we had done before and we were worried about asking people to travel from Torbay to Plymouth. The team were fantastic and this really didn’t seem to be an issue for anyone. As I said the biggest challenge was the training and education, and it really highlighted the need to have agreements in place across trusts on this.

There’s also an ongoing discussion about how to provide 24-hour cover at PI level for research in general, this was a good example of how that might work.

Claire: The shared responsibility and effort to achieve our target across both teams was extraordinary. Both teams could see everyone going that extra mile, it really was a privilege to work alongside such dedicated colleagues from Torbay and Plymouth.