This document provides a fully accessible transcript for the video: The PD-STAT Trial: Paving the way for the future of remote trial delivery
Text on screen: Paving the way for the future of remote trial delivery
Camille Caroll:
My name's Camille Caroll. I'm an academic neurologist based in Plymouth, and I am the chief investigator of PD-STAT, which is one of the first academic multicentre studies of a neuroprotective treatment to be trialled in Parkinson's.
Text on screen: The NIHR Clinical Research Network supported the trail delivery from the outset
Camille Caroll: It was great being able to work with the CRN when we were setting up the study. We utilised resources to do early feasibility assessments of sites and allow sites to express interest. We designed with them a questionnaire that we could send out to sites to really get a feel for how sites might be able to deliver patients for the study, bearing in mind their competing pressures and the capacity that they felt.
Text on screen: The trial was designed to be as straightforward as possible which meant it was flexible when challenges arose
Camille Caroll:
One of the advantages of having simple delivery at sites meant that we did have flexibility, and we could incorporate new ways of working into the study as we experienced challenges that became more apparent as the study developed. So to give you an example, one of the challenges that we faced, particularly with recruiting across quite a large number of sites, quite a few of which were based in rural locations or served a rural community, was patient access to the study visits, which became much more onerous for them as time progressed and throughout the course of the study. So one of the ways to mitigate that is to offer home visits for participants, so they don't have to travel sometimes up to two hours to get to a study clinic. Another aspect of flexibility, which we were able to very quickly incorporate was necessitated of course by the COVID situation, which arose probably two to three months before we were due to close the study. So just at the very end of the study, and for us, this was really important as this meant that our primary outcome visits were affected and also our follow-up safety visits.
Text on screen: The NIHR supported the study to transition to a virtual approach
Camille Caroll:
So for sites where there were no longer staff available to deliver those last assessments, we were able to implement a practice of cross-organisational working, which actually worked really well. So our rater based in Plymouth, working with the PenCTU and the Trust was able to offer research assessments through the video platform or through telephone contact with participants in other sites, and what we needed in place to facilitate that was approval from the sponsor, and again, they were very flexible and speedy in dealing with our request. And we also asked study teams at those sites to obtain consent to contact so that they were able to share contact details with our research staff based here in Plymouth.
Text on screen: The PD-STAT trial was forward-thinking from its inception
Camille Caroll:
The other type of measure that we incorporated in PD-STAT from the outset, because we could see that the way that the future trials was likely to develop was some digital measures. So one of these was an internet-based measure of tapping speed called the brain tap test, which was actually delivered at study visits, as was the other measure, which was a sensor worn on digits for people to undertake the tap tapping and hand movement tasks. The idea being that this would give more detailed and granular data about movement than one might be able to perceive by eye if you're visually rating a task. So these were the measures that were available when we set up the study, and of course, nowadays there even more sophisticated digital measures, including smartphone app interactions or wearable devices or smart devices in people's homes.
Text on screen: The trial benefitted from the expertise available due to the support infrastructure provided by the NIHR
Camille Caroll:
I think without having the infrastructure support available at sites, we would have really struggled to deliver the study. The infrastructure provided a stable staff base, which meant that staff on the whole we're able to support patients throughout the two years of being on the study, which was really important for patients, and of course, for a neuroprotective trial, particularly one of that duration, patient retention to ensure that we're able to meet our primary outcome is really important. So I think without the support of the CRN, this would not have been a study that had been possible to deliver.
Text on screen: The UK’s ability to deliver clinical research during the pandemic is a great achievement
Camille Caroll:
I think the UK's response to the COVID pandemic in terms of its research delivery has really exemplified all that's best in terms of what can be achieved within the UK in terms of delivering clinical research. We now have the opportunity to build on that and ensure that what we've developed becomes truly embedded in new care pathways and a new way of delivering research, which is better for teams, better for patients, and better for sponsors. And I think the UK will be a great place for studies to be based in the future, as we have all of the individual component parts working together, facilitated by the NIHR with really good communication and dissemination processes and infrastructure in place, which allow for best practice to be shared, problems to be mitigated, challenges to be identified in a way that is rapid, flexible, and adaptable.
Text on screen: NIHR. For more information visit: www.nihr.ac.uk