Remote, virtual, or decentralised clinical trials are nothing new, but COVID-19 catapulted the model into the mainstream. Now, as the sector settles back into something approaching business as usual, how can we ensure new methodologies are delivering for participants, sites, and the sector alike?
As the COVID-19 pandemic ricocheted around the world at the start of 2020, researchers were faced with a stark choice – go remote or go home. When teams opted for the former option, they found themselves having to learn how to deliver decentralised clinical trials ‘on the job’.
Enter the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Remote Trial Delivery Working Group, established in September 2020 to develop and disseminate processes and solutions to support investigators and research teams.
The group’s chair, Dr Camille Carroll, Associate Professor and Honorary Consultant Neurologist at the University of Plymouth, said: “When COVID happened, entire portfolios came to a grinding halt. The only way to get those studies up and running again was by delivering them remotely.”
“Investigative teams were having to rapidly put mitigations in place, and it wasn’t just about interactions with participants, it was everything that goes into delivering a remote trial.
“People were putting a lot of effort into answering these questions at site level, but not necessarily maximising the benefit of sharing what they’d learned.”
The original objective of the working group, then, was to share that learning with study delivery sites and protocol developers. Since then the audience has widened to include more of the research community, including R&D teams and ethics committees.
A practical consensus
Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document.
Currently available in draft form, it proposes “five key principles of remote trial delivery”: national research standards, inclusivity, validity, cost-effectiveness, and evaluation of new methodologies.
Dr Jennifer Harris, Director of Research Policy at the Association of the British Pharmaceutical Industry (ABPI) and Vice-Chair of the working group, told pharmaphorum that the document was designed to be a practical resource.
“Everything has moved so quickly. We are now two years into the pandemic, and while we are all talking about remote and decentralised trials, we haven’t really defined what that means. Part of the aim of this guidance is to start to articulate that.”
Dr Carroll agreed, adding that the practicality and accessibility of the advice was key to ensuring a smooth transition from face-to-face to remote and hybrid studies.
“It can be very difficult for people to get this off the ground without tangible examples, and real-world, step-by-step guidance,” she said.
What has come of the work so far is that any future model must be built around patient preference, and that every change must be based on evidence, rather than assumptions.
“There is a risk with anything new for it to become ‘the emperor’s new clothes’ and for people to not look at it critically. We were very keen to put a critical lens on this and make sure that any potential pitfalls were not ignored,” Dr Carroll said.
The ability to communicate with participants via video call may make the trial more inclusive geographically, but can also exclude people from a technology standpoint, for instance. The data protection concerns associated with sending a nurse from a third-party company to a participants’ home to collect bloods is another example.
“We just need to be aware of the flip side of each new part of the process we introduce,” said Dr Carroll.
Business as usual?
If decentralised trials are to become the new normal in clinical research, it is essential to make sure we are doing it right, Dr Harris and Dr Carroll explained. That’s why the next phase of the working group project will be implementing and evaluating the finalised principles of best practice.
“I think there is a risk that we just assume this way of working is better than traditional methods,” said Dr Carroll.
“We might, for example, assume that remote models will give us better geographical inclusivity, or will be less burdensome for the patient, resulting in better retention. But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”
We are, she said, in a transition zone, and the delivery group’s website, which is currently undergoing a transformation of its own, aims to help grease the wheels.
Over the next few months, it will be updated with a range of resources, case studies, and signposts covering the huge breath of considerations associated with delivering a remote or hybrid clinical trial.
Another benefit of the project, Dr Harris said, was that it will help showcase the UK’s appetite to embed new ways of working following the pandemic.
“We know that the UK healthcare system is delivering a more hybrid approach, that studies are coming to regulators with a variety of remote components written into the design, and that we have the ability to deliver clinical trials in this way across the NHS.
“But how do we package that up?” she asked, adding that outputs from projects like the working group demonstrated that the UK’s researchers are aware of the risks and benefits of decentralised trials and give patient preference the credence it deserves.
“Showing that we can translate our good understanding of patient preference into patient benefit with better recruitment, better retention, and greater diversity of participants could be a really phenomenal USP for the UK,” she said.
Getting it right
COVID threw the scientific community headlong into remote and hybrid trials as a necessity. But as we emerge from infection control restrictions, it’s time to take a step back and ensure we have the right processes, for the right people, at the right time.
Because getting it right could provide a win/win/win for participants, researchers, and the UK’s place in the international scientific community.
Read more about the NIHR Remote Trial Working Group and their preliminary guidance here.
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public
This post was originally published on Source Link