COVID-19 changed the way that research trials were delivered. Prior to the pandemic staff working on research studies were based in academic or NHS buildings together with other colleagues. This changed in March 2020 when the majority of people started working from home. This accelerated the need for research to manage more information electronically including consent processes, Trial Master Files (TMF), site training and communication.
Nearly three years later, the majority of research staff are still working remotely. Research organisations have had to adapt to be able to successfully deliver trials.
Trials setup whilst staff were working remotely faced the issue of how a paper Trial Master (TMF) could be built. A TMF should contain essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. One of the solutions to this was to move to an electronic TMF (e-TMF), an e-TMF can be accessed and maintained remotely by research staff. There was also a similar issue in that paper Investigator Site Files (ISF) and other departmental files such as Pharmacy Site Files (PSF) couldn’t be built and sent to research sites. The solution to this was to use the e-TMF system and make the files available for staff at research sites to access, download and create their own site files or create and electronic site file. There are other solutions as well, such as making the files available through the trial website in a secure area. Trials looking at COVID-19 needed to be set up rapidly during the pandemic, and using electronic site files helped speed the setup of research sites.
Working remotely also meant that research staff could not travel to research organisations to conduct visits or hold face-to-face oversight committee meetings. Research organisations started using electronic workspaces; one of the most popular ones used is Microsoft TEAMS. This workspace allows research staff across the world to chat, meet and share documents online. Meeting virtually is a big benefit for delivering trials remotely; meetings can be arranged easily and can also be cost-effective. There are a few virtual meeting packages available to use including Microsoft Zoom Microsoft Zoom and Google Meet.
We also had to consider how trial data was collected and entered during the pandemic. Research staff were not in research organisations to enter the data from posted case report forms. The solution to this was to adapt databases to allow remote data entry at research sites. This meant that staff working from home could view the data entered and raise any necessary queries.
Delivering trials remotely may be the way that trials are delivered for the foreseeable future. We have learned from the pandemic and trials are being designed that include remote delivery. The NIHR Research Design Service can help researchers plan this. There is no doubt that e-TMFs and virtual workspaces are a great benefit to delivering trials. Even if the delivery of trials moves back to an office in the future, research organisations will continue to use e-TMFs and virtual workspaces; this could lead to trials being set up quicker which would require fewer resources and funding for setup.