Case study: Restarting Research Remotely

By Dr Aditi Kumar, Research Fellow
Gastroenterology SpR, New Cross Hospital

At the end of March 2020, the NIHR issued guidance for Trusts to focus on the delivery of UPH COVID-19 studies and those trials identified as life changing/saving, resulting in the vast majority of existing research activity being ‘paused’. This included our BAM study, which is looking at whether we can replace a diagnostic investigation with a simpler, easier to use diagnostic tool for patients with bile acid malabsorption. Our sub-study is further looking into whether microbial changes in patients secondary to specific medication can influence recurrence in post-operative Crohn’s disease. We had three sites open for recruitment pre-COVID, although the majority of patient recruits came from RWT (in total, we had recruited 100 patients over the past year).

In the middle of May 2020, we began down-phasing the redeployed staff, including the research fellow delivering this trial (Dr A Kumar) to return to their original departments and work. This research study is sponsored by RWT, with recruitment being undertaken at a number of sites including RWT – restart was undertaken as a 2-stage process.

Firstly, contact between the chief investigator, research fellow and the R&D team took place to review the viability and prioritise the study for reopening. Following a review of feasibility with the Chief Investigator, restart was agreed with the understanding that research nurse support would not yet be available whilst they were delivering UPH studies. The research fellow then took on these roles to enable the restarting of this paused study.

In between my clinical work and helping out with the delivery of UPH studies I have managed to work closely with the R&D team. This collaboration has enabled me to restart my NIHR portfolio study and I have now managed to restart recruiting participants remotely. We made changes to the recruitment pathway to allow us to provide most of the relevant study paperwork by post and to engage with them for visits by telephone. The only in person interaction was to deliver or collect specimens and this was managed by me alone to ensure appropriate social distancing.

Early in June 2020 I communicated with our previously open sites to assess local restart through the usage of the NIHR assessment checklist. A further new site was opened to recruitment at this time and all site initiation visits were held remotely quickly and efficiently to begin recruitment. Finally, once the site was open I delivered the relevant sample collection equipment directly to the local R&D team using relevant PPE and maintaining social distancing.

Although I was given the green light to restart the study at RWT, there was still a delay in recruitment as we waited for routine investigations and elective surgeries to restart again at our trust, which did not occur until mid-June.

Even then, services were being delivered at reduced numbers. As a result, I have managed to recruit 12 patients over the months of June and July.”

The restarting of this project has been enabled by working closely with our supporting lead and participating R&D departments. With clear and effective communication, we ensured that we can efficiently and safely deliver this research opportunity for our patients again.