Coronavirus Diaries: Thinking outside the box to restart clinical trials with COVID-19 restrictions

Olivia Barnes is a Senior Research Nurse at Sherbourne Medical Centre in Leamington Spa. In this series of weekly posts she discusses how COVID-19 is impacting the clinical trials she is working on, as well as her work on studies in response to the virus. Read previous entries here.

Things have been much busier in the last few weeks, as one of the studies that was on hold has restarted. It is an observational study, following patients for a year for cardio vascular events.

Observational studies always look very simple, but then when you actually get down to it, it is a lot of work, because you are looking at source documents back to as long as the patient has been registered with us to get all the relevant information. It is the same with every new study - that first patient is a test of your knowledge of the protocol and study procedures. It is always a bit nerve-wracking as you've agreed to something and then when you get the first patient in, sometimes you see it is actually quite a bit more work.

For this study, obviously they've had to make amendments to do things by post. Questionnaires were either posted or emailed, and after the patient consents, they post it back for the Principal Investigator to check everything, counter-sign the consent, and then post it back out. So it is an awful lot of extra work. The patient doesn't have to come in at any time. They would have come in for a baseline visit and I would have tested blood pressure, weight and so on, whereas now there is an amendment to take the latest blood pressure and weight, as long as it is within a set timeframe. So it has been quite a challenge changing how we would have run it, but it's working - our target was ten, we've approached eight people so far and had four consent.

Hopefully some of the other studies will start again soon - lots of the Sponsors are tentatively asking how things are at the site and how prepared we are. We have got lots of guidelines from NHS England and are following an SOP from them, but for us it is the patients having the faith in us to be willing to come in and see us that is most important. Give it another month and I think we will be significantly busier.

COVID-19 Studies

We're still continuing with the COVID-19 serology testing study and people are still willing to give blood samples for research purposes. We're also going to send out another text message for the principal study we are working on to update patients that the study has changed from an anti-malarial treatment to the antibiotic Azithromycin. With COVID-19 incidents going down nationally, they are not getting the numbers for the study.

We've been approached about a COVID-19 vaccine study, but with restrictions in place, we're not sure how that will work, so we're going to have to think a bit more out of the box. With vaccine studies you're looking at large numbers of patients, regular visits, and patients having to stay in the surgery for significant time after first dosing, so it is going to be very challenging. We're keen to do the study, but logistically we don't know how it is going to work - we're going to have to think very differently in ways we've never considered before.