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Coronavirus Diaries: Protocol deviation in clinical trials during COVID-19

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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 two studies in response to the virus. Catch up on the first entry here.

For everyone, we all feel in a state of suspended animation. It is personally very strange that I'm still coming to work and the roads are empty. It just all adds to the strangeness really.

At the minute we have four studies that are on hold and then we've got another two that we hope we will start soon, but in the current climate, they may well be put on hold as well. So it’s a big blow to the financial side of things.

 

Protocol deviation

The main thing that has been on my mind this week is protocol deviations. It's something we try our absolute hardest never to have normally, and yet the minute they are coming thick and fast. Things that are meant to be done in person, such as blood pressures, taking temperatures and the doctor listening to their chest - all that can't be. So we have a detailed telephone call and listen to what the patient is telling us without doing the physical checks that the protocol sets out.

When I'm sat down doing my paperwork, it doesn't sit very well with me, as it is something we strive very hard to avoid usually. Research is very black and white, so you've got to get it right and get it right first time. With any protocol deviations you must make sure you document everything very, very carefully to show that you are aware of the deviation and why it occurred.

We obviously want good data, and we want to do everything we possibly can in the studies, but at the end of the day, it's the patients’ safety that overrides everything. It's not working out too badly at the moment, but it does add to the strangeness of the whole situation.

I must say it was very reassuring what the MRHA added to their website saying they understand what is happening and hopefully there won't be any serious breaches coming from it because they understand the reasons.

 

COVID-19 testing study

For our study on COVID-19 testing, unfortunately the people who may have been eligible have had their symptoms for too long, so weren't eligible. The patient has to have a temperature and a cough, but the swabbing test must be taken within seven days of the first symptom.

So as soon as the doctor is happy they are eligible, I would get the test kit to the patient. I will either ask someone who does not live with the patient to collect the kit from the surgery and then post or if that is not possible I could take the kit to the patient myself and wait for them to take the swab, then take it straight to the Post Office.

 

COVID-19 anti-malarial study

We sent out over 2000 text messages this morning (Tuesday 14 April) for a randomized study for an anti-malarial drug as treatment for COVID-19 for the over 50s. It's the first time ever that I've sent out that many text messages so I really don't know what to expect. I've got enough medication for 16 patients, so that would be 32 in the study given that it is a 50-50 randomised trial, and if I get those, I can order more.

Anyone who wants to take part should reply with an email straight to the study centre, but in my past experience most people will still phone here to find out more because the texts are coming from us. The process is all done online; everything from consent to the daily questionnaires, so unfortunately if they don't have access to the internet they won't be able to take part. All our text messages went out to the over 50s, with no upper age limit, so it's going to be quite hard telling people that for this study, it is online only. It would just be too labour intensive and too difficult to do it over the phone. I think if it was a study we were taking time over, you could have paper versions of everything as well, but not for this.

So unfortunately, this coming week I'm hoping for a lot of responses – it’s unfortunate because it means that people are ill, but at the same time we might get some more information on this horrible virus. At the minute I feel like I'm just waiting for a tsunami to hit me.

Find out more about the studies or if you are interested in taking part in the trial, visit the Sherbourne Medical Centre website.

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