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

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奥利维亚巴恩斯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.

对于每个人来说,我们都感受到了暂停动画的状态。我仍然要去上班,道路是空的。它只是所有人都会增加陌生症。

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.

当我坐下来做我的文书工作时,它并没有很好地与我坐下,因为我们努力努力避免。研究非常黑白,所以你必须搞定它并第一次得到它。对于任何协议偏差,您必须确保您记录一切,非常仔细地显示您了解您的偏差以及它发生的原因。

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 theMRHA added to their website说他们了解发生了什么,希望没有任何严重的违规行为来自它,因为他们理解原因。

Covid-19测试研究

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抗疟疾研究

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.

遗憾的是,这个来的一周我希望很多回复 - 这是不幸的,因为这意味着人们病了,但我们可能会在这个可怕的病毒中获得更多信息。在我觉得我只是在等待海啸击中我。

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

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