Hi, I’m Dominic from Shift MS, the MS Reporters series. Today we’re looking at clinical trials and we’re here at the John Radcliffe Hospital in Oxford. I was diagnosed in 1994, I’ve got relapsing remitting MS, and I’ve taken part in several trials here. So we’re going to go and ask my trial nurse, Ana Cavey, what her views are on patients’ concerns for clinical trials.
What consent is and why it’s so important and what their rights are.
So the first question I’m going to answer is how do we approach, how are we allowed to approach you about research, because everybody assumes that everybody has a right to research, which you do. We can’t go out and approach people, so how it works in Oxford certainly, is that we approach you to ask if you’d like to be consented to go on to – it sounds a bit weird – but the name is a tissue bank. That allows us to contact you about upcoming studies. You can contact us direct and you can say I’ve looked on the ClinicalTrials.gov website, I can see you’re doing this study, can I be involved, of course and we can take it that way. But for us to be proactive, we have kept a database, and that’s what it’s currently called. So every time we go on to that we need your consent. So you are consenting that we can approach you and with that one there’s other things about taking samples and whatever, but the process of consent is we will give you information about what we’re asking you to consent about, because often it’s different things, give you time to think about it, you can ask questions, and then you sign it, we sign it, and we keep that.
With any consent, be it about a tissue bank, be it about approaching you for information, or a commercial study, doesn’t matter what, you are allowed to withdraw your consent at any time. It’s not a commitment forever, it’s commitment for as long as you want to be committed to it.
So you can change your mind at any time, you can just walk away.
We will ask you why you’ve decided to withdraw consent, so that if we’ve made a mistake or we’ve handled something badly we can build on it. You don’t have to answer that question, but it’s helpful for us to know why you wish to remove consent. But no, you can walk away whenever.
It’s side effects, some of the things that you can read look so alarming and terrifying…
And, you know, maybe you can help put them in some context, because people worry about side effects. Personally, I think it’s a little bit unregulated to them, but yeah, it’s Dr Google.
Absolutely. So, one of the reasons that we’re doing the clinical trial in the first place is that we don’t know what the side effects are, so that’s why you’re closely monitored, why we do your bloods regularly, you come in and see us regularly, you’re encouraged to phone us if you feel unwell in between visits. So side effects is something, that’s the knowledge we’re trying to collate as part of the clinical trial. But side effects are a difficult, difficult concept – that’s not the right word – but a difficult idea. In the patient information sheet and when you start a trial, we tell you about every single side effect that we know about that drug, and it will be listed. And there will be common and less common ones that can happen to you, but we have to list everything. So if one patient’s had something, we have to put it on that list. So side effects is difficult, whether you’re doing clinical trials or not, because there’ll be a huge long list which looks incredibly scary. We have to acknowledge that they happen and that’s why we’re collecting the data, but it has to be put in some context. If every patient got every side effect of every drug we’d be in a right old kerfuffle. But I think it’s about having, we can only tell you what we know about, and if you’re worried, that’s why people who are involved in trials have 24/7 access to somebody on the trials team to reassure, but to monitor as well.
So, if I get put in a clinical trial, will it work?
That’s a very good question. So, a clinical trial, as we’ve said, is a comparison of standard care, so you’ll always be on the best available care versus a new technique or medication. And if anything new comes through whilst you’re in the trial that will always be added in. So a person will never lose out from the standard of care at that time. Of course doing a clinical trial is designed to work out if that medication does or does not work and until the results of the trial are finished we cannot know that in general for the people who took part. Of course with any medication for the individual, it may or may not work in a particular condition. So that’s maybe a long-winded answer to say that in a trial everyone is what’s called ‘blinded’, so no one knows if they’re on the new medication or not the new medication, including the doctors and the nurses, and it’s only at the end of the trial, which can be a few years later, can we actually know whether that medication has worked. So a person in trial will never know, in a way, whether it’s working or not, but will always be on the best available care. And really, I suppose a number of things, thinking about the trial from the individual’s point of view, but also, the benefit for the community for the people with MS, because medications that come into trial are very carefully chosen that they should be or could be successful, but until we’ve done this comparison we don’t know.
I’ve often heard about people getting paid to do clinical trials and sometimes you see ads, you know, come to London, get paid this silly sum of money, and my experience of being on trials was never that. Maybe you could help me understand the difference.
Right. So up until relatively recently we were only – there’s lots and lots of rules and regulations to protect the patient.
Law, yeah, absolutely. So giving consent and being involved in clinical trials, you are protected hugely. We follow something called GCP, Good Clinical Practice. We have not been allowed, we cannot incentivise you to do a trial and we cannot cause bias, so we are not allowed to pay you to participate in a clinical drug trial. So up to now we’ve been able to give you reasonable travel costs, so please don’t arrive by helicopter, we have to negotiate this beforehand. But, you know, we’re mean.
No, you always paid my train fare, was my recollection.
Absolutely. So, but there are several- or what’s becoming more common is that we will pay you for the inconvenience. So sometimes on some of the trials you will be given a small amount of money to pay for your inconvenience. That again is set, it will be written in the patient information sheet, you will be told about that beforehand. But basically, no, you don’t get paid for doing drug trials. The ones that you’ve probably heard about of going to London, they’ll be phase one studies with healthy controls.
Will being on a clinical trial cure my MS?
Okay, well that’s a big question. So I think it’s very important when a person with MS is going to take part that they look exactly about what the medication does. So, as far as we know, unfortunately at this moment in time there’s no medication that can cure MS. But it could be a trial of a new medication for relapsing remitting MS, against standards of care, does it reduce the number of attacks. Or in progressive multiple sclerosis, can it slow the progression, or even stop the progression. But of course one won’t know until the end of the trial. So, these are the general steps of what we’re trying to do in MS, but I think a claim that a drug could cure MS, I would treat with caution, at this moment. Unfortunately. Of course, we very much hope as the years go on that such an occurrence will occur.
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