Hi, I’m Sarah, I’m an MS reporter from London in the UK and I’ve been living with MS for 12 years. In this new episode of the clinical trials series I’m going to be discussing with Dominic, who’s another MSer, about clinical trials. Dominic’s had quite a bit of experience with clinical trials and MS and hopefully his insight will help shed some light on the pros and cons as well as what it’s like to be involved in a trial.
What’s in it for me or for the person taking part?
That’s a good question. I think there’s probably three parts to the answer. The first one is, it’s like private healthcare. It really is. It’s being paid for by the drug company. You get seen, on average, at least once a month. Blood tests, your health is monitored better, you have more time to talk to the clinical staff, they explain things. The attentiveness to your health goes up, you feel better as a result, people listen to you, you find out things sooner, you get things sooner. The second thing is the altruistic, so you might just be helping in a study. I was in an MRI once for two hours where I put my finger up and down when the red light went on so that they could see which part of the brain was activated. Nothing in it for me, just helping out. And then probably the most important thing, or to most people, is the idea of getting a new drug. And when it gets to the main trials that most of us would be involved in, the phase three trials, you’ve got a chance of getting – chance fifty-fifty because it could be a placebo – but you may get a new drug.
And could I die if I was on a clinical trial?
We very much hope not. In a clinical trial, again, there’s a lot of attention paid to safety. So in a clinical trial there would be a lot of monitoring of the person, a lot of blood tests, there’ll be emergency phone numbers. There’s a huge safety piece about being in a clinical trial, so if anything untoward was happening, the study team would react very, very quickly. I suppose it’s not impossible that something terrible would happen, but it’s really highly, highly, highly unlikely and it’s very, very tightly controlled.
What happens at the end of a trial? So I’m taking a drug on a drug trial, they finish at some point, what goes on?
Absolutely. So when you sign up for a trial, on the very first day, the patient information sheet will be very explicit about how long you’re in the trial for and when a trial finishes, one has to assume that that’s the end of it, there is no more. You’ve participated in that trial for three months, five years, whatever the pre, the length of time was specified at the beginning, there can sometimes be a follow-on, and I think that tends to happen more and more, especially with the phase threes. So if the drug, and during the trial there will be various committees that will sit to make sure that the drug is obviously not harming you, but also, does it reach a certain end point. And if it appears that it’s successful they will quite often – not always – but quite often they will offer a open label extension. So in a phase three study there is usually in the world of MS a placebo arm and a drug arm, and there may be multiple drug arms when they’re given at different dosages. An open label study will use the same patients that were in the original study, but they will convert everybody on to the real drug.
That’s what I went on, was one of them, yeah.
Absolutely. And then they will follow the patients for a set number of years after that. Why do they do open label trials? The reason for that is that what’s important when you’re going for licensing, or one of the important things is patient on drug years. So you can have a thousand patients on a drug for a year or you can have 200 patients on a drug for five years. The licensing authorities’ll be interested in the ones where you’ve got more patients on it for longer. An open label study is a way of capturing extra data in a trial situation and it’s also a way of the drug company saying thank you to the patient. If it’s an efficacious drug, you’re then going to get it for a further length of time.
So, if you’re thinking about going on a clinical trial, how much information are you given before you start?
More than you could imagine. They, safety is at the highest priority these days. I think it’s important to add you can leave a clinical trial at any time for any reason. You don’t have to give a reason, in fact, you can just say I quit, and walk off and they can’t even say a word to you. It’s, thank you very much for helping, bye bye.
So what made you get involved in a trial?
I have always had a very progressive attitude, I suppose. And partly because when I say progressive attitude, I mean I worked in the pharmaceutical industry. I’m a believer in the scientific method, I’m a believer in the fact that this is how medicines get developed. I also have pure self-interest, I want to take the best that I can get, as soon as I can get it, or sooner, possibly, but I am willing to give things a go.
What would be the main questions that you would suggest the MSer asks themselves before they put themselves forward for that trial?
I would find out, (a) if where I was being treated was a research centre, because not all hospitals do trials and in the UK the main ones, you tend to get London, Cambridge, Edinburgh, Oxford, Bristol and one other, Sheffield, and yes, so it’s almost guaranteed that any of the big trials will be running in one of those places. So if you live further away from them it could be difficult because you may find it burdensome, even though they pay your travel costs to get in and out on a monthly basis.
And have you ever had any, I suppose, bad effects, side effects or the way you were treated or the information you were given? Anything that wasn’t a positive experience in a clinical trial?
Never anything bad that I would put down to a trial. I’ve had side effects from drugs, no doubt about it. One of the drugs that I took for a long time caused me flushing. I would go bright pink for 45 minutes every day at about 11 o’clock. And you would look at me and think, that’s odd, what’s happening to him. And it started here and it went up, and then it just passed. But you get used to it after a while.
Is there any kind of advice you’d like to give anyone who’s considering it or may have thought about it, or is a little bit scared, what would you suggest then, except the…
Ask questions, you’ll find people are incredibly nice and helpful, and if they’re not, walk away. It’s highly unlikely, but it’s you, it’s your body, it’s your MS, ultimately you can walk away. I would encourage anyone to be on the appropriate treatment for them, you know, it’s a different world, but you’ll be taken gently into it because nobody wants to bully anybody into this. And I would encourage people, it is a known factor that when you get better attention in your health, even the time to talk, this face-to-face time and everything, your prognosis improves, your happiness improves. Many illnesses are better when you’re happier.
So by that, even a placebo would actually bring out a better outcome.
Placebo effect is incredible. But this whole personal interaction – you and the nurse, you and the neurologist – the whole thing, I mean I’ve actually made some friends in the community that I never would have.
So there you have it, and hopefully this leaves you feeling a little bit more informed and perhaps more interested in finding out more. What’s your thoughts? Pros, cons, did we miss anything? Do you agree or disagree? Thanks very much for watching. If it’s been useful, please subscribe for lots more MSer driven expert questioning. And stay tuned for Episode 4 about how to get involved in clinical trials. See you then.