So if you were invited to take part in another clinical trial, would you?

If it was like similar to the one I’m doing now and not have to take a long time, I probably would. And if mum wanted to do it, because like it, she has to sort of take time off work and stuff.

Well, it’s like you know everything, so nothing’s like hidden. They don’tBecause like during the trial there was a woman, like an older woman on it and she died. And they like came and told you. And they said that she was on a lot of other medicines and she was like quite ill, so there was a lot of ways she could have died. But it wasn’t necessarily that. So they don’t like sort of keep everything hidden. And they’re all really friendly and nice and look after you. So it’s quite good.

How could they, or is there a way of improving it?

Well, they could, like say if I wanted it to go faster or something, they would like try and like speed things up possibly. I don’t know.

In what way speed, speed what up?

Well, try and get all the information through faster. But they do it quite quickly already, so like there’s.

Do you mean the information they’re collecting the data over three years?

I mean like when they take my blood tests, they have to like check it and thenWell, they text my mum to ask her to weigh me, so then they could like get the right dosage for the medicine. So that speeds things up a lot, because if I just get weighed at the hospital and not at home, then it takes a long time to make it. But it’s already made for me now. So they’ve speeded it up.

Just describe to me all the tests and things that you’ve had to do?

Jenna’ I’ve had to have like this thing under my skin for TB and like the next day I had to go to the doctor’s, or like 24 hours or something. And it, if it swelled up that means I’ve got TB and I couldn’t do it if I had that. And they did an X-ray on my lungs to see if I’ve got it. And they did an MRI, which is where they like, sort of like magnets and they sort of look inside you and you have to stay really still. And like I’m a bit claustrophobic so I didn’t really like that. But like they have little videos that you can watch, like The Simpsons and stuff. And so like you can watch stuff, like you can lie down and you have these like mirror glassy things like so you can like be looking at the ceiling but you’ll be able to see it through all the mirrors. I don’t think I had to do anything else.

Mum’ X-rays, normal X-rays.

Jenna’ The X-rays.

Mum’ The main thing is the blood tests. And they regularly, they regularly test the blood at first to make sure that everything is going okay and that she’s reacting okay to the medicine. But once she’s been on it a while it’s just done on the day that she has the treatment. So it’s a lot, a lot better now.

Jenna’ I think at first I was a bit worried because like I had to have loads of blood tests and I haven’t had them that often. But now I’ve sort of got used to them and like I’m not really that bothered about them anymore.

Most things that children say, they don’t like blood tests.

Jenna’ Because like everyone asks me if it hurts and I say like it doesn’t. Because like we had, we had to have like injections and they were like, Which hurts more, blood test or injection I was like, Injection And they were like, Really and stuff. But they give you like loads of options, like you can have this spray that sort of numbs and then you can like get cream as well. So, but I didn’t really have any of that.

So you were brave then. I think they call it Emla cream or something, don’t they? Magic cream?

Jenna’ Yes.

So, but, so you’ve got used to having the blood tests now? And do they take much blood?

Jenna’ No. Just like a teaspoon or something usually. it’s not that much. It looks a lot more but it isn’t actually that much.

Jenna’ Because like it doesn’t take that much time for me. Because it’s only like a day and then I get home. And like I’ve got the rest of the month, so I just sort of like forget about it. And then I’m like, and then my mum tells me, Oh, you’ve got the hospita and I’m like, Oh And like forget. So it doesn’t really like bother me that much.

Mum’ I think she actually enjoys going.

Jenna’ Yes.

You enjoy going?

Jenna’ Yes, because I get to miss school.

Mum’ And she gets time to, she reads magazines and watches a bit of television while it’s happening and, so it’s actually quite a cushy number.

Oh, right, so you quite look forward to it? Oh, well, that’s good, isn’t it? So they obviously make it pleasant for you – as they can. And do they, when you go in to that room, you sit in your chair, your armchair, do they have things for you to do like that? Is there plenty?

Jenna’ Yes, they have like a cabinet of like movies and like TVs and stuff. I think they have some toys in the waiting room, so you could just like play with them if you wanted.

Are they toys that you’d like to play with?

Jenna’ No.

they’re for younger

Jenna’ I saw a man playing with them once.

Did you?

Jenna’ Yes.

Well, men would wouldn’t they, you know, toys and gadgets, probably had lots of buttons on or something.

Jenna’ No, it was just like little building blocks.

Oh, was it?

Mum’ Boredom.

Yes, boredom. I was going to say, is it boring just in there?

Jenna’ Not really, because like I bring my DS and stuff and magazines.

And did they say what the side effects might be?

Jenna’ I can’t really remember, but I think they did say some. But I do remember that rashes were some like common ones.

Were they?

Jenna’ Like dry skin.

Have you had any of them?

Jenna’ Yes.

Have you?

Jenna’ It was just like a bit of eczema type stuff, like under my eyes.

What did you do, what happened when you had, started to get some of the side effects?

Jenna’ Well, when I got dry skin I just used a moisturiser. It, it like went away. I just have to keep putting it on. Because like when I wash my face it feels a bit dry, so I just put some on.

What were the other side effects?

Jenna’ I can’t remember.

Mum’ Stomach ache.

Jenna’ Yes, stomach ache after it. But that, I don’t really, that doesn’t really happen anymore.

Mum’ No, it only happened for the first few times and then I think her body got used to it.

So you did have a bit of, so you’ve had one or two
Jenna’ Yes.

eactions then? But they’ve eased off a little bit?

Jenna’ Yes.

Did it worry, you know, when they, when you did get the stomach pains and the dry skin, did it, did it worry you at all?

Jenna’ Not really.

Why was that?

Jenna’ Because like it was just a stomach ache and it, like it went quite quickly sort of. So I didn’t really think it was that bad.

It wasn’t like a, what sort of a pain, was it a?

Jenna’ It was sort of like a stitch, but like just in my lower stomach.

Just a bit of a niggly pain? Did it, you know, did it, was it like last a long time or did it go away quite quickly?

Jenna’ About twenty minutes or something probably.

And that was soon after you’d, soon after you’d had the drip? Was that soon afterwards?

Jenna’ Like a day or something, a couple of days.

Mum’ She would complain on and off for a couple of days maybe after the treatment. It would come and go, wouldn’t it?

Jenna’ Yes.

So it was doing, it was obviously doing something to make you just feel a little bit out of sorts. You didn’t feel, did you feel a need to ring the hospital at all?

Jenna’ No, but like they ask us if we’ve had any side effects or like any, like if we’ve felt sick or if we’ve had any colds or anything, so they can like write it down. So my mum told them when we went.

And do you have to report like every time you go and have your drip, your cannula and you have your drip and you’re going for the day or half day?

So what happened at the beginning then? Tell me about that.

I think I went like every two weeks for a blood test and then for the thingy. And sometimes I had to go in every week at one point. And so it changed. And there was like a blind part of the trial where you didn’t know if you were getting like a placebo, like a fake one, or the real one, to see if it was just sort of like in the mind that you, it was working or if it actually was working.

And do you know what you were on?

Not yet, no. Because it, I’ve finished the blind part but they haven’t told me yet.

So you, you’ve finished that part but they still haven’t, are, are they going to tell you?

Yes. They need to find the paperwork with it on I think.

How did you, when you signed up and they said, they probably said to you, This is a
randomised placebo controlled tria did they mention that in the information you had?

Yes, they like went through all the stages in it and saying like there’ll be a blind part and then there’ll be like fasting ones, and like told you everything you had to do.

And what do you understand about randomisation and placebo?

Yes.

What, how can you, if you were to explain it to somebody, how would you explain it?

Well, a placebo is like a fake one that doesn’t really do anything. And like it just sort of, like it just sort of is like random and you don’t know what’s happening really in some parts of it.

And how did you feel, that you might be on a placebo?

Worried, because it might like flare up. But it didn’t. So I think I was on the real one.

It is a bit of a worry when you don’t know what’s, what you’re having. Do the doctors know what they’re having?

Mum’ No, nobody knows.

So they call that sometimes double blind, when even the doctors don’t know. So did that worry you at all?

Not really, because like I’m sure they could find out if they really needed to, if it was an emergency.

They said that you can escape. If she started flaring up then they would automatically put her back on to the real thing. So if, if anything did happen in the blind part you just come out of it and back in to the normal drug.

The normal treatment or the usual treatment
Yes.

hat you were having?So they were monitoring, so if something happened did you have a number that you could ring up?

R’ [um] I think we would just ring the hospital if something happened.

What was involved and how, how was that?

Jenna’ Well, I had to get up quite early to go to the hospital. And when I got there they’d like, they’d put a cannula in my arm and take some blood, because like you have to take different measurements like each time because they’d like test different stuff with it. And then they would like make the medicine. And then they’d just like sort of hook me up to it and it would take about, about an hour or something or an hour and a quarter to do it. And like during that time they had to like sort of do my blood pressure and my temperature and my pulse and stuff like that.

Did you have to go into hospital to have that done, to stay in, or did you have an outpatient?

Jenna’ No, I stayed in.

You stayed in? How long did you have to stay in for that?

Jenna’ Well, it depends really, because like they do different stuff. Because sometimes I have to fast, so they do that quite quickly because like I’m hungry. And sometimes it can take quite a long time, because it takes a couple of hours or something for the medicine to like be made.
Mum’ She goes on to a day ward. So you, you’re more, she’s not really an inpatient as such. it’s just a ward for things like dialysis I think, you know, things that need doing regularly. But they can just come in and have it done and then go home.

So there’s like a bed for you?

Mum’ A chair.

Oh, a chair.

Jenna’ There are beds.

I hope it was a comfy chair.

Jenna’ Yes.

I’ So how many times do you have to go?

R’ [um] well, now I have to go once a month for about half a day or something like that.

I’ And has that always been or has that changed over time?

R’ [um] it’s changed, because like I had to go every two weeks for blood tests and then like once a month for the thing. So, because there’s like different parts of the trial.

so you go for the day and you have a cannula inserted every time for the drip? How does that feel, when you have that done?

R’ Well, it’s just like a sharp scratch. But you don’t feel anything once it’s gone in. And it’s just quick. But sometimes they can’t find the vein and like it goes all weird. So that sort of like makes me feel a bit queasy. But it’s not really that bad if it goes right.

I’ If it goes right, yes. And hopefully the nurses get it right every, nine times out of ten. And, and you’re there then for the day. How long does the drip take?

R’ [um] About an hour or something like that.

M’ I would say an hour and a half to two hours. Because they have to put a flush, what they call a flush through after the drip. And then you have to stay for a while after that before they take the final set of observations before you’re allowed to go home.

How would you explain a clinical trial to another young person?

Well, it’s like they have a medicine, and then they sort of ask people to take part in this trial so they can like monitor the side effects and what happens and like how it works and stuff, just to get more information on the medicine.

Mum:They, they gave Jenna a video specifically for children to watch. And we took that home and watched that and it explained it better for a child to understand exactly what to expect.

Well that’s useful to know, that they had a video. So that was it,there were some nurses and doctors talking on that?

Jenna:It was like a child talking and it was like a cartoon of what was happening.

That’s good then. And that was aimed at, explained to you a little bit more about the trial that you were taking part in and the drug?

Jenna:Yes, like the trial and what would be happening and like what they’d be doing, like blood tests and stuff.

And so in terms of the drug, when you had the information and everything was explained to you, was it kind of in simple words or was it all like —- bullet points? Was it long, or was it long, short or lots of pages?

It had about, it had quite a few pages but not like loads. And it was, some of them were in bullet points and then there was like paragraphs. So it was a bit of both really.

Did you think that the layout was fine?

Mum:They gave two different lots of information. One for Jenna, the book was Jenna’s to read, which was designed really for the children to read and, and look at. And then they gave the adults other information, which went into it in more depth really. So we were both informed of the same things but in different ways really.

Just to make sure everything was you understood everything that was going on? Did they mention the names of the drug company at all?

Jenna:Probably, but I can’t remember.

I was going to say, is that important to you, to know that? Where the drugs are from.

Jenna:Well, not really.

Perhaps your mum might, you know. Is, is, do you think that’s important for you to know, whether they’ve been or whether it had been tested before?

Mum:I, that was important to me. I was very, they, although this was a new trial, they’d done two, I think two other trials on that drug to assess what dosages worked best and so on. So each trial has a different objective. And the objective of this trial was trying it on people with the same condition as we had. So the other trials had sort of already decided what dosage would be needed. And I was interested to know what the really bad side effects were. I was very worried about the fact that some people had died. And, as I say, that was, you know, I, I really, and I actually said to the doctor, If it was you and it was your child, would you do the drug, would you go on the trial? Do you think the benefits outweigh the problems? And she said, Yes, I would. So that was, that gave me a, some confidence.

Did that reassure you?

Mum:Yes. But I mean there are always risks with any drug. So I felt that the benefits outweighed the risks really.

Jenna’ Because like all the other options were like sort of injections you have to do yourself like in your leg and stuff. And I don’t like injections. So I didn’t really want to do that.

So by taking part in the trial, hopefully taking a drug instead of injections is that what will happen?

Mum’ Yes, she’ll stay on the, having it by drip until, for the foreseeable future. Whether they’ll, in the future they may turn it into an injection, I don’t know. But at the moment it can only be given by drip.

I mean what was, what’s the key, your motivation for wanting to take part? Why do you want to do it?

Jenna’ Because like to sort of like take all the pain away and like not make it flare up. And to like help like the hospital develop new ways of, like more medicine, like get more ideas of what’s happening and stuff.

Well, there were other options of drug trials I think, and there was loads of other medicines. But like they were injections. And I thought, Well, I want to do the trial because it’s like helping other people. And it’s like a better way of taking like medicine Because I don’t like injections.