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Clinical trials & medical research (young people)

Being invited to take part in a clinical trial: information and questions

Most young people we talked to were invited to take part in trials at their regular clinic appointments, or when they were staying in hospital.

 

Saskia received information about a trial at a routine clinic appointment, and because it was...

Saskia received information about a trial at a routine clinic appointment, and because it was...

Age at interview: 13
Sex: Female
Age at diagnosis: 11
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I went to a, when I went to one of my diabetic clinic routine check-up things, they asked me if I wanted to take part in it. And my mum said, “Yes, to help other people.”
 
And were you happy with that, mum saying, “Yes”?
 
Yes, it was all right, yes. It was good.
 
And who was it that actually asked you if you wanted to take part? Do you remember? Was it one of the nurses?
 
It was one of the nurses, yes.
 
And she explained everything to you? Did you understand everything when she was explaining?
 
Yes, I found it quite simple, just basically you just put a cross in each box.
 
And do you understand what, what it was about, what the clinical trial was about?
 
It was probably to help other children with diabetes, to help them if they were struggling a bit or something.
 
So in what way do you think it was helping them? Do you know?
 
Well, by filling in the booklet, these people can like do research in it and see if they can help them by doing their, by their research, and then people filling in booklets.
 
And was there anything that you didn’t understand at all?
 
Not really, no. I found it all pretty easy to understand. It was all quite easy, yes.
 
And did you feel there, there were, did you ask any questions at all? Did you want to ask?
 
I didn’t feel like I needed to ask any questions because I didn’t feel they were necessary to ask.

 

 

Joanna was in hospital when she was given information about a trial. It was a lot to take in at...

Joanna was in hospital when she was given information about a trial. It was a lot to take in at...

Age at interview: 17
Sex: Female
Age at diagnosis: 16
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So when did you get invited to take part in the clinical trial?
 
I think it was about a month or two after I’d been in hospital for my chemo. And they came, actually, no, sorry, I had to go in August for three days to get my first dose, and they came in and asked if I wanted to be part of the trial.
 
And how did it feel at that time? Did you understand what was happening when they asked you? And, because you’d not long been diagnosed and you were just having treatment, and then you’re asked to take part in something. I mean how did that sort of feel?
 
A bit overwhelmed, but like my mum suggested that would probably be best for me because they kept an eye on me, on my bones. Because they told me that I could have silent fractures and that. So I get regular bone scans of, and that.
 
What does a silent fracture mean?
 
I could fracture one of my bones and not know about it.
 
Would it not hurt?
 
No, it’s not meant to hurt. It’s just meant to happen and you’re not meant to know about it. It’s quite weird.
 
Have you ever had that?
 
No. I just keep on having my scans now and then, and it seems fine.
 
So when you were invited, were you in hospital at that time…
 
Yes.
 
…receiving some chemotherapy…
 
Yes.
 
…treatment already? So how long had you been in hospital?
 
I think they might have come in on either the second or the third day I was there.
 
Was it a nurse or consultant that asked you?
 
It was a nurse, I think. She was, she, I think she was involved in all the trial and that.
 
And how did they sort of, how did they invite you? When I say that, is,did they asked you and you said yes? Did they give you some information, explain things to you?

Yes, they explained about how it’s going to help in the future people who are going to be on steroids and everything. And it’s to see, it’s, whether it’ll strengthen your bones. Because with steroids it’s got a long, long-term side effect of brittle bones and everything. So this is trying to make my bones stronger, like to see if it does help my bones getting stronger.
 

 

Some of the young people we talked to heard about clinical trials through other means, such as adverts in journals, or by a letter from their GP, or school. Some heard about trials by email, and actively pursued taking part themselves rather than waiting to be asked. 

 

Katie and her mum responded to an advert in a science magazine. They emailed the researchers and...

Katie and her mum responded to an advert in a science magazine. They emailed the researchers and...

Age at interview: 13
Sex: Female
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So do you want to tell me how that came about and what happened?
 
I don’t know exactly but I think what happened was that my mum was finding out about it and my granddad sent mum an e-mail with the link to this news, this news finders magazine and it had about the trial in it. It was just ringing them up and finding out about it and that’s how I got on the trial.
 
So did your mum sort of enquire?
 
Yes.
 
Did she speak to you about it at the time?
 
Yes.
 
Yes.
 
Because she showed me the e-mail and the magazine.
 
So what kind of things did it say, what was it saying?
 
It was just saying that there’s this new medicine that’s going to help this type of medical condition because the medicine only helps with my particular type of CF which is G551D I think it’s called.
 
It’s got a number?
 
Yes I think it’s that.
 
Yes. And so were they, was it like an advertisement in a like in a magazine?
 
No it was an article about it.
 
Did you have, do you have to go, in the beginning when you first went you had an appointment with the consultant there, yes and was that the same consultant you see at the hospital where you were, no?
 
It’s a new consultant at the hospital there.
 
So it was a new consultant you haven’t met before?
 
I think it was a consultant.
 
Right yes okay. And he, did he explain?
 
She.
 
She explained things to you.
 
Yes.
 
And what sort of things did she tell you can you remember?
 
Just like explaining how I could drop out at anytime if I didn’t want to do it anymore if I was feeling, you know I could just finish any of the tests. So I could just, if I didn’t like any of the tests I could just drop out for a bit and then have another go at the test.
 
Was that reassuring for you, yes? And did they explain about any side effects to you at the time?
 
Yes they said one of them might be a bit of a rash and they said a couple of other ones. So it was quite reassuring knowing that if I was going to get something then I would know it was that, it wasn’t something else.
 
Okay so it was good to know that, the side effects, do you think it’s important that they told you about that.
 
Yes.
 
And did you have any questions at all?
 
I think they pretty much summed it all up in the information.
 
Was you quite concerned about anything at all?
 
No not really.
 
Did you then have to sign a form to say yes we agree to take part?
 
Yes once we knew I’d met, I’d matched the criteria we had to sign a form if I wanted to take part in it. And they just gave me an idea of what tests I’d have to do.

 

 

Will and his mum responded to an email asking for healthy children volunteers to take part in a...

Will and his mum responded to an email asking for healthy children volunteers to take part in a...

Age at interview: 12
Sex: Male
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Will' Well, first we had the email that, from the people asking if I would like to do it and we said yes.
 
Mum' And then you were asked to go to the children’s hospital.
 
Will' I was asked to go to the Children’s Hospital to have, nine, for a swine flu trial for the test of the vaccines. The first time I went, we had, I had a blood and a jab, and the second time we went, three weeks later, and I had just an injection. And then the last time, three weeks later, I just had a blood.
 
Tell me about the information that you had?
 
Will' They gave me some information on like what the injection was for. There was Buster, Baxter and Glaxo. And they asked you which one you were going to have and told you.
 
Did they, they told you which ones, but did they say, did you know which one you were going to have? Or did they say you won’t know which one you were going to have?
 
Will' They told me which one I was going to have.
 
Mum' I think there were two and they were randomly selected. That’s what happened.
 
And what was the vaccine for?
 
Will' Swine flu. Because it was quite a big outbreak at that time.
 
So the information told you all about what you had to do?
 
Will' Yes.
 
And did you understand all of the information?
 
Will' Yes.
 
Were there any questions that you wanted to ask?
 
Will' Not really, no.
 
Not really? Did they explain about any side effects at all?
 
Will' Yes.
 
How did they, how did they explain the side effects to you?
 
Mum' Like temperature.
 
Will' You could like get a temperature. You could have, come itchy or have a rash.
 
And were you, did that bother you at all?
 
Will' Not really, it didn’t.

 

A doctor, nurse, or other researcher should always give you information about what is involved, to help you decide whether to take part in a clinical trial. If you are aged 16 years and older you cannot enter a trial unless you have given your consent and signed a form to say you agree to take part. If you are under 16 years of age, you cannot give formal legal consent, this has to be given by a parent or guardian, but you should be involved in the decision as far as possible. In this case, you may be given an ‘assent’ form to sign. Assent means children give their permission or agreement to take part in trials. (See below for a fuller explanation of what assent means.)

It is important that you have enough information to give informed consent, or assent, and an opportunity to ask as many questions as you like.

 

Being able to ask questions reassured Hannah why she was being asked to take part.

Being able to ask questions reassured Hannah why she was being asked to take part.

Age at interview: 17
Sex: Female
Age at diagnosis: 4
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Well, I was just visiting the clinic like for my normal check-up. So just going to see the doctors and the nurses. And one of the, I think she’s a team management leader came round and spoke to me and asked me if I was, be interested in taking part in a survey to help the university find out more about like information that was given to diabetics, like new diabetics. And because I’ve had it for a long time, it, things will have changed since then, because I’ve had it for about fourteen years. So, so they just wanted to compare like different resources that you got given to help you with like your diet. And so I was, said that I was happily to do it. And then I had to fill out some forms then, like read through the, what we had to do and then fill out the forms.
 
So they gave you some, she gave you some information?
 
Yes, a package, yes. I had an envelope with all the information in.
 
And what did it, what, was the information nice and clear for you?
 
Yes, very clear. I did have to ask a few questions just to clarify exactly what it, because I get a bit confused, but just to make sure.
 
What sort of questions were you asking?
 
Just like why do they need to like, why do they definitely need to do it?
 
And did she answer?
 
Yes.
 
What was, what was, do you understand what they were doing?
 
She made me well aware of what I was doing and that I’d be helping a lot with the university and, yes.

 

You should also be given time to make a decision. (See also ‘Making the decision to take part and giving assent and consent’.) The UK Clinical Research Collaboration booklet on ‘Understanding Clinical Trials’ has a checklist of questions you might like to ask. You can print off the pages, which include spaces to jot down your own notes. 

To help you decide whether to take part or not, the researcher should explain'

The aim of the study – what it is trying to find out

How you will be treated and what you will need to do

What the possible risks and benefits are

You will also be given an information leaflet or ‘patient information sheet’ which you can take away and read. If you decide to take part, you will be asked to sign a consent form to say you agree to take part, or your parents/guardians will sign a consent form and you will sign an assent form.

Most young people we talked to felt they had been given very good, clear explanations and were able to make informed choices. They, or their parents, received written information and the doctors and nurses explained the purpose of the trial and what it involved. All the young people we talked to were reassured that they could withdraw from the trial at any time without affecting their care.

Kay was invited to take part in a randomised placebo controlled trial to test a new drug for cystic fibrosis and neither Kay nor the doctors and those treating her would know which drug she would be taking. She was impressed by how detailed the information was, including all possible known side effects and what to do if she experienced any. 

 

Not knowing which drug you are taking can be scary, but having good clear information to read and...

Not knowing which drug you are taking can be scary, but having good clear information to read and...

Age at interview: 23
Sex: Female
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And did you have a lot of information about it, was it written information?
 
Yeah, they usually provide kind of a pack quite a few A4 sheets of what is involved in the trial, how long it will be for, what they expect from you, what they will provide for you, and the purpose of them, of the of the trial, what information are they gaining from it and what kind of medical properties has that drug got. And all clearly explained so we had it written and we had a verbal explanation and it was all recorded in my medical notes. And obviously we’re told if we want to drop out at any time well we can and it won’t affect our standard of care if we do so.
 
And did it, what, you’ve explained about it being double blind and placebo can you tell me a little bit more about that and - because you didn’t know at the time?
 
No, to begin with they said, I think its one in four chance that it could not be the Mannitol drug. So one of them, so I think three would be the Mannitol, but they’d be different strengths and the one would be a placebo so it would be, it wouldn’t have any kind of clinical effect. So they said, you know, there is a possibility that you might not be on the drug but if you feel worse or you feel like you want to drop out at any time during the study, you’re more than, you know, you can. So I think if I felt that I was getting any worse I would have probably thought that I was, I was on the placebo, and I probably would have dropped out to be honest. But it’s quite a scary thing to think you’re trying something that you think is going to help but it might be a placebo but I suppose you need to take that risk sometimes if it’s going to improve your health.
 
And did it say about any side effects at all?
 
Yeah, it had contraindications for treatment and side, possible side effects. And obviously if I did have any side effects there was a diary that I could fill all these in or get in touch with the doctor or nurse at any time and then a decision would be made from there if to take me off the medication or to start new treatment so.

 

The doctors and nurses were always very helpful and supportive and this was very reassuring for young people. Many of the young people we talked to said how much they valued being able to talk face-to-face to a member of the research team and ask as many questions as they liked, as some of the written information can be quite complicated (see below). This helped them build trust with the staff. 

 

It was confusing with all the different treatment options, but being able to ask questions was...

It was confusing with all the different treatment options, but being able to ask questions was...

Age at interview: 16
Sex: Male
Age at diagnosis: 16
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I’ve been diagnosed with, with Hodgkin’s lymphoma in, in March. And I’ve had four lots of treatment. Going on to the fifth lot of treatment now for the clinical trial.
 
And when, was it March this year?
 
Yes.
 
March this year, you were diagnosed? And at what point did they invite you to take part in a trial?
 
It was after the first two treatments. That was after the first two months of treatment they invited me for a trial.
 
How did that feel at the time? Because it was quite soon, wasn’t it after…
 
It was a bit confusing. I didn’t know what, like whether to go on to the trial or not. But I decided to take the trial and get on with it.
 
What did you find confusing at the time?
 
Well, you could pick different treatments and find which one was be-, best for me and which was the best one to take.
 
So it was sort of deciphering what was the best way forward for you? Did, did they, was there, did they give you lots of information to read?
 
Made it helpful, easy.
 
Was it easy, was it easy for you to sort of read and understand?
 
Yes.
 
Was it a lot of information?
 
Yes. It was, like they highlighted the main bits. Which was helpful.
 
Did you have, what, did you have questions you wanted to ask them?
 
Yes, just like which, which, how often would I be in hospital, which one more, and which one, different treatments and stuff. So a few questions.
 
I think it’s quite important, isn’t it? Were they able to sort of ex-, answer all your questions? Did they sit and explain with you?
 
Yes. We spoke to the consultants and they explained about the different treatments.
 
How, how did they sort of go about that?
 
Well, we were in hospital one day. We just, mum organised to speak with the consultants and we just, she explained what like different treatment, like clinical trial, what would be normal
 
And did they explain the difference maybe between what, having the usual treatment or the treatment you would have had to being in a clinical trial? Did you understand what that was?
 
Yes, they explained that, they asked me to like, the, the clinical trial leaders first like, before like saying that, scan results and stuff like that and treatment.

 

Some of the young people we interviewed were invited to take part in trials soon after they were diagnosed. Being invited to take part in a trial at this time was overwhelming for some young people. 

 

When you are newly diagnosed with diabetes says Joe, being invited to take part in a trial can be...

When you are newly diagnosed with diabetes says Joe, being invited to take part in a trial can be...

Age at interview: 15
Sex: Male
Age at diagnosis: 15
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And how did that feel, you know, when you were diagnosed and then you were asked to go in to a trial? How did you feel at that time, because it must have been a bit overwhelming?
 
Yes, I was really overwhelmed, I was shocked. And my mum was shocked as well. And it was it was upsetting when I first found that out I had diabetes. But then I thought, “Well, it’s like, it’s a speed bump and not a stop sign. So it’s not going to stop me.” But then the trial, I just, I felt happy to be in the trial because it’s to help me and to help other people, research and stuff. So, yes, I was happy I got put in hospital though, because I was a bit shocked at the time.
 
And did you, what sort of questions did you have at the time?
 
I was really interested in like needles. And I was, because I love sport, sport’s a big part of my life, and I was worried in case I wouldn’t be able to play football and stuff anymore. So I was really interested in what I can do. And then I found out that the best thing to do is do sport, because it’s the best for you. It helps and stuff. But I was just; I was just worried about like, because I worry a lot, so I was worried about injections and stuff. I used to be scared of them. But then as soon as you have, like as soon as you go for the first like injections in the hospital, even if you are like really scared of needles, you just, you know, you get used to it. Because you’ve got to have it and… But, yes, but I was, I was worried about what would happen if, like just to me. And they explained that like if I take good care of myself I’ll be all right and stuff and nothing will happen. So that was good.

 

 

The doctors and nurses always answered any questions that Stephanie had about the trial. In fact...

The doctors and nurses always answered any questions that Stephanie had about the trial. In fact...

Age at interview: 18
Sex: Female
Age at diagnosis: 15
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So you say when you were invited, it was a consultant at the hospital that invited you?
 
Yes.
 
And did they speak to your mum and you together?
 
They spoke, they spoke to us, kind of they just told us about it. But any concerns I had really, because I stayed, because we live quite close to [hospital], literally like 30 minutes away on the train, mum, I would, I would say to my mum, she never stayed overnight with me because I thought, “You’re obviously so upset and so stressed. Just go home, sleep and come back in the morning. Because there’s no point in you staying here because you’re driving me crazy.” So any information I got was usually, because I was the oldest on the ward by about ten years, the nurses, you know, if they were up on nightshift would talk to me and, you know, if I wanted to cry about anything, it was them that I could speak to. Because the nurses there are just amazing. So any concerns I had they really explained to me. And any concerns about side effects, they would find information for me. And it was those kind of Yes, so just when you stay up at night and things play on your mind; I just had someone to talk to about it. And it was, I found that really helpful.
 
So the nurses, they were all good?
 
Yes.
 
And did you have any information yourself at all? Or was it all for your mum?
 
There was a clinical trial nurse and she gave me loads of like leaflets and was really good at kind of checking up on me, and gave me lots of numbers to call if there was like anything wrong and lots of people I could talk to at the hospital and offered counsellors, and almost given too much. I was just like, “Whoa.” But literally it was just take the pill every day and let it do its thing and just kind of carry on. There’s not much else you can do really.

 

In fact, many young people we spoke to said they would like information to be shorter, easier to read with simpler explanations, especially when there are complicated terms and procedures, and the use of pictures when appropriate. 

Ryan, aged 12, is taking part in a randomised placebo controlled drug trial. This is the first clinical trial he has taken part in. He says that the information he received was too difficult for him to understand because it used too many long words and he was too shy to ask questions. 

 

Ryan feels that trial information can be overwhelming and difficult to understand. Using bullet...

Ryan feels that trial information can be overwhelming and difficult to understand. Using bullet...

Age at interview: 12
Sex: Male
Age at diagnosis: 8
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Yes, I think I was in [the hospital] and then I was having the treatment but it weren’t working properly. So the, my doctor decided to put me on a new drug to try it out. And then he give me all these forms but I didn’t quite know it because there were like all long words in it. So mum kept that and try and read it to me.
 
I wondered if perhaps one of, the doctor or the nurse sat with you and explained things?
 
And that happened as well.
 
And did as well?
 
Yes. Because they just went over it to make sure I understood what was happening, what was going on with it and if I was happy with it happening.
 
And were you?
 
Yes
 
Did you have any questions at that time?
 
No. But once they told me about it I was a bit all right with it because, because, I, I think I was all right with it because it was better than having a needle every week.
 
Do you think there’s a better way of perhaps giving information to you about the trial?
 
Yes, because it wasn’t very easy for me to read, so I didn’t really get much of it. Because it, they were just using big, big long words I couldn’t really understand.
 
And you didn’t like to ask at the time?
 
No.
 
Is that because you, because it was all a bit too much and --
 
Yes, and there was a few doctors I didn’t know there and it just felt a bit weird.
 
Did it? But you, but you think they, if they made it sort of much more --
 
Easy to read, then I would have got it a bit.
 
Perhaps break it down into smaller?
 
Yes, because it was just a big sheet with just all writing on it. Just reading it was making my eyes go a bit.
 
Do you think they should do more pictures and things?
 
Yes.
 
More illustrations perhaps?
 
Yes. Try and break it down a bit.

 

 

Ryan was too shy to ask the doctors and nurses questions because he didn’t know them.

Ryan was too shy to ask the doctors and nurses questions because he didn’t know them.

Age at interview: 12
Sex: Male
Age at diagnosis: 8
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And did you have any questions then, once you’d been home and, did you have, you know, then have, go back and ask them any things?

No, because I was still a bit shy because I didn’t really know anyone. And it was just all quite new to me and that.

Was it a different hospital than one you normally, the one you normally go to?

No, but it’s a different place in the hospital. [Mum' And a different nurse.]


So you didn’t know all of these nurses and doctors? They were all new…

Yes.

…to you? Did that worry you at all? Did that, was that a bit scary?


Yes. Just talking to people I didn’t really know. And it was just a bit weird that they knew a lot about me, and I didn’t know anything about them.

Do you think, do you think you’d like to have known a bit more about them?

Yes.

Yes, I think I would too, yes, especially when they know so much about you.

Yes.

What sort of things do you think, if that was another young person, what do you think they can do to improve that and make it, like giving the young person information about who the doctors are?

Yes. Because I didn’t even know any of their names.

Didn’t you?

No.

Did they introduce themselves to you when --

Yes, it, like it, the second time I went they introduced themselves, but not the first time. So I was a bit shy.
 

Joe says that trial information needs to be more ‘child friendly’ when explaining medical terms...

Joe says that trial information needs to be more ‘child friendly’ when explaining medical terms...

Age at interview: 15
Sex: Male
Age at diagnosis: 15
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Could that have been improved in any way?
 
Joe' I think sometimes they could have made it more like, you know, like not as, how can I explain it?
 
Mum' Child friendly…
 
Joe' Child friendly.
 
Mum' …reading.
 
Joe' …more to read. Because some of it I didn’t understand when it was like saying about the, the different types of insulin and stuff. And I was getting really nervous about that because I was just thinking, “Oh, I’m going to get it mixed up.” But I think if they just like explain it like in a different, like word it differently sometimes, I think it could help a lot.
 
So a bit more simplistic.
 
Yes, simplistic, yes.

 

It is important that trial information tells you what you want to know about the study. It may contain a lot of medical terms. Alexander, aged 18, was invited to take part in a randomised placebo controlled trial to test a new drug for arthritis. The information he was given contained a lot of medical jargon that was difficult to understand.  

 

Even though researchers do their best to make trial information easy to read, Alexander feels...

Even though researchers do their best to make trial information easy to read, Alexander feels...

Age at interview: 18
Sex: Male
Age at diagnosis: 16
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And when you had all the information, you had the information given to you at the hospital to read?
 
Yes, they gave me most of it at the hospital and then some of it they sent over. It was a vast amount of information. It was, it was mainly medical, where someone who hasn’t had a training, doesn’t have the knowledge, wouldn’t really understand. But I think by law or some weird kind of thing they have to give it to you. So most of it, I didn’t understand a word of. But some of it you could see someone was trying to work it out and make it, explain to normal people, but it still was quite hard to understand what was going on at the very early stages.
 
Well, that, so it was quite difficult to grasp it all?
 
Yes.
 
And when you say there was a lot of information, was it like booklets and…?
 
It was booklets and files and, you name it, we probably got it given here somewhere.

 

 

Alexander also feels that Information about trial drugs can be confusing and also worrying,...

Alexander also feels that Information about trial drugs can be confusing and also worrying,...

Age at interview: 18
Sex: Male
Age at diagnosis: 16
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And when you say, so that all happened, so soon after that all happened and they gave you the diagnosis, you were invited to take part in the trial?
 
Yes, I was.
 
How did that feel at the time?
 
At first it was quite disturb-, well, not disturbing, quite worrying, thinking, “Okay, I’m on a drug trial. It’s a new drug. It’s obviously being used on other people, but they’re using it on young people where this medication is made for.” It’s to see what happens and experience what happens and just to see if any more information they can gather, gather about it.
 
And what information did you have about the trial?
 
At first, not really a lot. They said straight away in the information they gave me, “There is a possibility of cancer.” But that’s, from what I’ve read up over the information, that, in every trial that seems to be there. And the other one, it’s knocked out my immune system. But apart from that there wasn’t much information. It did seem to kind of loop over itself. It didn’t really explain much. It was just a lot of medical jargon again.
 
What sort of jargon?
 
Things I’ve never heard of. Or it did, as I’ve probably just said a minute ago, it kind of circulated over each other. It constantly repeated itself about information. They didn’t really know but they tried to explain it as well as they could. The cancer, I was, I was worried about probably the most. However I got told by quite a lot of people not to be worried about it as it is quite a common thing to say in all kind of information they’ll give you. That was the most information I kind of really got. It was saying what the drug was for, what the drug is made out of, what, I’m no chemist or doctor, so I don’t really need to know about that information. So apart from that, not much I could tell you. It told me about the proteins in my blood. However I already know that from my other doctors. Saying how it would attack this other protein and hopefully bring it down to a level. And that was basically it.
 
And when you say other people were telling you about, “Oh, well, cancer and that is always mentioned, and side effects for these things” who, was it the doctors that were telling you that?
 
The doctors and actually other people, people who haven’t actually been on drug trials. Just like general public, I guess, saying, “Oh, they’ll say that in pretty much everything.” And things I read on the Net. The doctors said that mainly though. Because, and I did actually trust them more than the site, the doctors.
 
Did they say what type of cancer?
 
No, they didn’t actually say. So that’s a bit on the interesting, well, worrying side, saying “We don’t actually know what cancer, if any.” And that’s probably the worst bit in my opinion at the beginning of the trial.

 

When Stephanie was invited to take part in a trial there was little known about the trial drug in the treatment of Wegener’s granulomatosis, a rare condition in young people. She had lots of questions about side effects and also searched the internet.

 

Stephanie didn’t want to know about the biology of it all, she wanted to know more about the side...

Stephanie didn’t want to know about the biology of it all, she wanted to know more about the side...

Age at interview: 18
Sex: Female
Age at diagnosis: 15
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Did you find there was too much information?
 
I think there was too much of the wrong information. It felt like, I wish I’d been told more about the side effects because that’s what you really care about. Like I don’t, I’m not going to understand the biology of it all and what exactly it’s doing. And so I don’t really, I don’t want to know about that. So I just take it and it does what it does. If it works it works, if it doesn’t it doesn’t. But it’s what is going to affect me every single day is what I want to know. Like they didn’t know a lot about fertility. They didn’t know a lot about hair loss. They didn’t know a lot about kind of brittle bones. They were like, “Take calcium. It might make you have really brittle bones.” And, you know, I think the thing is, is because it was a clinical trial they couldn’t give me a lot of definitive answers about the long term. Which is what I was worried about. Like, “If I lose my hair, is it going to grow back?” If, I mean I didn’t have a period for like a year and a half. I was like, “If they stop, are, are they going to come back? Am I going to be able to have kids in twenty, thirty years if I want to?” You know, “Is, one day is my, you know, thigh bone just going to crack and there’s nothing I can do about it because my bones are so brittle?” So I think that was s-, something I did get quite frustrated about is that, you know, they kind, they try and downplay anything that they think might deter you from taking it, just because they want you to take it and they want you to get better. But it’s the kind of things that I want to know because it will affect me. Like the cutting and the scarring and the bruising really easily, those are the things that are going to affect me every day. So those, those were the things that I would want to know, and they weren’t really shared with me. Just because, I think maybe they just didn’t know because no one had, you know, it was a clinical trial.
 
When you say they downplayed and they didn’t share it with you, what made you think that?
 
Because the side effects were like, you know, severe enough. Like if I got cut by my cat or something, it would take it two or three days to stop bleeding. And I would have thought that something like that I mean they would share with you. Because if it wasn’t just a cut by my cat, but I got hit by a car, you know, that’s something that maybe I should know. Maybe someone like a paramedic would want to know that kind of information. But I don’t, maybe it’s not downplaying, they just, maybe they just, they don’t know. So that was what I shared with them in the feedback, a lot of that.

 

 

Because little was known about the trial drug Stephanie looked on the internet. It was reassuring...

Because little was known about the trial drug Stephanie looked on the internet. It was reassuring...

Age at interview: 18
Sex: Female
Age at diagnosis: 15
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I mean did you ask questions at the time?
 
I did. But there weren’t that many questions that I had. They were all about the side effects and a lot of them they couldn’t really answer. And I had to just find out by myself in time.
 
And how did, you say you had to look it up and, and search on the Internet, what places did you look for and how did you find…?
 
Just, I just Googled it and I mean there wasn’t a, there was literally nothing on treating Wegener’s with it. There was a lot about kind of what it’s mainly used for, which is transplant patients and stopping them from rejecting organs, and they sometimes use it after big blood transfusions. Yes, so there wasn’t a lot of information about treating Wegener’s with it because it’s still in a clinical trial. But what I could find, you know, kind of reassured me that it was legit and I wasn’t just being given some random drug that no one had ever heard of.
 
So the drug had, was known sort of thing? What made you sort of feel a bit more assured on seeing the information?
 
Just that there was, there was a lot of information about it. And reading people who’d had like kidney transplants and everything, you know. It was much more, I don’t know, it just reassured me a bit that lots of people had good things to say about it and had a high success rate with it.

 

Some of the younger people we interviewed felt that they should receive the information before, or, at the same time as their parents.

 

Mohini thought it was a bit unfair that her parents got all the information first.

Mohini thought it was a bit unfair that her parents got all the information first.

Age at interview: 12
Sex: Female
Age at diagnosis: 9
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I was diagnosed with acute lymphoblastic leukaemia on the 21 August 2007, yes and I mean as soon as I was diagnosed my parents were given these papers to sign saying that they are willing to consider taking part in a trial. I didn’t know anything about it at the time, so that’s basically when my parents found out about it. And I found out about it when I was just about to start my intensification blocks, so there’s two intensification blocks because...
 
What are those what’s intensification?
 
It’s where so basically the treatment is set out that you have, you have sort of chemo every week for quite a while and then you have a bit of a break and then you go back on and then I think about a quarter of a way into your treatment you have two, I think it’s seven or nine neat blocks where it’s a lot of chemo like you’ll be on weekly chemo, daily chemo then you’ll be on six hour infusion chemo. So it’s a lot of chemo so that’s the main thing that kills everything and basically the rest of the treatment after that is just to prevent it coming back. So the study they were actually doing was because in Europe they don’t actually do two blocks they do one, so they were running a study were you were randomised, if you said yes, you were randomised to either have one block or two. I, well yes, I decided against going in the trial. My dad thought I should go in the trial but the way I saw it and the way my mum saw it is that if I have two blocks it’s less chance of it coming back, it’s basically having an extra nine weeks intense chemo or doing it for years later on, basically. I didn’t get that much information on the trial, I went, because I was quite mature as it was but once you get, you get an illness you sort of mature straight away. So I pretty much read my parents information with a bit of help but I didn’t really, as far as I remember I didn’t get any information.
 
Oh didn’t you?
 
I don’t really remember.
 
So it was your parents?
 
My parents got the information as soon as I was diagnosed and they were told to read it which I think was a bit unfair. But then when, I mean it was more my consultant explained it to me and my parents explained it to me and what was at risk and what they were trying to do and then from that my parents and I just sat down and discussed it and we made a decision, basically.

 

 

She says young people can understand complex information and doctors shouldn’t underestimate...

She says young people can understand complex information and doctors shouldn’t underestimate...

Age at interview: 12
Sex: Female
Age at diagnosis: 9
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So you say you don’t remember having any information that was given for you?

I don’t remember I might have done it might be worth asking my mum that one because I remember when I was first diagnosed they gave me these books like John had leukaemia and what leukaemia was but I don’t remember receiving any information about the trial.
 
Would you have liked to have some information?
 
Yes I would have. I might have done but I don’t remember, I’ve blocked out quite a bit of that, I wouldn’t say I’ve blocked out but I don’t remember it all, if you know what I mean.
 
Well it’s a lot to take in isn’t it?
 
Yes definitely.
 
I mean when they approached you to take part in the trial did they actually approach, was it your mum that they first spoke to or was it to you?
 
My parents, I didn’t know anything about it until my consultant spoke to me about it, I didn’t know a thing.
 
But were you in the room with them at the time?
 
No.
 
No.
 
They took my parents to one side and asked them.
 
Okay and then your parents, who told you first?
 
My consultant.
 
Right, so he saw you after?
 
My consultant discussed it with me, so he gave me like quite a while before my block and then like every time, we’d sort of discuss it every time I went to see him and then I think we just sort of came to the conclusion. And I think it was really good my parents, because my parents let me decide, they didn’t see it as it was their decision not mine. They realised that I was mature enough and it was my life I was playing with and that I should be able to make that decision.
 
Do you think that’s important as well?
 
Yes I mean parents as well as doctors have to understand that when a child gets a serious illness they’re not children anymore. They’re almost adults in the way they think and the way they do things. And they have to understand that it’s their lives that they’re playing with not their parents, not theirs but the child’s life and they have to be able to make the final call no matter what age. It should be their decision, if they’re old enough to understand then why should they not be allowed to make the decision. I agree with things like consent, a parent to consent but I think that children should also have to give consent as well.

 

Some of the young people we interviewed said they didn’t have any questions about the trial because they felt that everything had been explained to them and they couldn’t remember much about the information or what questions they had asked because it was quite a long time ago that they took part. However, like Stephanie above, possible side effects on fertility was an issue for a number of young people taking part in drug trials. 

 

Alexander had some unanswered questions, including how the trial drug might affect his fertility,...

Alexander had some unanswered questions, including how the trial drug might affect his fertility,...

Age at interview: 18
Sex: Male
Age at diagnosis: 16
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And did you have questions to ask?

Well, main, my main question was, “Will I get better?” and, “Will it improve my lifestyle?” And another question was mainly looking at the future, not right now, but, “If I ever wanted kids, will this drug damage them?” As there are so many other drugs for arthritis and many, loads of drugs like that, where you can’t have children while you’re on them, or, “Does it damage me in any way later in life?” for where I can’t have kids and so on.

Because I think also you mentioned just beforehand, is the having the children was a worry, but also your career?

Yes, it was quite weird thinking, “Okay, I have to be in hospital quite often. So my career I want to go in to, it has to be quite a long base, quite an ongoing thing.” So you have to kind of work around the drug. So that’s a bit of a problem in my opinion, but I think eventually you could work around it.

Yes, those were the main problems in my opinion.

And they answered those questions for you?

They tried to as best as they could. It wasn’t something they actually had to think about, as they were in a children’s hospital and 4-year-olds don’t have to worry about that kind of things. So they had to look themselves, they had to ask around, because it wasn’t a normal question. So that’s something what was a bit, kind of a bit shocking really, to hear doctors looking for things they didn’t know. But I hope, I think they kind of reassured me, saying, “Well, we don’t think this is going to happen. We don’t think your illness is genetic. So it doesn’t carry on. So we don’t really know, but we think it’s not.” So that was okay. I pray for the best really.

I suppose, because that was one of the things you were concerned about, wasn’t it? Is that, it’s just not having the children; it’s whether you can pass anything on.

-- pass on, anything on, or if the drug will damage them. As there are cases with normal rheumatoid arthritis where their medication will damage the child.

But you felt, did you feel reassured?

I felt reassured if the doctors felt in that way. Because they didn’t know because it’s a new kind of question and they don’t have to think about that them, themselves. And they haven‘t, they’ve never had to answer that kind of question before. So I’m just kind of hoping for the best on that one really.
 

A few young people said they might have liked to understand more about the trial, but at the time it wasn’t the most important thing they were worrying about. 

 

Ethan remembers being informed about the trial but he can’t remember any of it, he just wanted to...

Ethan remembers being informed about the trial but he can’t remember any of it, he just wanted to...

Age at interview: 12
Sex: Male
Age at diagnosis: 11
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And at what point were you invited to the clinical trial?
 
I don’t know, I can’t really remember it that well bit I think it was about January.
 
Was it?
 
Yes.
 
Was it when you were in hospital?
 
I don’t know I think so.
 
What happened, what did you know about it?
 
I don’t know they spoke to my mum and dad quite a lot so I didn’t know what was going on.
 
Ah okay.
 
It would be one day you’re going up this hospital then you’re going up the other so it was all quite a shock to me.
 
Was it?
 
Yes.
 
Did they talk to you about it about what you were going to do?
 
Yes they, well they did like talk to my mum but they said they’d talk to me more because I was the one that was actually going through with it, so yes.
 
Do you remember anything that they told you at the time when they talked to you?
 
Not really.
 
No?
 
No.
 
It’s all gone now hasn’t it?
 
Yes.
 
It’s in the past.
 
Yes I kept having like loads of visitors telling me all this stuff like doctors but I can’t remember any of it really.
 
And when you took part in, you say you took part in a clinical trial, do you know what the trial was about or what the purpose was?
 
No.
 
Do you think you would like to have known?
 
Yes.
 
Did you think to ask anybody or not at the time?
 
Not at the time no.
 
Why was that?
 
I don’t know really, I just didn’t really think about it I just wanted to get like, you know, get better and that.

 

In addition to having written information about the trial some young people had a video to watch. Jenna, aged 13, was invited to take part in a randomised placebo controlled trial. She was pleased to have her own written information and a video that explained about the trial. Researchers may want to consider using a video or other similar technology. (See ‘Young people’s messages to health professionals’.)

 

Having a video to help explain a trial and what it involved was really helpful. Jenna said it was...

Having a video to help explain a trial and what it involved was really helpful. Jenna said it was...

Age at interview: 13
Sex: Female
Age at diagnosis: 11
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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.

 

Explaining assent

Assent means children give their permission or agreement to take part in trials. To give assent children need to understand the research process and be informed about what they are expected to do. All children have the right to receive information given to them in a way that they can understand, and to consider assenting, or not (to say they agree to take part, or not). In deciding whether to give assent, children can express their views and any worries about taking part. Doctors need to listen to the opinions and wishes of children who are unable to give full consent, and do their best to help them. Consent from parents and assent from children are both needed for children under the age of 16 to take part in clinical trials. 

If English is not your first language, the trial should be explained to you in your preferred language and you should be given a consent form in that language.) 

 

Helena, a health professional, explains what happens when English is not the first language.

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Helena, a health professional, explains what happens when English is not the first language.

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And what do you do when maybe as you said it isn’t their first language?

It depends really, for some studies the patient information leaflets are translated into different languages. But for example here in [hospital], I can’t remember the number, but I think there’s something like 150 different written and spoken languages. So which language do you choose is always the question? For diseases and studies where it, certain languages are spoken, or for certain ethnic minorities you could sort of pick one or two. And for some of the bigger commercial sponsors, so drug companies, they would if you had a potential patient who spoke a certain language they would pay for that information to be translated but it is quite an expensive thing to do. And apparently they, it has to be back translated so the information sheet has to go to translation services to translate it and then send it on to somebody else who back translates it and it has to be identical. And then the ethics committee obviously don’t necessarily speak the language so they give approval on a sort of certificate of approval. We would try and use, always try and use translation services within the hospital link workers which most hospitals have. But it’s generally not appropriate to get a family member to translate because we can’t, not that we don’t believe them, but we can’t be sure of what they’ve actually told them and that they’ve covered all the key points unless we understand that language ourselves. So generally we wouldn’t take family members translating for us, we would chose to pay for a translator within the trust.
 


Last reviewed March 2017.
 

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