Clinical trials & medical research (young people)
Withdrawing from a trial
It is important that young people know they are free to leave a trial at any time and without giving a reason. It may help them feel more confident to take part in the first place, if they know they can always drop out. Young people we talked to remembered that this was made clear to them and they never felt any pressure to continue.
One young person we talked to decided to withdraw from a trial. Courtney, aged 12 years, took part in a trial involving growth hormone treatment when she was aged six, but she disliked having daily injections, and after five years withdrew from the trial. She would consider other similar trials in the future and thinks it is good young people take part in trials to help others with similar conditions.
Having injections and starting high school were some of the reasons that Courtney decided to withdraw from the trial.
Having injections and starting high school were some of the reasons that Courtney decided to withdraw from the trial.
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But you were at you were at school at the time?
I think I was in primary school when I took them.
In primary school. And why did you decide not to take them anymore?
Because I, I was going to High School and that like I was fed up taking them.
So you were fed up taking them. Do you think they’ve helped you?
Yeah a little bit, but when I, when I used to take them, they, they, they, I was like, they stopped me growing, but they didn’t. But that’s, I feel like I’m growing better than when I took them.
You feel like you’re growing better without them?
Yeah.
So you’re not sure that they’ve quite helped you, or, do you think that was just...?
They were alight but I prefer it when I didn’t take them.
Why is that?
Because, I don’t know.
It makes you feel better not having to take injections does it? Or,
Yeah.
And did you, when you say your friends and that... Did you talk to your friends about what you were doing and...?
Not from the start when they had to like, showed me, I told them like when I was like in primary school, and they kept telling people, and I was like, “Oh, don’t tell people.”
And that put you off a bit did it? How did it make you feel that they were telling other people?
Really angry.
Did it? And what did you do with your anger?
Just calmed down.
Courtney got upset each time she had to have her growth hormone injections. Having the trial medication as a liquid would have been better.
Courtney got upset each time she had to have her growth hormone injections. Having the trial medication as a liquid would have been better.
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Is there anything that you’d like to say about your own experience? If you could sum up all your experience, how would you say it’s been? Just going to the hospital for tests and having injections?
Courtney' I hated going to hospital.
Did you?
Courtney' Because the needle and all that.
Was that the only thing, it was just the needles? That’s the main thing that you didn’t like and, and that made it quite hard for you. If it had been another way or having the growth hormones, if it had been in liquid form, or...?
Courtney' Yeah, it would be, it would be actually better if it was liquid.
Would it - you would prefer that?
Courtney' Instead of a needle.
And would you, if, if it had been in another form than a needle for you, do you think you may have stayed, continued taking them?
Courtney' Yeah.
So it’s really a thing about needles isn’t it? Like you didn’t like having the blood tests? Are there any other tests that you didn’t like or you had to have?
Courtney' No.
It’s just those.
Courtney' It’s just the needle.
It’s just the needle.
Mum' Carrying all the back up.
Courtney' And I hated going, I hated, I hated to go to the hospital.
Did you? Why is that?
Courtney' Because it’s a long journey, plus the needles and all that stuff.
Mum' But they looked after us.
Yeah.
Courtney' Yeah.
They were nice when you were there. But it was just the, was it a long journey because you didn’t want to go? You know, was it the thought of having needles and it worried you. Did it worry you at all?
Courtney' Yeah.
Did you get upset?
Mum' I think that’s why she, well she got herself all worked up, and then obviously having this faint.
Sometimes being part of a trial involves quite a time commitment, for example, attending extra appointments, travelling to and from hospital, taking time off school, or spending time being interviewed or completing questionnaires.
Some young people talked about thinking whether they should withdraw but then deciding to continue - for various reasons.
Robert had considered withdrawing because the intervention was unpleasant, but knowing it was going to help him and others with cystic fibrosis gave him the motivation to continue.
Robert had considered withdrawing because the intervention was unpleasant, but knowing it was going to help him and others with cystic fibrosis gave him the motivation to continue.
Sex: Male
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Well I’ll answer the first with respect of the leg rash that was actually, interestingly I had a very last appointment with them that day and then the rash turned up in the evening. So technically I had finished the trial by that point when the side effects happened. But with the losing my voice, I did wonder do I want to put myself through another bronchospcopy. And then I think I possibly took the approach of well it can’t do any more damage than it’s already done so I may as well carry on and I’ve got this far. And there was also because on the pilot study it wasn’t double blind because that was a sort of Phase 1/ Phase2 trial. So it was on a small cohort but we all knew we were definitely having the gene therapy. And so to have the opportunity to have a dose of gene therapy was, you know, even if it might not work, its full effect is still well it’s exciting scientifically but also a great opportunity medically for myself to get that.
So is that a personal benefit for you?
Yes I think so and also if so if on the multi dose trial, you know, if everything goes well and then it all progresses and your through to the end then by being someone that’s taken part in the trial you will then have preference to be on the drug once it’s finally finished and released. And so that, that’s always the benefit you can hope for as well.
Is that an incentive or motivation to take part, personal?
I think it is partly yes. Yes as I say as far as this gene therapy trial I think it’s partly being what I said earlier about wanting to give back and contribute for future generations but then also partly the chance to end up being on gene therapy from the very beginning, you know. As soon as I can and yes.
Alexander was concerned about the side effects of the trial drug, but also about missing school and his exams.
Alexander sometimes thinks about dropping out because of unpleasant side effects of the trial drug, but he knows withdrawing from a trial is an important decision, and not to be taken lightly.
Alexander sometimes thinks about dropping out because of unpleasant side effects of the trial drug, but he knows withdrawing from a trial is an important decision, and not to be taken lightly.
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And I mean did they mention about withdrawing, that you could withdraw?
They say you can withdraw, but it’s very hard to because they don’t want to let you out really.
Sometimes they will give you really good points for not coming out of it, “Okay, well, do you really want to come out of it while your exams are going on? Because you’ll have to look for more medication.” But sometimes it’s just, no, you don’t want it. “Okay, is there any reason?” “No.” “Okay.” So you just kind of sit there and kind of work out well what’s your best opinion.
So it gives that option, but they’re not keen on you….
Yes, well, I think that’s just kind of they put so much time and effort and money in to you, they don’t want to lose a good resource.
And have you thought about withdrawing?
I’ve thought about it a few times, just due to kind of getting annoyed or frustrated with some of the like side effects like the sleep withdrawal or the kind of skin or any of those kind of things. You just kind of think, “I’m sick and tired of this now. I just want to be normal. I can’t be arsed with chest infections or any of that kind of stuff anymore.” But then you think about it properly and go, “Well, what happens if I do come off it? Am I going to get really bad or even worse than I was? Or what happens?”
If you want to come out of a drug trial you really really have to think about it. It’s not just kind of one of those split-second things, thoughts about it. So, I don’t know.
Joanna was worried that forgetting to take her medication would affect the trial results and considered withdrawing, but she continued because she knew her condition would be closely monitored.
Joanna was worried that forgetting to take her medication would affect the trial results and considered withdrawing, but she continued because she knew her condition would be closely monitored.
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Have you ever thought about withdrawing at all or stopping when it got complicated or –
Yes. Yes, I’ve said to my mum, “I think I should just…” Because I missed, when I missed them I thought, “It’s just going to affect the trial, and I don’t want to ruin it in case it does come out that I have got the actual, real drug, medication.” But she was just like, “Well, I’ll help you remember.” Because she wants it to keep an eye on me with my bones and everything as well as that.
Is that, is that your mum wanted you to stay in?
Yes.
And I know you said taking part, going back to that, just sort of the reasons, this, this interest in, do you think by taking part they will keep a, more of an eye on you?
Yes, they have done. They even said that, “Being in this trial, we’ll keep an eye on you more.” And some of the doctors said they will keep an eye on you more. Because they’re going to be examining my bones. And I wouldn’t know, with this medication I wouldn’t know if I had a silent fracture and the doctors wouldn’t know. So it just, that was one of the reasons. And some of the side effects, there’s like muscle weakness and that, so they could probably just help with stuff like that.
For some young people, taking part in a trial means giving your full commitment, but having the option to withdraw is reassuring. (See also ‘Being invited to take part in a trial: information and questions’ and ‘Deciding not to take part although eligible to take part in a trial’.)
It was reassuring for Lauren to know that if she chose to withdraw all her information would be destroyed, but she would still be able to take part in future trials if the opportunities arise.
It was reassuring for Lauren to know that if she chose to withdraw all her information would be destroyed, but she would still be able to take part in future trials if the opportunities arise.
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Do you think it’s important they offer you that option to withdraw?
Yes, yes. Although to me, if I withdraw something, I know I haven’t given it my full, and that if I did withdraw, I knew that I weren’t fully committed in the first place. So when I think things through, and even though they give me that option, I prefer to think things through and make sure that if I do it, I will go to the end and do it. I don’t want to do it halfway and give up. So I’m doing it all the way.
It’s good, and they’re good reasons as well, you know, what you say. But I think a lot of young people need to know that you can opt out. It’s just a…
Yes.
…reassurance, isn’t it? Really that you don’t have to do it.
Yes, I like that.
Did they offer you, you know, when they say you can opt out, did they offer you, say, “Well, if you did come out, we’d still treat you”?
No, I think it was more of a case of if I opt out then they’ll destroy my files and everything that I’ve put in, and I think they’d send us a few things about the trial later on. But that was about it, I think. I would have been totally pulled out of that trial. And they said that if, in future if they had any more they would contact me, but then they, but my, all my files and that would be destroyed and everything. But I think that was about it really.
If you experience side effects you may have to withdraw – your health is always the top priority
Because of an infection, Katie was advised to stop the trial. She didn't want to, but knew it was for the best and may be able to rejoin the trial when she is better.
Because of an infection, Katie was advised to stop the trial. She didn't want to, but knew it was for the best and may be able to rejoin the trial when she is better.
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Did you have to stop the trial at all?
I had to stop the trial for a bit because the IV’s interfere with how well I am.
Okay, what’s the IV, do you want to explain?
It’s intravenous which is basically where they put a tube into your vein and the medicine goes straight into your veins instead of having to digest it all. So it goes straight into your system and its stuff that can’t be taken orally.
So did you have to stop, you had to stop all the other, the trial?
The trial medicine, yes. Because I was on wash out month and I just went downhill a bit, I don’t know, I think it’s because of the summer all the tree spores and hay fever and everything.
Oh yes, you think that, do you normally get that?
Yes it’s usually in the summer.
Is it?
And worse.
So that, did that bother you at all?
A bit but I can go back on it.
What did they say at the hospital when that happened?
Which hospital, the trial?
The trial hospital yes.
They just said that you can go on IV’s and you have to be clear of everything for six weeks and then you can come back. But now I’ve got to have a camera in my lungs, I’ve forgotten what it’s called.
Bronchoscopy is it?
Yes I’ve got to have that. It’s either at the end of this week or the beginning of next week. So that’s and then I have to go on IVs straight after so that’s been put back again and IV’s every six months.
Yes, but have they said that you can stay in the trial?
We’re just going to see how it goes.
Right okay, so at the moment you’ve had to come off the trial?
For a bit.
For a bit yes, how do you feel about that?
I feel alright, I‘ve just got used to being off the trial for a bit now. So we’re just going to see how it goes and see if there’s any point going back on it. I probably will but we don’t know yet.
And what have they said at the trial hospital, did they say?
They said that if there’s a clinic, a clinical problem just stop the trial, get better and in six weeks being clear of everything.
And then you can re start?
Yes do the same thing.
Does that kind of, does that feel good that you can?
Yes it feels nice like I can restart it at some point.
And will you do you think, do you think you will if things are okay?
Yes if I can I will, definitely.
Dr William van’t Hoff, and Helena, a health professional, explain some of the issues around consent and assent for young people when they are aged 15 years and younger and 16 years and over.
It is important families understand how clinical care and research fit together. The process of consent and assent is an ongoing process and not just a one-off 'yes' at the start of the trial says Dr William van't Hoff.
It is important families understand how clinical care and research fit together. The process of consent and assent is an ongoing process and not just a one-off 'yes' at the start of the trial says Dr William van't Hoff.
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In clinical trials for adults, the adult gives consent to take part. But for children taking part in studies the situation is very different, because the consent is given by an adult parent or carer who is not themselves the person who is going to undergo the trial and the benefits and the risks. So the situation is different. And researchers need to explain that carefully to families to under- to ensure that they understand that. Of course parents and carers consent for their child’s care in general, and this process of consent is similar for research. But it’s important that they receive and understand carefully the written or other information that’s provided to them, so they’re clear which parts of the care are research and which parts are part of routine care. Older children who understand what is being suggested can also take part in the process of agreeing for research. We call this assent, and it’s a process whereby a child gives a positive response about taking part in research. And this concept of assent varies actually from different countries. Some countries don’t even recognise it. And the age at which assent is appropriate varies from country to country. But in general terms, assent is something, is a process that should be sought by a researcher in a child who has a, an understanding of the research process. It’s also important to recognise that this process of consent and assent is an ongoing process. It’s not just a one-off ‘yes’ at the time of signing a piece of paper. It’s ongoing through the study and can be withdrawn at any stage, and researchers will respect that.
Helena explains the age at which children can give assent and consent and what may happen when there is a difference of opinion between young people and their parents.
Helena explains the age at which children can give assent and consent and what may happen when there is a difference of opinion between young people and their parents.
Sex: Female
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At what age can, what age do children assent to take part?
For some studies information sheets produced from children from three which are three to five which are basically pictures. And if you’ve given information sheet there’s a lot of the sponsors who are running the studies like the children to give their assent. So they like them to say yes okay I’ll do this. It’s debatable at what age is appropriate and that’s something that varies from people to people and from researchers to researchers. But obviously fifteen year old knows their mind and as long as they’re given the right information you will always get assent from them but because it’s a clinical trial you wouldn’t be able to give consent you would still need to speak to the parents. And then if there’s a difference of opinion that’s something that needs to be discussed locally and decided on whether you’re going to put that patient in the study or not.
So sort of aged sixteen and over, under sixteen they still have to have, even if they agree, they’ve still got to have parental consent?
Yes, until the child's sixteenth birthday, if it’s a clinical trial of a drug, the clinical trials regulations state that parents give consent and if the child is aware enough about the study and are able to we would take assent from them, once they’ve been given all the information as well.
See our resources section for more information.
(See also ‘Making the decision to take part and giving assent and consent’.)
(See also ‘Making the decision to take part and giving assent and consent’.)
Last reviewed March 2017.
Last updated July 2014.
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