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Clinical trials: Parents’ experiences

Withdrawing your child from a trial

It is important to know that you can withdraw your child from a trial at any point, without giving a reason, and without it affecting your child’s care. Parents we talked to remembered that this was made clear to them and they never felt any pressure to continue. The reasons for withdrawing included the time and demands of the trial, uncomfortable procedures and tests, and their children’s requests to stop. Sometimes being part of a trial involves quite a time commitment, for example, attending extra appointments, travelling to and from hospital, taking time off work, or spending time being interviewed or completing questionnaires (see ‘What is involved: time commitment, costs and payment’ and ‘What is involved: appointments and monitoring’).
 
The majority of parents we talked to felt it was important to respect children's wishes to withdraw from a trial. (See also ‘Involving children in decisions’.)
 
The length of a trial can vary from a single day to weeks, months and even years. Two parents we interviewed withdrew their children from a trial. Both children had taken part in a randomised trial on growth hormones. For one parent the decision to withdraw was at her daughter’s request. She had taken part for five years and just felt it was time to stop.
 

It was their daughter’s decision to withdraw from a growth hormone trial.

It was their daughter’s decision to withdraw from a growth hormone trial.

Age at interview: 36
Sex: Female
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 And did you ever consider withdrawing at all?

 
No. No.
 
All throughout all that time?
 
Yeah. Definitely we kept her on them.
 
I think it’s a two or three, three years like you can go on it for three years and if you want to carry on you can do and that. But we done it for five years, and Courtney like said no.
 
So you did your three years?
 
Yeah.
 
And then you were offered to go on it again?
 
Yeah. 
 
At what point, because you did the three years, then you were offered again to carry on with the trial and the treatment. But then you decided, so did, was that a joint decision with everybody or?
 
It was Courtney’s decision.
 
Courtney’s.
 
Yeah. It was Courtney’s. Yeah. And then we just told the doctor when we had the appointment last October.
 
Mm. And how did they respond?
 
Absolutely fine. She said, “You’ve done it for three years so yeah, I will write to the hospital.”
 
For another parent, the main reasons for withdrawing were the juggling of hospital appointments with school, work and caring for her family, and her son’s request to stop because of the discomfort he experienced from the tests he had as part of the trial. Sometimes having to explain to a child why the tests are important can be difficult.
 

Sometimes the demands of a clinical trial and the child’s discomfort are reasons for withdrawing....

Sometimes the demands of a clinical trial and the child’s discomfort are reasons for withdrawing....

Age at interview: 39
Sex: Female
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 After the first year we then agreed to continue to have extra bloods taken. And also they do this day assessment where your children have to fast and they measure your blood glucose levels, and this extra scan. And we agreed to all that, knowing that we were having more tests than was absolutely necessary, with an overview of, “Well, actually it’s going to be of benefit medically in years to come, but there’s actually no benefit for us now” because it’s just an extra set of bloods, it’s just an extra test. So we did, we’ve done that and we’ve actually decided to stop now. We, we’ve come to the end of that period and they asked if you want to carry on and we’ve said, “No”; the reason being that our oldest child is eight and he’s at an age where he doesn’t want to have blood taken, and actually now he doesn’t need to have his blood taken. I think it might just be once a year, if that, or something. You know, we’re really down to the minimum, minimum things with the whole, the whole thing. And actually he doesn’t want to. And so that’s fine and I have to respect that. 

 
And it takes time because you have to carve out a day to go into hospital for all these tests to be done. And actually with three children and working it’s slightly more than I kind of feel I’m willing to give. So from a totally selfish point of view I just kind of think, “Well, actually, no, we’ve done that.” And there’s a point now where I want to say we’re not going to do any more. And I think it’s mainly because of the discomfort now with an 8-year-old, where actually you have to explain everything to them. You know, “You’re giving blood because…” you know. And that’s a hard thing to do. And so we’ve decided no, also what was happening in order to juggle with the childcare and working I think my husband was taking a day off work. And we’ve actually decided that, you know, “Okay, we’re going to call it a day and not be of any more help to you. I’m sorry about that.” So that’s the growth hormone trial. 
 
It was just this one nurse who followed it through, who we felt we got to know a bit. And now we’re not part of the trial she’s disappeared. So that slightly feels a little bit odd really because it kind of feels, “Well, you know, bye-bye.” But, yes, no, that was fine. She was persistent and the hospital were persistent as well. And when we saw the consultant at clinic she, they always talked about the trial and even when we were on it they would thank you very much for your help and just say how useful it is and, you know. So I certainly didn’t feel it was something we were kind of brushed to one side with. It felt, you know, that it was important to them and they wanted us to realise how important it was. And they would take time to thank you and do it very well, you know, and do it very appropriately and, and, and very nicely. So we were quite well looked after by the hospital. You know, the cost to us was time and I would say discomfort to my child. And there comes a point where you think, “Actually we don’t need to do this. We, you know, life is hard enough sometimes with small children without kind of adding, you know, adding to it” which was really my thought.
 
 

Alison says it was quite a relief once she had made the decision to withdraw. It felt like the...

Alison says it was quite a relief once she had made the decision to withdraw. It felt like the...

Age at interview: 39
Sex: Female
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 And also it’s a day off school, and actually as you get older that starts to matter more, you know. When you’re little and you’re 4 or 5 it, you know, it’s not such a big deal. But actually as you get, you, as you get bigger it, you know, it, it’s a bigger deal. And I think also part of me thinks, you know, our child is fine. He had this very difficult start to life, not that we don’t want to dwell on it, because it’s part of him and it would be wrong to, to write that off, but actually you do need to move on as well and say actually, you know, “This is where we are as a family. We do growth hormone. For us it works and it works very well. You know, I would recommend it because it’s worked very well for us. We haven’t had any difficulties at all with it. I, you know, that’s where we are really, you know.” So it’s a kind of, it’s psychological, you know, “We’ve done that. We draw a line, draw a line over it and kind of we move on now really.” And it is nice not to have hospital appointments hanging over you. When you look in your diary, “Oh, right, okay” you know to have that kind of freedom is actually, you know, no, it is nice. You do feel quite liberated from, you know, from many clinic appointments.

 
Was it a relief then when you sort of decided to withdraw?
 
Yes, oh, gosh, absolutely, yes, yes, yes, yes, yes. Just felt freed, liberated from, two clinic appointments a year, that’s it, that’s fine. And as far as we know it’s all fairly straightforward. There doesn’t seem to have been any problems with the treatment. So, you know that’s it. Yes, liberated from, yes, from it all, yes. Really nice feeling, yes.
 
A few other parents had briefly considered withdrawing from the trial when their child experienced some side-effects, but decided to continue. For the remaining parents, the thought of withdrawing from the trial had not arisen. However, they would consider it if their child asks to stop or if there were any concerns such as side effects. It is important to report any side effects promptly. The researchers will be able to help manage the side effects, or advise whether your child should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel that they have to keep their child in a trial or that they have failed if they pull out.
 
Even though Lena’s daughter experienced a high temperature after receiving her second dose of swine flu vaccine, they continued with the trial. They kept an eye on their daughter and knew that they could ring the researchers if they were worried about anything.
 

If your child experiences side effects from a treatment as part of a clinical trial it is...

If your child experiences side effects from a treatment as part of a clinical trial it is...

Age at interview: 44
Sex: Female
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 Did you think, “Oh maybe I shouldn’t be doing this?”

 
No, no the only time we thought we shouldn’t have done was when she was poorly after her second dose. But that was only just when she had the high temperature so. No we didn’t feel that we should have backed out at any time really, no.
 
Yes, and even after the first, I mean at any point we could have walked away. If we decided that we didn’t want to go through with the second vaccine or and even the blood tests, when they couldn’t take the first blood test, they didn’t try too hard. I mean she was distressed so they stopped. They could have, they did, you know they weren’t pushy in any way and so once they couldn’t get the first blood test, they said, “Oh she’s distressed, we won’t do it.” And then the next time when she went to take the blood test, she was fine about it. But I think it would have been exactly the same if they still, if they, but they needed the blood really to see whether it had worked. But they weren’t they were very good with a very small baby.
 

 

None of the parents we talked to withdrew their children from a trial because they felt the treatment was not working.
 
We talked to two Research Nurses who emphasise the importance of understanding that both parties, parent and child, need to be happy to take part and that withdrawing from a trial will not affect their child’s treatment and care. A child’s health and happiness always comes first.
 

Jessica, a research nurse, says parents and children need to understand that they can withdraw...

Jessica, a research nurse, says parents and children need to understand that they can withdraw...

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 A lot of people are very willing to spend the time afterwards, some other people have very busy lives and they need to rush on, which is another reason why giving people as much information about what sort of commitment they need to make to the research study is important because then they know what they’re signing up for and also making people aware of the fact that if their lives do change and they want to stop taking part in the study that that’s absolutely okay and they’re not signing up for the whole duration that if they want to come out of the study they may do that and it’s not going to make any difference to the care that their child receives, I think that’s important to a lot of people that they feel that they make a signature and that commits them to the whole thing. So I do make a point of making sure that they understand that there is a get out clause because we don’t know what’s going to happen in the future, sometimes it may be that it’s just too much to be part of this so I think it’s important to stress that as well.

 
I think you just have to explain very carefully to the parents that it’s really important that both parties are happy to do this and that at the moment maybe this isn’t the right study for them but, you know, it doesn’t mean to say that there won’t be approached in the future. And that the reason why we, you know, we don’t ask children to take part when they’re not keen is because it, that’s not, you know, that’s not fair and equal and there are quite strict guidelines that we, you know, we adhere to and that’s right to protect all individuals out there whether they’re children, adults or vulnerable people for that matter.
 
 

Parents can sometimes feel they are letting the doctors down if they want to withdraw their child...

Parents can sometimes feel they are letting the doctors down if they want to withdraw their child...

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 Again it depends on the type of trial because some trials are over within a day, you know, we’ve got a certain study were, the study lasts four hours and then they fill a questionnaire in after a month and that’s the end of it. In others patients are on a clinical trial for four, five, six years. And it’s important really to make good contact with the family so that they can speak to you about any issues that they have. And if they’re concerned and may want to drop out, it’s important that they feel able to sort of discuss that with you which is something that I strive to do. I try and get a good relationship with the family so that if they you know, if they felt that they needed to discuss something further. Sometimes if it’s a doctor whose looked after the child for a long time they may not feel, they may feel they’re letting them down whereas if you’ve got a bit more time as a research nurse to discuss things and have a bit more of a, you can ring me or text me and I can ring you back attitude, you know. I think that works better and obviously you get a good relationship with some of these families who come regularly for a long, long time and it’s important to make sure that, you know, they do realise that they can withdraw if they want to, they can discuss things with you. And sometimes you get into a mire of discussions that are nothing to do with the trial, you know, and help them with other things about the child’s care which is, as a nurse is our role as well.

Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. It is important to realise that, on average, new treatments are as likely to turn out worse as they are to turn out better than existing treatments. This means that, going in a trial, everyone, regardless of which of the treatment groups the computer allocates them to, must have similar chances of a good outcome. If, in spite of the treatment uncertainties that the trial has been designed to address, people would strongly prefer one of the treatments being compared, they should not volunteer for the trial. 

Last reviewed September 2018

Last updated June 2013.
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