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Clinical trials: Parents’ experiences

When the trial ends: feelings, future care and personal feedback

Sometimes a trial involves a one-off or fairly short commitment from parents and children. For these people the end of their involvement was not much of an issue. How people feel at the end of a trial may depend on the kind of relationship there has been between the research team and the patient. All the parents we talked to who had agreed to take part had had a good relationship with the research team and were pleased that their children had taken part.
 

Laura will continue with the skin care advice for her daughter she received during the trial, and...

Laura will continue with the skin care advice for her daughter she received during the trial, and...

Age at interview: 32
Sex: Female
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 I don’t, no, I don’t think they’re going, there’s no follow-up, they won’t keep checking on her. Six months is the end of it. But I will just be interested to know the outcome in the fullness of time, see what the results were. Obviously very keen at the six-months check-up to get the results of the, genetic test, take full advantage of the appointment with the consultant where he, where they will check Beth over really, really thoroughly, and take any advice that the skincare consultant gives. Particularly if she is showing signs of, of eczema, then at least I’ll feel like I’ll have a head start.

 
Are you hoping that the results of the genetic test will be a negative result?
 
I am. And but if they aren’t, then it makes the taking part in the study all the more important in terms of whether oiling will have made a difference.
 
And if they said if it’s a positive result, have they, kind of did they say what would happen then? Or are you just left?
 
Well then it’s GP’s care to deal with it. But of course if she’s showing moderate signs of eczema, then I would probably keep going with the oil and hope that it would, would at least lessen it. We’ll have to see. We’ll cross that bridge when we get there.
 
At the end of a trial on dietary changes in children with epilepsy, Emma asked to keep the same neurologist who had supported her throughout the trial and after it had ended. Emma also had mixed feelings of regret of not starting the diet sooner, and was relieved that a clinical trial had now provided evidence that the diet may help children with epilepsy.
 

Emma’s son continued with the diet after the trial had ended. Having a good relationship with her...

Emma’s son continued with the diet after the trial had ended. Having a good relationship with her...

Age at interview: 42
Sex: Female
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 After the trial was up at twelve months I refused to leave our neurologist. I wasn’t going back to the old neurologist because as you can imagine I wasn’t too happy. And I realised the difference of having a good relationship with your neurologist, somebody who would listen and work with you and not just dictate to you. And Professor is very much one of those where “Okay, let’s work together” and I you build that relationship where you go “Yeah I trust what you say now.” And I actually I’ve got to the stage now where I don’t trust anybody else and I will run everything past her before I even sort of think about it. 

 
Yeah. He was, when we took him off the diets two, just over two years ago, the seizures didn’t come back, but we found that the one’s that he had left did increase in length a little bit. So we put a tiny, tiny bit of med in, to just bring those down a little bit. It wasn’t even classed as a therapeutic dose but it seemed to help Matthew and there were no side effects. 
 
That was more difficult than anything else. I felt like we were taking a step back. But when you sort of weigh it up to where he was to where we are now, it was a little, and it was you know Professor was real careful with it, she knew my feelings on it after we’d been so badly burnt beforehand. So it was always mono-therapy, never any more. A tiny bit to start off really small, only go to the level we need. But two years on and I’ve weaned him off that as well because he only seemed to need that for a while. And then he started to get the side effects of the med again. All of a sudden we started seeing a load more mouth ulcers, the drooling came back. And he was a bit spacey. I’m like, “This isn’t him.” So it was wean off again. And he’s not needed it, so now he’s off it all again.
 
Sometimes with these children with these difficult epilepsy syndromes they may just need something to change, or, and maybe that’s just what he needed for a while, until he got used to coming off the diet. Because his metabolism had changed for so long, that coming off was different for him. But he’s as happy as Larry now.
 
 

She wishes her son had had the diet earlier, but the clinical trial was important to assess...

She wishes her son had had the diet earlier, but the clinical trial was important to assess...

Age at interview: 42
Sex: Female
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 I regret not pushing harder for the diet, but I don’t think it was available, and I think it was being done badly anyway from, from families that I’ve spoken to, that were that had tried the diet beforehand, said, “Oh no, we tried that and it didn’t work.” And I’ve said, “Well what did you actually have to do?” When I’ve looked into it closely I’ve realised the diet was done very badly. And that’s why it couldn’t have worked. There was a plethora of drugs on board as well as the diet. 

 
There was like, so I think if I’d got it done earlier it may not have benefitted Matthew, maybe we wouldn’t have had this, I don’t know. It’s very difficult, it’s very difficult. I still would have liked it earlier to be quite honest, because he responded so well. 
 
I’m pleased to say that the results of the trial, there was 149 children enrolled in the trial altogether. And the results of the trial were published in 2008. And it showed no difference between the two diets; both were just as good as one another. And it did show that the diet, it proved the efficacy of the diet for once and for all. It was class one evidence. And it’s equivalent to any new anti-epileptic drug that’s on the market.
 
Emma has set up a charity ‘Matthew’s Friends’ that supports research into dietary changes for children with epilepsy.
 
Some parents feel a bit abandoned or insecure after all the intensive involvement with the research team.
 

Even though there were follow-up meetings, parents sometimes still felt a bit abandoned at the...

Even though there were follow-up meetings, parents sometimes still felt a bit abandoned at the...

Age at interview: 42
Sex: Female
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 The trial, like I say at the end of the twelve months you were supposed to go back to your own local centre and a local dietician was supposed to liaise with the trial centre, but look after and monitor the child. Dieticians around the country wouldn’t touch it. They just went, “Ketogenic Diet – not a chance. I’m not touching this.”

 
So a lot of us were left in the lurch. From my point of view I was happy, because it meant I stayed where I was and with the team I’d got. But a lot of other families were, were stuck or they, in the end the trial centre had to keep the majority of the patients. But just not on a trial basis. So they didn’t have to come in every three months. So then the follow ups went down to every six months, but you could still phone in and get telephone or e-mail support. 
 
But yes there was still regular follow ups afterwards. And if you had any problems you would phone in. But at the end of the trial you would just finish all the paperwork. It was finished with another EEG, and then they would compare that to the beginning one and that kind of thing.
 
One of the main reasons parents gave for enrolling their child in a trial was to benefit or protect the children’s health. (See ‘Reasons for wanting your child to take part – child’s health’ and ‘Reasons for wanting your child to take part – helping medical science and others’.) When their children were no longer involved in the trials, most parents felt assured that their children would continue to receive the best care and treatment they needed. For parents who took part in trials with a longer term commitment, the trial sometimes became part of their lives. When a trial ends, or children are no longer involved it may lead to a mixture of feelings, such as relief or uncertainty, about what will happen next.
 

Vicky would like to know the outcomes of the trial and whether her daughter’s treatment should...

Vicky would like to know the outcomes of the trial and whether her daughter’s treatment should...

Age at interview: 39
Sex: Female
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 Well, I mean I suppose, I feel that I would quite like to know the outcome of the trial and to see, you know, to see what then they will change as a result, if anything. Because I guess things may stay exactly the same. But it will be useful to know that, you know they had assessed everything and then decided that they would stick delivering information in the same way. But apart from that, no real feelings as it ended, you know.

 
Yes, no, it would be useful, I think. But there was nothing mentioned. And I did, when I came home in fact the other week, last week I did think, “Really I should have asked what happens now.” Because it was all really, “Right, that’s complete and that’s the end” sort of thing, “Thank you very much.” And I should have thought at the time really.
 
 

Kathryn is unsure what will happen with all the information she and her daughter gave to the...

Kathryn is unsure what will happen with all the information she and her daughter gave to the...

Age at interview: 39
Sex: Female
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Because obviously they’re going to have to do something with this information, aren’t they? Otherwise it was pointless doing it in the first place, wasn’t it? So then if it is something to write up for the children to read, then, yes, it would be helpful, wouldn’t it? If that’s what they’re, doing with it. To say, “Well, you could be feeling like this, but don’t worry. So are other children of your age group.” I should hope that’s how they were going to use it. Because if Chloe could have got given something like that, “Don’t worry. You might be scared. You might feel this way or that way. But this is how these other children feel as well.” But I’m not really sure in what way they’re going to use it really.

 
And I haven’t. So now that we’ve had this talk, I feel a bit, well, I’ve left it up in the air really and I don’t know anything more about it. And, and it’s sort of got you thinking a bit really about that I should have found out a bit more at the end really or whether I should have been told a bit more about what’s going to happen with it.
 
Yes, because otherwise you feel like it was a bit pointless otherwise, don’t you? “What did you do it for?” “Why did you sit there?” Yes, it was only a questionnaire form, but there needs to be some end result, doesn’t there? Otherwise it was all a bit, “Why did you do it?” Really, there was no point to it really, unless you know why they’ve done it or what they’ve got out of it really, is there?
 
In contrast, Linda did not feel she wanted to know whether her daughter had the drug or the placebo. “They had said that they would break the code after five years but we’d moved and it’s one of those things where I keep thinking when I lie in bed, ’Oh I must remember to ring them’ and then forget to ring them. But certainly she had no ill effects from the trial. For me it was important that she live her life as her and not as a heart child.” 
 

Whether her daughter received the placebo or the actual drug was of less importance than seeing...

Whether her daughter received the placebo or the actual drug was of less importance than seeing...

Age at interview: 43
Sex: Female
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 No, it was a six month thing where she was injected for six months then it gives cover for I think three or four years they said. And certainly even though I don’t know the results I just anecdotally think that whatever she had, helped or we were just particularly lucky. Because certainly for the first four years of her life you wouldn’t have known that, she was a lot less ill than people had predicted she would be. People had, you know when she’d seen the cardiologist they had said that she would need if she got a cold it would hit her hard etc and none of that happened so. You know at one point I actually started thinking maybe they’d got it wrong and there’s nothing wrong with her [laughter] a bit of wishful thinking I mean because she was doing so well, you know, it was impossible to even contemplate that she would need open heart surgery she was doing that well so.

 
Mainly because I think I have phoned once and they hadn’t broken the code yet. I think the reason I haven’t because she’s done so well that it’s almost now immaterial to me whether she had it. Had she been less well I would have wanted to know. I think because we’ve got to eight, you know, she’s getting distinctions for ballet exams and taking part in cheerleading and, you know, had she been less well I would have more time to focus on her, her heart condition and everything that’s been involved with it. It’s there but it’s there kind of thing, it’s not, it’s part of us on a daily basis, we know that she needs surgery but we are able to, apart from her cardiac appointments, put it to one side it doesn’t interfere that much with us, which sounds strange. Because I mean I do sort of look at her and go “Oh my little girl needs open heart surgery” or she’s with her swimming costume and I think one day there’s going to be a scar running down her. So I do think about it. But we try not to, for me it was important that she live her life as her and not as a heart child. She’s a child who has a heart condition but she’s not a heart child, you know. I want her to live, sustain life but I also want her to have a life while she’s alive so I do let, I mean her cardiologist said that there are children who are never even allowed to learn to ride a bike. Because with heart children if they fall then they can get if they get an infection, if they get a deep cut they’re meant to have prophylactic antibiotics so they don’t develop endocarditis. So the parents won’t let them ride a bike in case they fall down and cut themselves. And for me I don’t want her to die but I want her, if she lived until she was 20 having had a full, loving, wonderful, exciting filled life with rides on Lego Land etc. then that would be more important for me than that she was kept locked away never able to do anything and live to a 100, you know, so, I want her to have a good quality life. And because she has had, she’s had such a full life, her test results have almost become, you know, not an irrelevance but I almost don’t need the test results because I know that whatever they gave her a) it didn’t harm her and b) almost did her some good so. It would be more of an interesting point to see whether I was right that she had had the real one because she did so well for the first few years of her life, you know. Which is the bit where they said would be the danger part so.
 
For parents who had taken part in a vaccine trial, the main thing was their child receiving early protection against harmful viruses, such as swine flu and meningitis.
 

At the end of the trial, knowing her daughter had immunity to swine flu was important to Lena.

At the end of the trial, knowing her daughter had immunity to swine flu was important to Lena.

Age at interview: 44
Sex: Female
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 No, no, I think, I mean because the trial, like it was quite a while afterwards the results took to come out. But I remember phoning up and saying was she covered by the swine flu because we hadn’t heard. They’d given us a date, I can’t remember what the date was, they’d given us a date and said that you should hear by this date. And I’d contacted them and said, “We haven’t heard.” And they said oh it’s because, I think the postal strike, there was a postal strike on or, so they said “We will contact you.” And they did contact us. And then they phoned again to check that everything was okay. So it was; they were very informative. Yeah.

 
And in terms of the study overall, have you had any results to say which drug you know, if there was any mention of this?
 
No I didn’t, I didn’t really think I wanted to find out whether she had the drug that, because, because it had worked for h and that she had an immunisation against it, then I didn’t really feel that I needed to know whether it was the drug that they’d used or not really. I, I’m sure I could have found out because, but I decided not to you know once...
 
You didn’t want to know any more?
 
No, yeah, yeah, definitely.
 
It’s interesting that sort of idea, not wanting to know. [Yeah.] If, if things hadn’t have gone so well, you might...?
 
Yes, yeah we were happy with the outcome. She was covered. She didn’t get swine flu. So we were happy that everything had gone the way that we wanted it to really. So we thought no, there’s no point really finding out whether it was the drug they didn’t use or not. Because both drugs had been trialled, it was just really as to which one they were going to use.
 
And if hadn’t have gone so well, would you have wanted to know?
 
Possibly would yeah. Try and find out more information. Yeah. Yeah. I think that’s with most things isn’t it, if things go well then you don’t need to look further. But if you’re not happy with something that’s when you dig deeper isn’t it really? I think.
 
Most parents commented on how important it was to know about the results of the trial and to find out what the effects of the treatment were. This is discussed in ‘When the trial ends: feedback of trial results’. Parents felt it was important that their children know that they had made a real contribution that would improve care for others.
 

When the trial ends her Lucinda’s son might feel relieved not to be taking so many tablets every...

When the trial ends her Lucinda’s son might feel relieved not to be taking so many tablets every...

Age at interview: 37
Sex: Female
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 I think Toby will be relieved not to have to take eight tablets a day. But then maybe he’ll just go on to one tablet a day or what, whatever the dosage is for the medication. I don’t think it’ll make much difference to us, because it’s not a major thing to take medication in the morning and in the evening. I know it is for, for children. But I think because he’s got used to it and he knows that it could possibly lead to something that’s going to help him, I just don’t think it makes that much difference. Sort of two seconds out of your life, isn’t it? So, no, I don’t think it’s going to make much difference at all.

 
Yes, I think it is. I think there’s a, there doesn’t seem much point in doing a trial and then not knowing the outcome of it. You know, ta, doing something for fourteen weeks and then thinking, “Oh, right, well, that part of your life’s gone.” I think it’s nice to carry it on and see what, what comes of it.
 
In screening trials, waiting for results can be a stressful time.
 

The trial was only three days, but waiting for results was quite stressful for Nikki and Chris.

The trial was only three days, but waiting for results was quite stressful for Nikki and Chris.

Age at interview: 38
Sex: Male
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 It was, for three days she had to chew this cotton wool as soon as she woke up. And on the third day, that afternoon we went to the hospital and they did the, the test. And it was the following morning that we got the phone call to say, “Come straight back and, and we’ve got medicine here for her.”

 
So that was that quick?
 
It was very quick, yes, yes. And it was only about, it was about ten days from that hospital visit where, you know, this had all come up to the start of the, the trial, doing the trial, which again was good for us because you just want to know. Once, once that question is, is raised, you want a test done, you want everything done quickly and the results quickly. [Speed.] Yes, because you’re worrying. You know, you, you’re worrying anyway, but as soon as they say, “There is a possibility” you just want to know.
 
So those three days, was it very demanding of your time? 
 
No, not really. [No.] A couple of meetings, which could have been quicker if we’d been in a rush, but we weren’t. And the test, the trial itself took sort of ten minutes each morning for three days.
 
Yes, and then, then in the hospital, we were in the hospital for, it’s about an hour and a bit, the test actually took; because they have to, they take the blood first of all and then they put the, the drug in. And then it’s over the, it’s three different times that they then, they leave the line in and then take blood at three different times, don’t they? I think it’s every 20 minutes, three lots. And then they take it all out and you go.
 
[Husband] Even after the, I can’t think, I didn’t know what the drug was that they injected, I can’t remember, even after they put that in she didn’t reach the base level they would have expected before the reactive drug.
 
She had the lowest test results that they’d, they’d ever seen. So it, so it was a good job that we, we did it.
 
I mean how did you feel going through the whole, I mean it’s just three days, it’s a short time, but it must have been like [forever]?
 
Well, to be honest, because everybody kept saying, “It’s to put your mind at rest, mum” I sort of thought, “Maybe I am being a bit neurotic. But I just want to know.” So, so we weren’t, although we wanted the test done and, and everything, everyone that we spoke to was saying, “Oh, it won’t be anything. It won’t come out as, as there being, there being any sort of problem. It will be fine. It’s just to put your mind at rest.” And that’s, that’s really what we wanted, wasn’t it? And, and I think again it came about because school, the school that she goes to are very, very strict on attendance. And she had terrible attendance and so we were getting these, these letters saying, “You must take urgent action.” And I was going, “Well, what do I do? She’s ill.” So really we wanted to know as well where to go next, because she was ill all the time. You know, whether, if the, we were thinking, “If the test results come back and she’s fine, then do we need to give her vitamins? Do we need to do?” You know, that’s all we were thinking is, because everybody was saying, you know, you did sort of feel a bit like you were being neurotic. But you know, don’t you? You know your child and you know when something’s not right. As I say, especially having other kids we knew that, you know, if they got the chest infection that she h
Full trial results are often not available for some time but personal feedback was important to parents. Alison’s son used his trial records to do a presentation at school.
 

Alison kept the personal feedback from the tests her son had taken during a growth hormone trial...

Alison kept the personal feedback from the tests her son had taken during a growth hormone trial...

Age at interview: 39
Sex: Female
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I think that’s, that’s quite a nice thing to think about, that it is actually your child, this is their results. 

Yes, it is, yes, no, definitely. Well, actually what’s interesting was when we had all the scans for him at the hospital, they print out and they give you a copy that they give to the doctors, and actually he’s got them all, I think tucked away in his red little book somewhere, and found it really interesting, I mean to, percentage of body fat and all the rest of it. And, you know, and I feel, well, it’s important though, you know, they are his [results] I was quite kind of pleased that he took them into school. I don’t know what anyone made of them, but he took them into school. And he has asked questions about his blood, you know, “Where does it go? Where’s the lab in the hospital?” You know all really relevant questions that need to be answered. Because it’s quite a bewildering thing really, “Here’s mum and dad. We’re going to sit you in a room and, you know, let some, you know.” It is, it's a difficult thing for a child. And of course you manage it and the hospital manage it and we make it as nice, but you know those are real questions. Now fortunately for us it, we haven’t, you know, it’s not been too much of a drama. But, you know, it could be, it could be very, very easily, you know. And the other two children have had to watch that as well quite often if childcare has been a bit cobbled together and not there, you know. The, yes, middle child has watched the eldest one having blood taken. You know, and okay that’s fine, you know, but question, you know, you do have to have answers as to, you know, why we do this. And actually we’re doing it for the good of others we think really. You know, it’s a hard thing for a child to understand, you know, it’s very hard. It’s a hard thing for lots of adults to understand but, you know, it’s a hard, it’s a hard thing for a child to, to grasp.

 
Yes, I would actually, to see if it makes interesting reading. And I think it’s important actually to give to my child when he’s old enough to want to have that information, to say, “Actually you were part of this. You know, actually it’s your information. Although it’s addressed to me, it’s you, and that’s part of your history and identity. You can then decide to do what you like with it.” But, you know, so, yes, it would be.
 
For many children, long term follow-up will be a part of on-going treatment, but this may not be as intensive, or involve such closely monitoring. Of course this can apply equally to the ending of any long term period of care, whether it is within a trial or not.
 

Stopping involvement in the trial meant fewer hospital appointments and fewer tests on her son,...

Stopping involvement in the trial meant fewer hospital appointments and fewer tests on her son,...

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, 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.

 

Helena, a senior research nurse explains that ending a trial doesn’t mean an end to their...

Helena, a senior research nurse explains that ending a trial doesn’t mean an end to their...

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Yes and I think even when studies are finished it’s important that people do know that they can still contact you. Because it’s, and either that the studies finished and they’ve come to the natural end of the study, if there’s something happens and they think well is that related to the study or not, we always sort of say if there’s any problems give us a ring back and we can either help you with it or put you in the right, point you in the right direction.
 
So that means that even when the studies ended they can still actually speak to you?
 
Yes, yes. Because I think what tends to happen is the studies, they get, not a better treatment but they get a bit more contact maybe or have a more of an open door than when they don’t. And I think sometimes at the end of the study maybe families think “Oh gosh what do I do now, who do I contact now about something”. You know especially if they have come to our hospital from a different hospital and they’ve been referred just for the study, in a way they’ve then lost contact with their previous hospital even though we do make sure that we can, you know, let referring doctors know what’s going on. We want to make sure that they don’t feel like they’ve just been left and thanks you’ve done our study now thank you bye, that’s the end of it.
 

Last reviewed September 2018.
Last updated June 2013.


 

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