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Clinical trials: Parents’ experiences

What is involved in a trial: appointments and monitoring

When your child takes part in a clinical trial it usually involves some visits to a hospital clinic, GP surgery or research unit. Sometimes an overnight or longer inpatient stay may be needed. This depends on the type of trial and the intervention being tested. For some parents the trial took place when their child was in hospital.
 

Catherine’s son was on the neonatal ward and the trial required stool samples. The staff helped,...

Catherine’s son was on the neonatal ward and the trial required stool samples. The staff helped,...

Age at interview: 27
Sex: Female
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 The first time Mikey was on the Neonatal Unit for three and a half weeks after he was born because he was premature. I guess it was one of the researchers just came when we were by his incubator and they were doing a study into, I can’t remember the exact bits about it I’ve probably got the paperwork somewhere, they were doing a study into looking at some gut deformities and bowl deformities in poorly babies.

 
And they wanted to use Mikey’s stool samples as a comparison because he was healthy, he was just very small, he was healthy in bowl and gut we believed. So it was a fairly non intrusive study. We had to collect all his stool samples for five days and then there was a break and then we had to do it again for another five days, which actually wasn’t too involved for us because the nurses did a lot of that anyways, [laughs] so it was really quite un-intrusive for me and my husband. And, yeah they, I knew it was all anonymous, we signed consent, all of the, all of the tubes when we did do it were all, he had a number, he was not identifiable and I just thought if it could help them with whatever they were doing then that was fine because it didn’t have any implications on him really.
 
 

Taking part in the trial was made easy for Alison when she was on the neonatal ward and for the...

Taking part in the trial was made easy for Alison when she was on the neonatal ward and for the...

Age at interview: 39
Sex: Female
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 So that was our second trial, which, which was fine. And I was very happy to take part in them. I mean obviously in, in terms of time it, it didn’t really impinge on us at all because we were in hospital anyway in a neonatal unit. So our child being given antibiotics, he would have been given antibiotics anyway. You know, it didn’t particularly affect things. The only thing it did affect was I suppose the two-year appointment, but that was on the back of a hospital appointment so it was made as easy for everybody. So it had a very low impact really upon us and the family. More interesting to read and, you know, from a healthcare perspective, and, and, and to see, you know, those kind of developments and how people are thinking and how that affects, you know, medicine really. So that was that trial.

Some trials may involve treatments that can be taken at home, such as tablets or self-administered injections. In these cases, the research team or health professionals involved in the trial may come to your home to support you and your child through the trial.
 

Charmaine’s daughter took part in a growth hormone trial for five years. It involved an overnight...

Charmaine’s daughter took part in a growth hormone trial for five years. It involved an overnight...

Age at interview: 36
Sex: Female
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 And then we was in overnight for these tests and that. And she had to have blood tests. An x-ray of her bone age and a scan of her whole body. We stayed in overnight and we came back the next day. And then she just started on them and she was having them every, every day. I tend to do it like after dinner, after tea at night so we knew and she was on them for five years.

 
But we had to keep going up to the hospital every six months Courtney had to be weighed and height. And then we and then she had to have blood tests as well. And then she, she’s been on them and like she came off them last year, in 2009, because she was twelve and she started High School and she didn’t want them anymore. And we just let the doctor know at the hospital. 
 
 

It was helpful to have the nurses visit the home to demonstrate the injections, although her...

It was helpful to have the nurses visit the home to demonstrate the injections, although her...

Age at interview: 36
Sex: Female
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 And they, the lady came round to the house we were living in. And there was two of them, that one was the nurse who showed us how the injections worked and also the other lady was she’s been with us ever since like we started them. I think she was the nurse as well from the hospital. And then when it was time, when they were showing us how to do the injections Courtney didn’t like it and she didn’t want it done. So I had to like pretend and demonstrate on my stomach but it didn’t hurt, because it didn’t hurt. And then obviously she tried it and she was absolutely okay with it.

Sometimes the demands of a trial may interfere with other activities and sometimes other members of the family may become involved. (See also ‘What is involved in a trial' time commitment, costs and payment’.)
 

Charmaine took the injection kit on outings and family holidays, but sometimes having daily...

Charmaine took the injection kit on outings and family holidays, but sometimes having daily...

Age at interview: 36
Sex: Female
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 Yes and well it isn’t really. It’s a big, like for me and my husband, but it’s when, its family as well. Like if Courtney went away with the family, the injections had to come, you know? And I had to show the family what to do and how to do it. You know. And then I think the year that she left primary school they have [name of place], it’s an activity, a couple of days of activity and that. And I remember like saying, “Oh are you going on, are you going on this activity?” And like, “We’ll pay for you.” And she said, “No.” I said, “Well why?” She said, “Because I’m on growth hormone injections.” And that stopped her from going because she didn’t want; the only place that she’d ever have her injections was in her bottom. She wouldn’t have it in her tummy or, no it was always in her, in her bottom.

 
And did she say why that was? It was just
 
Because obviously with the teacher you know, doing the needle injections.
 
Involving the family in giving Lisa’s son his injections was a great help, especially for family outings. It is encouraging that her son has now learned to do the hormone injections himself as part of a daily routine.
 

All the family have been trained to give our son his injections and he has now learned to do them...

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All the family have been trained to give our son his injections and he has now learned to do them...

Age at interview: 37
Sex: Female
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 Well being about on his growth hormones and it is, but he’s happy being on them and it was recently that he was the one, he said, “I want to do my own injection now. I don’t want people to be doing my injection any more. So, I want to do it.” So he’s just been trained up to do his own injection because he wanted to do it, and then he says, “If I want to go to, out and about, you don’t have to,” because he’s has to have it roughly at seven o’clock every evening, so that could be a bit of a tie. That wherever Callum was he had to have an injection at seven, but most places where he goes, it’s like my parents or family, they’ve all been trained up to give Callum his injection. But now Callum can do it himself it doesn’t really matter where he is, or whatever, as long as he’s got his injection to give it himself at seven. It’s just because Callum does go to bed fairly, fairly early. It has to be just before they go to bed you see. And they like it the same time every night, so it’s just before they go to bed at night, so yeah. We do it at seven because when he first went on it they said make it into like a routine where he has his injection, brushes his teeth and goes to bed. So if you put it in the routine then you don’t forget it.

Whatever the intervention, staff running the trial will probably want to monitor your child’s progress and this may mean attending appointments for tests and discussion, as well as for treatment. (See also ‘Side effects’). Dr William van’t Hoff explains what parents might expect when their children take part in a clinical trial.
 

In order to check how well the medicine, or treatment, is working, taking part in a clinical...

In order to check how well the medicine, or treatment, is working, taking part in a clinical...

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 Clinical research is different to ordinary care in the way that it is governed and the standards of research practice, and they generally are much stricter. Research will often involve some extra things to do, perhaps an extra medicine to take or a different medicine to take, and perhaps extra visits to a hospital or a clinic, or an extra blood sample or things like that. And part of this, these extra visits and extra tests are there to check how well the medicine might be working, but also to check on the safety of the patient, in this case a child. It’s important when a research plan or protocol is explained to a family that they have a clear understanding of what the plan is and can see which parts of the study, of the trial are different to the ordinary care that they would receive. It’s very important that families and children know that they are, have a complete opportunity to take part, yes or no. It’s a voluntary action. And they should remember that that voluntary action can be stopped at any point. They can withdraw from the study if they’re uncomfortable and don’t want to do it or their child expresses a wish not to go further. It is a voluntary act, for which researchers are extremely grateful that they are taking part in studies to help for the health and treatment of, of their child or other children as well.

 
And so parents might expect to attend more appointments or they may have to, the child may have to have more tests done than perhaps would be in their normal treatment plan?
 
Often research studies will involve extra visits to the hospital or extra tests. And it’s important when considering whether to take part that the families understand clearly what their obligations in that study would be. And the researcher has a duty to explain what parts of the study are extra to the normal care they have and which parts would be part of their routine clinical care.
 
John’s daughter took part in a trial to monitor blood glucose levels during intensive care. After discharge she will be monitored for a year to check on her progress. John says “The information supplied was excellent”.
 

Continued monitoring of your child’s health is an important part of the trial. John knew what to...

Continued monitoring of your child’s health is an important part of the trial. John knew what to...

Age at interview: 35
Sex: Male
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 And the plan now is to do a follow up progress, really to keep a diary for the next twelve months on, [um. um] whether she has any medication, what medication she has is for, if she’s back in hospital for any reason. And they’ll send us a questionnaire in twelve months in terms of how she’s been in herself, how she’s been medically. What intervention she’s needed if any, what our thoughts are etcetera. It seems to be quite detailed, well thought out, well prepared, well put forward.

 
Yeah, I mean as long as she was intubated then she was on Chip Trial. So about a week and a half later she was exubated and once she was exubated they take a snap shot of all her readings, blood gas, blood sugar levels, CRP levels, blood oxygen levels etcetera etcetera. And the idea is to compare that to when she was first on the trial across the stages to the end. And that’s it, job done. Obviously from a personal point of view they wanted to follow up with her to make sure she was okay, you know the doctors and nurses who had been dealing with her during the trial kept popping their head through the door to see how she was doing so you know very impressed overall really.
 
And the follow up, that’s sort of going to be you’ll get a questionnaire or something?
 
Yeah, yeah. They’ve given us a copy of everything that we’ll receive already. So, again I’ll show you that, it’s just basically you know ‘Thanks for taking part, this is the next stage, this is what we are looking at doing, can we ask you to keep a diary, this is the questionnaire that we’ll be sending to you to so you at least know what to expect, if you would be kind enough to send it back to us we’ll send it to you in a year’s time that would be great’. 
 
 

Ann takes her daughter to the hospital every two weeks for tests, but this may change to once a...

Ann takes her daughter to the hospital every two weeks for tests, but this may change to once a...

Age at interview: 43
Sex: Female
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So tell me about what actually happens, what’s involved in the trial.
 
She just goes, every couple of weeks she has her bloods taken, her height, weight. They check, as I say, they check her bloods. And just basically going in, having a little formal chat with the nurse. And she loves going. She loves the popularity of it. Because she, it’s so uncommon, she gets the, “This is, this is Emily. This is my little Graves’ child.” And she loves it. She loves the attention.
 
And is it regular? You know, I mean is it, do you have to go every..?
 
Well, we go every two weeks. Well, we’ve been going every two weeks. Hopefully this month we might have a break and go monthly. We haven’t had a phone call yet. So whether we’ll get one. Fingers crossed that we don’t.
 
So is that part of the trial? You know, how does it work then, the trial, what actually happens?
 
They just check her bloods; check her height and her weight to see how she’s gaining, just basically to see how she’s doing, how she’s coping.
 
Do they take any samples, blood samples or anything?
 
Oh, yes, they take her bloods every, well; they’ve been taking bloods every fortnight. Just basically checking her well-being and how she is.
 
So what are the, you say it’s a drugs trial?
 
Yes.
 
So what is it about the drugs? What’s being randomised and what’s actually Emily on?
 
Well, she’s on the carbimazole for the thyroid. And they, she, they’re doing block and release with Emily, which, they block the thyroid and then slowly release it to find a happy medium. So when the thyroxine goes up, the medication will go up. When the thyroxine comes down, the medication will go down.
 
And how does that work? Do you have to, who monitors that? How do you know?
 
It’s a blood test monitor. When she goes for a blood test they check this. And like they said that the tablets that she’s on, they can cause side effects. If she gets a sore throat at any time, accompanied by any blisters, she has to go and get her white blood count sorted and checked, because the carbimazole attacks the white blood cells cause problems with the medication. It can end up producing a sore throat.

As well as attending appointments, you may be asked to record what is happening in other ways, for example, by keeping a diary, filling in a chart, or completing questionnaires. Jo’s son had to take tablets daily for six months. Although the care and support of the nurses and doctors was “fantastic”, Jo found it “a little bit daunting, to realise that eventually he’d be on eight tablets a day for quite a few months”.
 

Jo found reminding her son to take his medication morning and night every day for six months...

Jo found reminding her son to take his medication morning and night every day for six months...

Age at interview: 28
Sex: Female
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 The, like, the other thing, and it, it’s daft, but it’s so hard to remember to do something twice a day every day. It is really difficult. I mean there’s, there’s, obviously there’s me and there’s Dan and there’s his dad, and some days we, you just, you just completely forget and you, even though you’ve been doing it for weeks and weeks and weeks. I think you; also you only fill in the diary at the end. So you only have four weeks to fill in the diary at the end. And even filling in the diary we were, some days I’d be like, “Oh, I’ll have to go back three days and make sure I’ve ticked my ticks.” And there’s not, honestly, even just a little beeper that went off at 8 o’clock in the morning and 8 o’clock at night, something that, that… You know, maybe if I’d have set my phone to beep at me or something like that would have been better than just, we did have a checklist as well that we put on the fridge, but because it was on the fridge every day it just got ignored as well. And that, that’s, honestly, that was the worst thing about it for us. And I don’t mean worst thing as in it was time consuming, I just mean that it was, trying to remember every single day, it was a lot more difficult than we anticipated it would be.

 
We are a little bit sceptical now about what the future is going to hold for him. We didn’t really want to put him on tablets daily. That wasn’t the aim we were after. But it, it did seem to, to work for the majority of the time. But it’s a lot to ask a child, to take that kind of medication every day. And remembering to take it every day is not easy. Regardless of the, the books that you get given and the check sheets, it’s still really difficult to, to remember. He reminded me more than I reminded him. They, we could do with like a beeper, you could do with a beeper of some kind, you know, to go off in the morning and at night when you’re supposed to take them. Because a lot of times it was like, “Oh.” [Forgot?] “Damn, yes, forgot.” But apart from that, 90 per cent of the time I think we remembered. But it was, I think, harder work than we expected, if I’m honest.
 
 

Her son coped really well with taking his medication every day.

Her son coped really well with taking his medication every day.

Age at interview: 28
Sex: Female
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 And did Dan mind at all, doing that every day?

 
Dan did, Dan, Dan, come the end of it, Dan was the one that was like, “Shall I get my tablets before I brush my teeth?” And we were like, “Yes, do that.” He, he was very good. If, if we forgot, he was generally the one that reminded us. But, as I say, the thing was him remembering to go up and down. That, that’s obviously my responsibility. You know, “It’s time to only take two now, Dan” or, “It’s time to only take one now.” So I was hands up, the culprit for that one. But Dan, Dan felt, I think he felt quite special. I don’t know whether, that’s, I think that’s how I’d describe it. I think he felt very much, whenever we go to the hospital, he, he gets excited to go. [Does he?] Yes. Well, we had, we’ve had so long of having appointments for his eyes where he’s been sat in a waiting room and we’ve been there for hours on end waiting for a doctor to tell us, you know, to go back and come back again. Whereas it seemed like Dan was the only one they were there for, and he was, he was made to feel extremely special. And they gave him little teddy bears, which he called [Doctor name], his little teddy bear. He named him after his doctor. And he’d take him whenever we’d go back. So, yes, he, they, he was, he felt quite special with it all, I think. And he got quite good at remembering to take them.
 
I was going to say how did he feel about going through the whole thing? But he was made to feel special?
 
Yes, he was made, yes, he was fine with it. He was absolutely fine with it.
 
Jo’s son is still in the trial, and is currently in an eight-week gap without the trial tablets to see how many migraines he has. After this period Jo will take her son back to the hospital for an assessment and further treatment, as required.
 

Lucinda isn’t required to keep a diary, but keeps a note of the dates her son has a migraine and...

Lucinda isn’t required to keep a diary, but keeps a note of the dates her son has a migraine and...

Age at interview: 37
Sex: Female
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 Just basically start the medication. Before he started the medication he had a four-week period where he kept a diary, logging the migraines and any auras. Since the medication started we haven’t had a diary to keep, but I’ve been keeping one for myself anyway, just so I know what dates he’s had migraine. Basically just to take his medication, which he’s very good at doing. He’s never missed any. And just monitor. If at any time I feel that his symptoms or he’s getting bad side effects, I can stop the trial immediately. And that was made very clear to me from the outset. You don’t have to take part. Not just myself. If Toby didn’t feel comfortable with it, he could stop taking medication. He’s had a few nosebleeds on the trial. And he’s had three migraines. But I think we’ve been doing it since October, October the 31st, so it’s actually, he’s done quite well considering he was having them two, three times a week. And I’m not saying that’s anything to do, it might not be. But that’s why he’s happy himself to stay on the trial. And I’m happy for, to support that.

 
If it had, if he’d have got worse or there’d been more, would you…?
 
I’d have stopped then probably, yes. And I think Toby feels the same. If, if it had had anything that would have made him feel more that he couldn’t carry on with day-to-day living activities like playing out or going to the scouts, different things, he would have stopped. Because he’s quite strong willed and he knows his own mind. But, no, he’s been, he’s been fine. And he’s happy to see it till the end of the trial. So I’ll support him in that.
 
 

Emma didn’t mind the hospital appointments and the monitoring; she knew her son was being closely...

Emma didn’t mind the hospital appointments and the monitoring; she knew her son was being closely...

Age at interview: 42
Sex: Female
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 But as far as the clinical trials side of it was concerned there was a lot of paper work involved, obviously consent forms had to be signed, I was more than happy with this, the team explained everything that was going on, they explained that I would have to go up to the hospital and visit and take Matthew in for bloods and EEG’s and all the tests that would be that go along with it. And I was more than happy with this because again I was just happy we’d be so closely monitored. It was it was good in one respect because it really made you focus on your child. For me, it sort of focused on the treatment for Matthew, how he was and the difference it made because I had to fill in seizure diaries and even though I had been doing it before I was now watching absolutely everything and it made me very aware. I felt actually more in control than I had done because it was very it was very rigid, I had to complete this, I had to do that. 

 
So the commitment and the control side of it I liked because it was very organised, it was very you know, strict in how you did it. So it was a very positive experience for me and because it was a dietary therapy as well. So I was very pleased with the way it was done. I was very pleased obviously with the results that it had on Matthew, completely changed all our lives. So I had nothing really but the positives that I gained from our experience within the trial.
 
Children who took part in vaccine trials, had blood samples and injections as well as health monitoring at home. Parents were asked to record changes in their children’s temperature, redness or soreness around the injection site, and any other changes observed in their children’s health. If parents were concerned about anything they were asked to seek medical advice immediately. A common dislike among children was having blood samples taken. Both Lena’s and Rachel’s children took part in swine flu vaccine trials.
 

The first appointment was long and quite hectic and Lena’s daughter didn’t like having blood...

The first appointment was long and quite hectic and Lena’s daughter didn’t like having blood...

Age at interview: 44
Sex: Female
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 She was the first appointment, quite a long one. Because you had to have a blood test taken, which she wouldn’t let them do, but it was, she could still go ahead. But they wanted to take a blood test, a sample to see whether she actually had an immunity against the swine flu already. But they couldn’t take that one, but they also then had to do to check her over that she was fit and well for the study. And then she had to have the first swine flu jab. And then we had to wait afterwards so a very long appointment. And as I said before that she, we, well we foster, and we had a newborn foster baby with us at the time, but, so it was quite hectic and it was very, very busy there, with lots of people. But the staff were really, really nice and the nurses were dressed in you know, bright coloured uniforms, and there was a television playing. But Matilda was a bit too young to actually appreciate, but I watched it. Well as much as I could with two babies, but, yeah, no it was very good. It was, they did a very good job, and they were very informative; lots of information, lots of help numbers. 

 
They gave us a pack which we had to bring home with a ruler, a thermometer, and a check list. We had to measure any redness. We had to take the temperature at certain times of the day over the next few days to see whether there was if they had a temperature, she had a temperature and to any difference in her behaviour at all. And the first; after the first jab she had, no change at all. There was no, she wasn’t affected at all in any way.
 
If I remember there was about a month interval between each, so it was October November and December that she actually had the three appointments. The second appointment, I can’t remember now what the second appointment was for. It wasn’t the jab. It was just a follow up I think. And the third time we went, no the second appointment, sorry, the second appointment she had her second jab. And there was no blood test on that one, just a jab. And she was when, she was fine when she had the jab but she was, when she, afterwards she was quite poorly with the jab. It really had, the vaccine had obviously, the second dose had really, and we did think, “What have we done? What have we done?”
 
But she had such a high temperature. It really was very, very high. But then we thought if she hadn’t have had the vaccine and she’d got the swine flu, what would her temperature have been like? How ill would she have been if she hadn’t had it done, so? And it only lasted 24 hours. And it was all recorded down and written down and we handed it to the, you know the staff. But we weren’t concerned enough to phone up, because we knew what was causing it, it wasn’t like she suddenly had a temperature and we had no idea. We knew exactly what it was, and that it was the vaccine that had caused the, the temperature. So it was a bit concerning but at least we knew what it was really.
 
And the third appointment we had to go, we had to put this little patch on her hand, and some cold cream. I can’t remember what that was for now. Oh that was because they were going to take a blood sample that was it. And they did manage to take a blood sample from her after the third one.
 
And yeah she was fine. She was fine with that. And that appointment was like really quick, in and out, no trouble. So, yeah, it was. And she’s been fine ever since. And of course they sent, sent us the notification that she was, she was, it had taken and she had immunity against swine flu. And then of course nothing really ever came of it did it really?
 
 

Having blood samples was the worst bit for Rachel’s children.

Having blood samples was the worst bit for Rachel’s children.

Age at interview: 35
Sex: Female
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 And then they had a blood test, well, blood taken, which was the worst part of the whole thing. So they all had, well, I don’t think they managed to get blood from all of them actually. Certainly the second time we didn’t. I really can’t remember. I don’t think we got blood from one or, no, from two of them we didn’t. The eldest two didn’t give blood. The youngest one did, under duress. And then the randomisation happened, and that was just like a blinded, an envelope really. So they just picked envelopes according to allocation numbers, and then the vaccine was given. And then we were shown how to do the diary cards. So for the next two weeks we were taking daily temperatures and checking the site of the injection to see if there was any redness or swelling and just any other sickness, diarrhea, any other kind of illness really. And then two weeks, I think it was, might have been a week actually, but anyway a period of time later we then went back and they just had the second dose of the vaccine. So that was a lot quicker obviously. And then again we went away for a week, two weeks, whatever it was, and daily temperature monitoring again and looking at the site of the injection. And then at the final visit, they went back and they had blood taken again, just to sort of look at the antibody response. And that was it then. Yes, yes, that was the end.

 
And, because that’s what other parents have said, that the, the giving blood was the, the bit that the children didn’t like.
 
Yes, no, they didn’t at all. I mean they didn’t like the injections, but they were so fast that they don’t really know. Yes, but actually giving blood was, was hard for them. It was hard for all of them. My eldest, he, because he was, he was very pleased about taking part in the trial. For him it was kind of a big thing because we’d said to him, “You’re help, you’re helping other people. And you’re going to be one of the first people in the country to get the swine flu vaccine as a child.” And he, he really was proud of that fact. And he really wanted to give blood the second time, you know, final time. Because we were saying, you know, “That’s part, that will help.” And he was very worried about whether he’d get his sticker if he didn’t and all of these kinds of things. And he got himself in a complete state about it and wouldn’t do it, couldn’t do it. Just, for about half an hour they were trying. And he just got so upset about it and sort of walked out and couldn’t do it anymore. And he then had a chat to Daddy and in the end he kind of came in all brave and did it. And he was incredibly proud of himself for doing it. So he did manage it, but I don’t think, I think it was the other two then that we never got blood from that time.
 
And how did you feel about that, when they, you were seeing that? Did that bother you at all? Did you have reservations at any of, any of that?
 
It’s kind of mixed really. Because initially, actually I do remember feeling, the first time we did it, so when they were originally taking the first blood sample, I got the impression that if they didn’t give blood they wouldn’t be able to take part in the trial. And I did want them to. So actually I was a bit upset that they didn’t get blood out of one of them, or two. I can’t, I really can’t remember what it was now. But I initially thought that meant they couldn’t take part. So I was worried at that point. But when they then said, “No, no, it’s fine. They can still do it, because we use other measures as well” I thought, “Oh, that’s okay then.” So the second time round, when they were doing it the final time, I was concerned for Evan, my eldest, because I didn’t want him to be too hung up about it and I didn’t want him to become phobic about it. So I was glad he did it. But the others I wasn’t really too bothered about really. I thought it would just; I didn’t want to, I didn’t feel it was worth upsetting them about it really. It wasn’t that important.
 

Although it was fun at first, Rachel’s children tired of having their temperature taken every day.

Although it was fun at first, Rachel’s children tired of having their temperature taken every day.

Age at interview: 35
Sex: Female
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 And when you say they enjoyed it, it, was it the, the bits they had to do at home or just the whole?

 
It was the whole process. It was the idea that there was something special about what they were doing, that they were helping people and that they were the first people. Evan was very, particularly very pleased about being the first person, in the country as far as he was concerned, to have the swine flu vaccine. So he was pleased with that. And the younger one, he was almost five at the time, he, the certificates worked fantastically well for him. He was very, very pleased with his certificate. Very worried he wouldn’t get it, and, and that was a big thing. And they, they liked the little plastic envelopes that all their things came in as well. So the daily monitoring that we did, they all had a plastic envelope with a ruler and a thermometer, and that was, for them that was great. So having something that belonged to them for the period of that trial and bringing it back in, they, they definitely liked that.
 
So that was good then? [Yes.] And was it much, was it, when you say it took ten minutes, was it very demanding of the time in what you had to do at home?
 
It wasn’t very demanding, but it was demanding, to be honest. It, it was a bit of a hassle, but it wasn’t a terrible hassle. It was just something to remember. And by the end of it they were all getting really fed up of having a temperature taken. And the youngest, Barnaby, he was, he was 2½ at the time. So it was a real struggle to get him to sit still. He wouldn’t sit still. So we were literally having to hold on to him to try and get his temperature. I think it was just because it took so long. But it was a bit annoying.
 
In addition to a child’s physical health and wellbeing, researchers may ask questions on activities of daily living in order to gather more information as part of the trial. In these cases questionnaires may be used to measure physical symptoms and practical aspects of daily living, such as exercise, school and social activities, as well as to find out how someone’s emotions or mental state are affected. Some parents said that they could not see why certain questions were being asked of them or their child.
 

The questions in the questionnaire they had to complete weren’t about diabetes. It was more to do...

The questions in the questionnaire they had to complete weren’t about diabetes. It was more to do...

Age at interview: 41
Sex: Female
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 It is literally just as you’re at the diabetic clinic, each time you go there is a, an A4 pack of information asking you to score a series of questions related to physical health. So, what, Saskia’s health over the last month. So it would have an example question like, “Saskia’s been unable to exercise at school” and then it would be, “Never, sometimes” to, “Yes” do you know what I mean? And then it would have some things relating to how Saskia feels, like, “Saskia feels sad” or, “Saskia feels embarrassed” or, do you know what I mean? about the diabetes. She would have to answer them. She just goes through it going, “Never, never, never, never, never.”

 
So is the form just for her or for both of you?
 
There’s one for her and there’s one for me.
 
So there’s a form each.
 
And mine is more about Saskia. So she, you know, “Saskia has not had a problem with exercise” or whatever. It will be the same question, just worded slightly different for a parent as a child.
 
And do they ask at all about the information? Or is it just all about –?
 
No, it’s all about the illness. Which is why it’s a little strange to know how that information will… I suppose if they get a lot of children answering questions about, “I feel sad. I feel embarrassed. I feel problems with friends, problems at school, problems managing” then that might affect the information that they put in the pack perhaps. You know, maybe they, they’re, maybe they’re trying to find out what information needs to go in the pack. Which wasn’t really explained. It was more about the pack. But that makes more sense if it’s about what goes in it, isn’t it? It needs to be relevant to somebody who, to how the child feels, not how we think a child might feel being diagnosed with diabetes. I think that might be it.
 
 

Vicky didn’t understand how the questions in the monitoring questionnaire related to the trial...

Vicky didn’t understand how the questions in the monitoring questionnaire related to the trial...

Age at interview: 39
Sex: Female
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I mean it was funny because when we were filling the questionnaires in, quite often I did think back and think, “Well, I don’t understand what these questions have got to do with, you know, the way information is given to children with diabetes.” But, and I still don’t really understand that. I mean they’re all very useful questions to ask and it may be useful to understand over a period of six, nine months, however long it was, to understand the answers and, and how they changed in that period and how they differ from, you know, overall. But I couldn’t work out how it related to, you know, the topic, which was about the way information was given. But maybe that would have been clear if we’d have been on the other side of it.
 
What sort of questions were they?
 
Well, they were things like, “Do you get upset because you have to sort of alter your schedule at school? Or, “When you’re with your friends do you get upset because you’re different because you’ve got diabetes?” Or, and so it was, it was, there were questions around feelings and embarrassment of injecting in restaurants. And so my daughter had questions like that in her set, and we would have to answer the same sort of questions but, “Did we feel that she was embarrassed?” And also things like, “Does she find it difficult giving herself the medication?” or, “Does she complain about it being painful where she injects?” and things like that. So it was, and also I mean things like, “Does she get grumpy often? Tired often?” So all sort of symptoms related to the condition.
 
That’s interesting.
 
Yes, but, I mean it was interesting and I think that’s quite interesting, and I think it also would be interesting looking at the difference between how she views her condition and how we view her condition. Because I think there would be some useful bits and pieces to be, because I know sometimes I filled in that she often gets grumpy, because she, I think she does. But her view was that she didn’t often get grumpy [laugh]. But I don’t know. But, yes, it was difficult to sort of relate it back to what I thought the main trial was about.
 

Gary and his son took part in a randomised trial to assess hospital versus home management of newly diagnosed childhood diabetes. Gary and his son had separate questionnaires to complete and return to the researchers. (hear Danny’s story here.)
 

Completing the questionnaire at home was convenient for Gary and he would discuss the answers...

Completing the questionnaire at home was convenient for Gary and he would discuss the answers...

Age at interview: 47
Sex: Male
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Did you have to fill it in there? Or come away and fill it in?

 
No, you filled it at home, when it come through the post. It was about how, for, more for Danny, how diabetes affects him. And one for us, how it affects us.
 
So the questions were all about your son and about how you felt your son was coping?
 
How we think, yes, is he able to, you know, get around everyday life? Is he like normal? Can he do things that other children can do? And it was just a multi-choice thing. You know, poor, very good, excellent. A lot of it was excellent and very good, to be honest.
 
It didn’t take long?
 
No, no, it didn’t take long, no.
 
Easy to do. And did the questionnaires come separately then, for you and your son?
 
No. They all came in one envelope. There was just one for, one for us as parents and one for Danny.
 
Did, did you share at all? Did you share information or have a look?
 
Yes. We had a look at Danny’s once he’d filled it in, and he had a look at ours. And we pretty much both agreed. Because we all know what he can do and what he can’t do, so there was nothing difficult about it.
 
Did your wife fill in any of the questionnaires as well or was it just yourself?
 
Well, I filled them in, and I just read the questions out to her. And we like, you know, more or less agreed in, on the same thing. You know, it just says, you know, “Can Danny is Danny mobile as well as other non-diabetic children?” We both more or less say, “Yes, excellent.” You know, we, we more or less said the same thing for each question. And, except the odd one or two when you think, “Oh, you know, maybe he’s not so good at this as he should be. Oh, we’ll just put very good instead of excellent” you know. So, yes, we had, discussed every question. But we both knew what we were going to; we more or less both came up with the same answer.
 
That’s good. What happens if it had been different?
 
I don’t know. We, we give examples of why it was, there was one or two where we didn’t agree. We’ll say, “Well, what about that time when, you know, he did this or he couldn’t do that?” And we’re both, “Oh, just tick fair for that one then.”
 
 

 

From the age of 16 years, your child can give consent to take part in a trial. Alison’s son has cystic fibrosis and has taken part in many trials since the age of seven (hear Robert’s story here). More recently he has consented to take part in a gene therapy trial and as Alison says, sometimes it is useful if parents know what is involved.
 

Having a good relationship with her son has really helped Alison in supporting him through...

Having a good relationship with her son has really helped Alison in supporting him through...

Age at interview: 49
Sex: Female
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 Moving on to the Phase 1 trial which was, and this was the one that had all the information on it about, you know, some, some of the possible risks of it. And that’s what I did, you know, I have to say I do not sneak into his bedroom when he’s away or whatever, or see what’s lying around [laughter]. ”Oh just clearing up your room, oh I found this”, [laughter] so. And that, I remember having the conversation with him saying are you sure have you read it properly and, you know. And that and that one, that could be, because actually that had quite an involvement for me in the end as well which wasn’t clear at the start but, you know, he spoke about having these bronchoscopies and things. Well of course what he didn’t realise, and it was, which is good in a way for him because with all the hospital treatment he’s had over the years we’ve always just sort of made it as a normal part of life. You just get it over and done with, you do it, it doesn’t really interfere with your life or rather your life goes on around it. So he missed, even though he had hospital, hospitalisations and things, he didn’t miss that much school because to him it was normal to be ill. That was normal for him so we would just carry on and carry on and do things unless he was really, really unwell and really couldn’t get out of bed, life went on, doing it. So he had to go for these bronchoscopies and other things and he’s “Oh I’ve got to have a general anaesthetic”, you know, “But it’s only a day, so I’ve arranged for it this day”. And I would say “Well okay I’ll just check the calendar because I’ll just see if I’m around” you know. “Well it’s alright because, you know, I’ll just go up there and I’ll catch the train home and come back” and [laughter] and “Actually Robert if you’ve had a general anaesthetic you won’t be allowed to just come home, I will have to be here to make sure I can look after you”. And just things like that. Yes so we’ve got to work out how to get you back from the hospital, and “oh”. And yes so I had to be sure enough and they said “Yes, yes you’ve got to be looked after for 24 hours” you know afterwards and things. Yes I know I do work [laughter]. And so its, I mean it’s quite refreshing in a way to have that attitude towards it. But, so I had to, yes I had to be on hand, you know, for that and of course when his voice went and I’d say “Perhaps you should tell them at the hospital”. But well no he came out of hospital two days later, went off to Belgium, and we didn’t hear from him for a week. And then on the day he arrived back, I knew he was due home that night, we had a text, no we had a phone call from a friend of his and said “Oh Robert will be arriving on such a train he can’t talk to you because he hasn’t had any voice all week”. And I’m thinking what on earth is going on, and then you find out, you know, that oh maybe 10 days after he hadn’t had a voice, not sure that this is right I think you need to ring the hospital. So it from that point of view I’ve had to be on the sidelines but still have an active role just the same.

Parents we talked to were generally very pleased with how the trial was organised. Most felt that staff running the trial were always available to ask any questions and give reassurance.
 

Jessica, a research nurse, explains how she supports parents and children throughout the trial...

Jessica, a research nurse, explains how she supports parents and children throughout the trial...

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 I have a, like a little business card that has my contact details on them people will either text me, sometimes I have texted patients as well, using texts if that’s how they function in their lives is fantastic. It’s concise and to the point. So they can either text me, they can leave a message on my voice mail or they can speak to me on my mobile if I’m available or they can e-mail me because we run our work around e-mails so. There are lots of different ways that they can communicate with us and we do have a work mobile with us all the time so that when we’re not in our office or at our desk we’re still contactable. I think so long as they know that we can be you know, obtained at, you know, at least throughout the week it’s, that’s very important. They also need to know who to contact at the weekend, if they’re involved in a complex drug study it’s very important that they know who, what is the process that they need to go through to get help if something isn’t going right for them they must know that they can’t just wait until, they mustn’t have to wait until the next day just because it’s not office opening hours. Any research study that involves medicinal product that hasn’t been tested on children will have a will have a 24 hour contact. For example if you’ve got a study that’s run locally through a hospital, if they are likely to become ill really it’s not a bad idea for the Accident & Emergency Department to know about this study. Certainly if parents know that they can contact their consultant 24 hours a day, the switchboard can get hold of them if it’s an absolute emergency. But I think they mustn’t be afraid to report anything that they’re very concerned about because the safety of the children is the most important thing.


Last reviewed September 2018.
Last updated September 2018.
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