Clinical trials: Parents’ experiences

When the trial ends: feedback of trial results

Current guidance is that, at the end of a trial, the results are made available to everyone who took part, if they want them. They should also be published so that the wider community can use them to guide decisions about treatment and care. Most parents we spoke to felt strongly that this was important, both for themselves and for their children. Parents were glad to see what their children’s contribution had led to and what it would mean for health care and other children in the future.

The research team took great care to explain the results clearly and simply that made them easy...

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Age at interview: 39

Sex: Female

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Yes, yes, it was fine. Yes, they do a very nice newsletter, it’s a double-sided newsletter, it’s very easy to read. They’ve worked very hard at making their English very plain and very clear. You know, it is very easy to read. And then you, we got the report at two years and five years. We had that sent to us. And we had a spare copy for the school, the GP, I think. We handed it to the GP who looked slightly bemused as to why she’d been given it. But, yes, and that was very, you know, readable. Everything that they’d done there, the scores, the assessment, you know, very, very clear, very readable and a very accurate picture I would say of kind of where we were really. The communication for the growth hormone is done more when we are in a clinic. I think we have had odd bits through the post. But it has been much more when we’ve been there, “This is what we’re finding. This is what we’re looking at.” So it’s not, you know, the, I can’t remember the name of the trial, the one we did for sepsis was, you know, very nicely packaged and they’ve worked extremely well, you know, and they do a really good job, you know, at doing that and making that very accessible.

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.

And I think having things written down is always a nice way to have results, as well as being told things orally, because you come back to them and you reread them and you look at them. And actually sometimes then you might have a question. And so I think you’re more likely to follow something through if something’s written down in a nice, easy to read jolly way.

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 thing for a child to grasp.

Yes, when there is no immediate benefit?

Absolutely, yes. And also the results for this we might know in two years’ time. Well, two years’ time when you’re a child is just like ages away, isn’t it, you know. So it kind of becomes a little bit meaningless. And I think that worries me a little bit. And, and that certainly would also be another factor why I wouldn’t sign up for anything else. Because I think the timescale for children is just huge. It’s, you know, very hard. And, and it’s your body, it’s, you know, which your parent is giving consent to somebody to do something to. So it is difficult, you know, and it’s very difficult. And I don’t know, you know, there must be ways of making that very appropriate because obviously, you know, trials have to go with any age.

Some parents felt that when you get the results of a trial, it gives you a sense of being part of a wider community rather than just a number.

Sometimes results were presented at a dissemination day or at a conference. Although this is a good way to present results for larger trials to larger numbers of people, Rachel could not attend the day and did not receive any written information as an alternative.

Rachel was unable to attend the dissemination day and since then has not been able to locate the...

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Age at interview: 35

Sex: Female

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The information I got afterwards, I would have preferred to have a bit more. We were invited to a dissemination day but unfortunately I couldn’t attend. But I haven’t had any feedback on the results. And I keep looking and I’m actually struggling to find it. Although I found the University website very well, it, I do remember it being quite obscure. And I’ve lost the paper and I can’t Google it. I’ve been looking for the, the trial results and I still haven’t found them. So that would be one thing that I would say. I would have preferred to have had a, actually sent a summary information about what their final conclusion was and which vaccine they’re actually using, were using. I don’t know if they still are.

Alison attended a conference at which parents were given feedback on a phase 1 gene therapy trial for cystic fibrosis. However, sometimes results may not reflect a person’s own experience.

Alison attended a conference providing feedback on a gene therapy trial. However, she felt her...

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Age at interview: 49

Sex: Female

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Yes which we did have from the, they did this conference, you know, the one they did that all parents could go to and we went with some kind of inside knowledge of it and that’s where it was interesting to see “Oh yes all 24 of them were fine with no ill effects afterwards”. And you’re thinking mmmm okay my son’s experience was slightly different to that and that’s why I said afterwards, you know, are you sure it’s not connected but I didn’t feel it was appropriate to announce that to a conference hall.

Sometimes a trial does not show any differences between the comparison groups and this can be a little disappointing, as Alison explains.

The communication and feedback was brilliant, although it was a little disappointing that the...

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Age at interview: 39

Sex: Female

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And then we got the results of those all printed out and all written up and posted to us. We had copies to give to our GP. And then the trial itself, they were brilliant at communicating actually. So you get, I think kind of two, yes, probably every six months a newsletter comes out, you know, about the number of people who’ve been recruited, what’s going on, what they thinks’ happening. They even send us Christmas cards I do believe. I think they might have stopped that now. But it, it was, the communication, you know, was really very good. And actually what they found with the antibiotics is that it doesn’t make any difference whatsoever. So that antibiotic is not going to be used in neonatal medicine. So that was quite surprising actually, because that wasn’t what we’d been led to believe. So that’s quite an interesting turn on, you know, why you need clinical trials actually to, even though everyone had a good feeling and it had been very successful in paediatric medicine, for, for neonates that wasn’t applicable. So that was quite interesting. So we had the antibiotics for nothing. But never mind. I’ll put that down to, that’s just the way it goes. That was the purpose of it.

Well, I did feel a bit kind of, I suppose a bit let down actually, because it had been such a positive thing. And I think when you’ve had a very difficult birth story or an unusual birth story or something that’s gone very wrong or something that’s not gone to plan, I think it takes a long time, if you ever do, to completely recover from that. So I think I remember a lot more and conversations and things, whereas with my other children I probably don’t have that. So, yes, you kind of can, I can remember very much people saying, you know, I remember the registrar saying, you know, “That’s brilliant. He’s been picked. That’s fine, that’s great. You can start the antibiotics tonight” you know. And, you know, all being very positive. And, and in a very drastic situation, when hospital staff are positive, that gives you hope as well, you know.

Some parents preferred written feedback to verbal feedback. Alison’s son took part in a growth hormone trial and feedback was often given verbally at clinic appointments. She reflected “Having things written down is always a nice way to have results, as well as being told things orally, because you come back to them and you reread them and you look at them. And actually sometimes then you might have a question. And so I think you’re more likely to follow something through if something’s written down in a nice, easy to read jolly way.” It was also important to have results that used appropriate language/wording that both parents and children could understand.

Most parents wanted to know the results of the trial their children had taken part in. However, occasionally parents didn’t know when the trial ended and some were unsure if they were going to receive any results, or couldn’t remember if it was mentioned in the initial information they were given. Some also said they were not particularly bothered whether they found out the trial results as Ann comments' “It doesn’t really matter. I would like to know that it’s helped somebody or that it’s helped the studies. But it makes no difference, because I know I’ve made, at least we’ve made a bit of a difference. And helped as much as we can”.

Being in the control group, Catherine didn't feel strongly about being given the trial results....

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Age at interview: 27

Sex: Female

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No, I don’t know if it had finished, I don’t know how long they were doing it for, and I suppose if it had been something different I might [noise] have been more interested in the results but at that point you know there was so much else going on for us and it wasn’t directly affecting him so I didn’t I didn’t ask to see the results.

So when you first had the information pack they didn’t tell you at what point they might contact you or give you any when the study was going to finish?

No. Well they might, it might have been on the information sheet but you know I don’t remember.

No. Do you think that’s an important thing? Do you, would you liked to have known, you said, you know it didn’t really matter?

I think it would depend again what it was, that that didn’t really matter because I you know it doesn’t it doesn’t have any implications to us what they found and it would again be totally different if it was something that did have an effect on, on us. The results of the progesterone trial that I wasn’t part of will be of interest to me because I will probably be looking at them again in the future so; it’s sort of, yeah.

Vicky will ask about the results of the trial at her next appointment.

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Age at interview: 39

Sex: Female

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Well, I guess the only thing would be maybe to explain a bit more how the questionnaires related to what they were trying to get out of the trial really. Because as I said earlier, it, sometimes I thought, “Well, I really don’t know why they’re asking this” related to the topic of the, the trial. But, so I think that would have been perhaps useful. And also the follow-up. So, you know, informing us of the outcome. Obviously we’ve only just finished, so there’s time for that to happen. But there was no mention that that would happen in the near future. And I should have asked. But, but I think that would certainly be useful for any trial.

So when is the follow-up?

Well, we go back in another three months. But I’m not sure whether the, the research lady will be there, because presumably she’ll have finished collecting all her data.

So what happens at the follow-up?

Well, at the follow-up we just have our normal appointment with the consultant. And I guess at that point if they’ve had the results of the trial then maybe things will start changing for us, you know the sort of information and things like that.

It would be nice to know the outcome of all the information collated by the researchers. Gary...

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Age at interview: 47

Sex: Male

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And have they said anything about results at all?

I don’t think they have. I’ve not heard anything, no, since we sent it off. No, I can’t say that I’ve, I know anything about results.

Do you think, do you think you would like to know though?

I would like to know what, you know, what the outcome of all this is. Because obviously we’re not the only ones doing it and, you know, I’d like, I’d like sort of like an end result to it if it has finished now. I don’t know if it has or not. So it would be nice just for like a letter to come saying, you know, what, all the information they’ve collated and what’s come out of it.

Because sometimes you might get some personal feedback, but you don’t really know how you’ve helped at, you know, overall.

Yes, yes. It would be nice, yes, it would be nice to know what’s actually happened and, you know, what, the end result of it all. It’s only natural, isn’t it? To find out, want, want to know rather.

I think it’s important as well, some parents said it’s important the children know as well.

I think, yes, I think Danny would be interested to know, because he’s done one or two interviews, not just today. I’m quite surprised how open and how much he talks about it. Because it’s not, he doesn’t talk like that, well, through everyday life, you know what I mean about his feelings and his diabetes and stuff and trials and things like that. So I was listening and, like when the other lady came a couple of weeks ago, I was quite surprised how much, how much he talked really and how much he said about his feelings and how it affected him and things like that. Because he doesn’t talk like that to us, not in everyday life. It was like he was like grown up a bit. You know what I mean?

Jane hadn’t really thought about getting the results until asked, and said: “I don’t mind. It wasn’t really discussed. I hadn’t thought about it... Yes, it’s probably important that it should be mentioned…It would be nice to know if it made any difference, wouldn’t it.”

Some parents were too pre-occupied with their children’s health to think about when they might get the results of the trial.

Some parents felt it was important that their children know that they had made a real contribution that would improve care for others. In many cases it can take time, sometimes years, before the results of a trial are published, because the findings have to be carefully analysed. Trials themselves may take years to complete. One mother was surprised to get a call asking her for further follow-up information as she thought the trial had already ended. Others commented on how a long wait can seem even longer for children.

Julie’s son was not eligible to take part in a trial but she says she would still like to know the results of the trial. She will probably keep an eye out for them: “Very often these things are reported in the media so you do find out about them a couple of years down the line.”

Laura and her baby have enjoyed taking part in the trial; she says it has been a “positive experience”. When the trial ends Laura would like to receive feedback on her baby’s progress as well as the overall results and whether they are going to extend the trial. She would also like to have some feedback on the genetic test her baby had as part of the trial and will ask at her appointment with the doctor at the end of the trial.

Laura will ask the researchers if the results will be posted on a website. She would also like to...

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Age at interview: 32

Sex: Female

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I don’t think so. But I, obviously being a new mum and not getting a lot of sleep, there might be some things I’ve forgotten. But I don’t think, I don’t think, because they, it takes a little while, doesn’t it? To collate that sort of information. And of course other people won’t be, there will have been babies starting after Beth. So I suspect it’ll take quite a few months to, to get that information in.

Is it something you would like to know?

I’d definitely like to know, to know the results, yes.

I’ll ask at the, when I, when we have the final appointment. It’s one of the things that I will ask and see whether they might put something on a website or something that we can just see. Because they’ll no doubt publish, publish the results somewhere, if, and so if they don’t provide them to me I’ll want to know where I can find them.

I’m, well, I’m actually keen to know where they’re going to go with the study next. So the, the, the lady who came to speak to us after three months did hint that they were hoping to extend the study and increase the scope of it. So I would just want to know, to know more about that and to see whether they, they had any preliminary results, I suppose. And like I say, to make sure that I could get my hands on the results wherever possible in, in the fullness of time and see, see how it had gone. Because even if the genetic test comes back and Beth wasn’t likely to get eczema, I will, or if she does get eczema at the end of it, just taking part in the study at least we’ve had a go at helping ourselves and potentially we’ve helped to get more information for other, other families with children with eczema as well. So all, in all that’s a very good thing, I think.

Last reviewed September 2018