Clinical trials: Parents’ experiences

 In clinical trials for adults, the adult gives consent to take part. But for children taking part in studies the situation is very different, because the consent is given by an adult parent or carer who is not themselves the person who is going to undergo the trial and the benefits and the risks. So the situation is different. And researchers need to explain that carefully to families to under-, to, ensure that they understand that. Of course parents and carers consent for their child’s care in general, and this process of consent is similar for research. But it’s important that they receive and understand carefully the written or other information that’s provided to them, so they’re clear which parts of the care are research and which parts are part of routine care. Older children who understand what is being suggested can also take part in the process of agreeing for research. We call this assent, and it’s a process whereby a child gives a positive response about taking part in research. And this concept of assent varies actually from different countries. Some countries don’t even recognise it. And the age at which assent is appropriate varies from country to country. But in general terms, assent is something, is a process that should be sought by a researcher in a child who has a, an understanding of the research process. It’s also important to recognise that this process of consent and assent is an ongoing process. It’s not just a one-off ‘yes’ at the time of signing a piece of paper. It’s ongoing through the study and can be withdrawn at any stage, and researchers will respect that. 

 Because our child has never caught up in height and weight, we were suitable, should we want, to go ahead with growth hormone treatment, which we opted to. And at that stage, once we said yes, we were then asked whether we’d take part in a clinical trial. Now that, you know, that was a slightly harder decision in many respects to make because it has been costly in terms of time really, which is why we’ve decided not to go any further with it. So our child has growth hormone treatment, treatment which is inject, he’s injected with growth hormone daily to make him grow at a normal rate. And in the first year there’s some uncertainty as to the best dosage, and models are different in America as they are from Europe. So we were part of a trial to see which dose is the best really. Now as it happens we were given the lowest dose, which is great, great for us. And so far it looks like children do very well in their first year on the lowest dose actually and don’t need to be put on a higher dose. So we went into that with a little bit of anticipation because obviously I don’t know what dose before, we, you know, what we were going to be given and I don’t, you know, like most parents you don’t want to inject your child with some synthetic growth hormone if, if you don’t need to. 

 Okay well my little girl was born at four minutes past midnight on the 23rd July 2001, and by 11.56, I remember it rather well, a nurse listened to her chest to see if she, for her well baby check to see if she could go home, and they said she couldn’t and their precise words were; “There’s something not quite right with your baby”, which is not really words a mum wants to hear, you know, after hour long of waiting and labour and things. So she was referred to a cardiologist the next day, and diagnosed with a [heart valve problem] aortic valve which is a fairly common heart condition apparently it’s the most common childhood sort of heart condition there is. It’s a big one to fix but about one in about every 100 people have one but probably don’t know that they have one, that’s what research has shown. She was sort of followed up fairly regularly at the hospital where she was born by their fantastic cardiology team. And I was then approached by one of the directors of intensive care, or the Director of Intensive Care, to see if I would take part in a trial for a drug, which name has completely escaped me, its [Res] something like that. It’s, basically it’s a drug for RSV [Respiratory Syncytial Virus] which is a respiratory virus that children get. And it had already been licensed and that for me I think is a very important part because had it not been licensed I might not have been as keen for her to take part. But because it had already been licensed I knew it was tested and safe. 

 And, and how does it feel sort of consenting for your daughter to take part in something?

 Nikki' Sarah was diagnosed as being asthmatic when she was 18 months old, and at that point we then tried a whole range of preventer inhalers but none of them seemed to get her asthma under control. And when she was about three we switched to a, a drug called Seretide. And Sarah was on very high doses of Seretide and we did have concerns about her immune system and whether it would, it would impact on it or not. And then when she was about 5 we noticed that she was ill all the time. She was constantly ill. And we mentioned it at the hospital, this was in the, the December 2008, and, and we said we were quite concerned. But they seemed to think children get viruses all the time, so it was quite normal. But we, we made a note. There was two things. We made a note from the, the December to the March when she next went back to hospital of all the times that she was ill. And, and in that time she just, she had septic tonsillitis, three lots of conjunctivitis, two chest infections, a, a vomiting bug. She was just constantly ill. And we also noticed that she, whereas the, the other children or us would, might get one of the illnesses, she would have it for a longer period of time. And the other thing that we noticed was that she was, although one of the oldest children in a, like a pre-Brownies group that she went to, she was the smallest. And we’re quite tall, so that again concerned us. So when we went back to hospital and we put all this to them, the height thing was the thing that made alarm bells ring.

 Just to give you a bit more time, I suppose, to think about it. Don’t expect to give it you, to, an answer on that day. And give you a bit more written information rather than verbal. And just a bit more time, even if you’re just sending it through the post, just give more time to think about it and read it. Yes, definitely, because I, and I’m not, I suppose I’m not alone, I don’t take a lot in just by being talked at. I do need to, definitely to read it and think about things. And, yes, I would have probably still done it. But I might have remembered it a bit more [laugh]. Well, it is and because you are there with your child and you are in that environment of where you’re going to check up how she is, your mind is at other places. Especially over the year where she’s not been 100 per cent and she’s only just in the last like three, four months got on a good level with her blood sugars. So the, at the beginning of that trial I probably was a bit like, my mind was probably somewhere else. Because I did have a lot of questions to ask, but not her, ask the doctor. So your mind is somewhere, so you probably don’t take it in like you should really. Whereas if you get a piece of information to take away, it doesn’t really matter, does it? Because you can read it at your leisure then, can’t you? And then, because my husband wasn’t there for, for any of them, because he struggles to get, you know, to these appointments. And then you’ve got time to discuss it with your partner as well then, haven’t you? And then it gives, because you sort of feel like you’re putting your child on the spot really as well, if I’m honest, because they wanted a decision there and then. Whereas if, if you go away, yes, you still probably would anyway, but it just gives her a bit of time as well, rather than just me. It gives her a bit of time to think about it as well, doesn’t it? And you talk to her as a family really then, don’t you? And what you, what you’re doing it for and what you expect to get out of it. Whereas I think until talking to you I’ve not really thought of it like that, not at all. We just did it, you know, answered the questions as best we could. And then when it finished I just, it finished. I never give it a thought after that. I think that it’s wrong that I thought like that, if I’m honest with myself. It’s wrong that I thought [mhm] until today. “What have they done with that?” I’ve not thought that at all, not at all. I mean she were a lovely nurse, really nice lady.

 How did it feel sort of being approached to take part in a trial at a time when it was kind of vulnerable?

 I think one of the things they talked about a lot was that these things quite often happen at an absolutely crunch, critical time. You know, you have a child, a baby in a neonatal unit. I mean your life quite often is in terms of crisis. How then you begin to make a decision, if you do make a decision, and how best it is to approach parents, and what information you give them and what information you don’t give them. And how much somebody needs to know is probably different to the person in the next cot. And I think also for us a big thing was how much you trusted the doctors. Which sounds an awful thing to say but, you know. And personality plays a part, you know. Is it somebody you like? And you are trusting them with your child’s life, you know, and you don’t have a choice about it. It’s a choice that’s forced upon you. And I think that has a big part to play. And I think I hinted at that at the beginning on the atmosphere that’s created. Certainly I felt more than happy with the level of care we had, which I think was what has endeared us to kind of be part of things. And, and I’m sure had that not been there then I wouldn’t. But I think trust is a huge thing, you know, a really huge thing, and how doctors build up trust with parents. Which they need to do anyway, but actually if you want a parent to sign a form you’ve got to work twice as hard at it as well.

So when he got to about, I think he was about 7, we took him again to the doctor’s and they finally referred him to the hospital and said, “Obviously it’s more than just your average headaches.” We took him to the hospital, that had just opened a new department, took him in to see one of the, the under, the younger doctors in there. They, they basically said at his, at his age there’s nothing they can do, “Try giving him Calpol.” Again we were like, but our concern was it was getting worse to the point where he wasn’t just sick for a couple of hours now; it was twenty-four hours. And he, he also had eye problems, so he was already under the hospital for that. The doctor sent us away with, and said, “Come back in three months’ time and we’ll assess him again.” And then the day after that appointment we got a phone call from the same doctor saying that, who is Dan’s trial doctor, was interested in meeting him. He wanted to, us to go back to the hospital. Would we be interested in a trial for medication as a preventative rather than….

You know, for me a decision I never made it alone; I made it with my husband. I think if I’d had to make it alone, I would have had to have, call on friends, you know, who are academics, you know, who, who do this professionally for a living, to say, you know, “Is, is this okay?” you know, “Is what I’m signing up to all right?” And I think definitely I needed to have backing of somebody behind me to feel confident and comfortable in my decision. It wasn’t something I could do by myself. And I think, I don’t know if we, yes, I, you know, I think the hospitals do encourage that really, is, you know, is a joint decision, not something you make lightly and not something that you make by yourself, but it’s something you make with somebody. And actually you’re making it for the interests of your child as well, you know. There’s a third party involved. And that’s I think, you know.

 What sort of questions did you have?

 You know from their point of view I think you know it could be quite useful, moving forward. Our thought process at the time was basically you know, if it can put a process in place that means that you know other kids that go through the same cause of events are here for less time and their time is more comfortable then that’s got to be a benefit to all, you know. It’s not, it wasn’t ever going to put Chloe in any detrimental impact, you know all it could do really would be to keep a closer eye on her as opposed to a less involved care if you like I suppose. But I guess at the end of the day if the medical world was perfect you wouldn’t need research and trial and errors and so forth. 

 I was interested in the sort of the consenting to take part really when you know you’re not sure what you’re going to have and that actual yes we’re going to take part anyway.

 What reassured you to take part?

 I think it was really it was not so much the level of risk because I think as a child; I was making the decisions when he was a child. [Yes.] There’s not a lot that they can do for children because the guidelines are much stricter I think over involving children on clinical trials. So they tended to be if they did ask you to do anything the involvement was fairly small and fairly not risk free but limited, a limited risk. As I say he mentioned the Flixotide trial well they knew that that was an established drug so it was safe but they wanted to see the, you know, whether it was actually effective. So they knew that if you took that the risk of taking that had already been investigated I guess by whoever makes it prior to it being released as a licensed drug onto the market and they were just then looking into the effectiveness of it. So I think when they are involving a child in a trial it was on a more limited risk basis. So the only decision we really made then was what kind of involvement did it have in terms of how, what tests were they asking you to do. And it was only if they were going to stick a needle into him, when we said “well thanks very much for asking but no, we’ll pass this one by”. It was only when he got older really where he needed to give permission for doing it or consent that the risks probably seemed to become slightly more increased and the actual level of commitment became a bit more increased as well.

Right so from what I can remember she was up to date with all her jabs. And the swine flu, so the swine flu was just, everyone was just hearing about it, and starting to panic. Not me panicking as such, but it was there was quite a lot of in the newspapers, a lot of I don’t know. They were just drumming it up so it was sort of like scare mongering. So we got this letter from the from the Local Health Authority asking us if we were interested in joining our youngest daughter in the study, because she fitted the age group that was required, which was six months to I think it was four years. I don’t know if I remember correctly. There was different age categories but that was the only category that was required of us. My son who was 11 at the time was desperate to join the study because he was convinced that [he] was going to die of swine flu. But he wasn’t selected, much to his annoyance. 

 Would there have been any reason for you not to have taken part?