Clinical trials: Parents’ experiences

 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.

 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.

 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.

 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.

 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.

 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 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.

 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.

 And did Dan mind at all, doing that every day?

 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.

 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. 

 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. 

 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 when you say they enjoyed it, it, was it the, the bits they had to do at home or just the whole?

 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.”

Did you have to fill it in there? Or come away and fill it in?

 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.

 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.