Clinical trials: Parents’ experiences

 There was something in the literature and I, and I do believe they made me aware of, of the, any, any potential risk factor. But the risks are extremely low with this.

 And do you think because it was kind of very kind of low risk perhaps that’s one of the reasons perhaps you took part?

 Did they talk about any side effects at all?

No the side effects, yeah it said the side effects the side effects being the same as they are for the other jabs, you know just sort of the grizzly baby for a couple of days. [Right.] But I guess if you’re trying a new thing then you don’t know necessarily what the side effects are going to be do you, so, I’m not sure, I think the link between the MMR and autism is fairly anecdotal but you you’ve got to, I always think when I say that and I lecture on that and I talk to people about that at work and stuff and then I think imagine being a mum though and your baby’s healthy and then you take it for a jab and it comes back a different baby. And it may be coincidental and it may be a whole other range of factors but imagine how that would feel just living with that even if it isn’t and people telling you it isn’t would probably just make it even harder [laughs] so, yeah. It’s sort of, it’s quite controversial isn’t it [laughs].

 Yes, yes. They went through, so that’s why when she had the side effects really badly we weren’t too, we were concerned, but we knew that, to expect them so, and I think it, perhaps it was a bit more of a shock because after the first vaccine she hadn’t had any side effects. There was no redness and it was, almost a bit of a, “Oh okay.” But not a let down, but okay, so she’s actually fine with all of this, you know. There’s all this, “Oh you must contact this, and this may happen, and this may,” you know they’d gone over everything to the nth degree, and there was nothing. So when the, it happened the second time we were like, “Oh right okay, well we must,” you know, you know, we had to record her temperature and how big her, the redness was on her arm and everything, so. But yeah, no she’s absolutely fine with it.

 I was very nervous actually, just because it wasn’t for me. And children aren’t very good at expressing themselves anyway, not; they’re not very good at expressing feelings. So if you, if you could say to Toby, “Can you describe your migraine?” it would just be like, “Oh, well, it...” Because apparently you could have left-sided or right-sided, well, Toby’s is all over, all at the front. So, but when the doctor was asking him certain questions he was very vague in his answers, where an adult can be more specific. So I was quite nervous because I didn’t want Toby to feel as if he was under too much pressure in that he couldn’t relay back to me any side effects. And I, I was quite nervous about that. But it, it’s okay, because I don’t; I don’t think I gave him enough credit really. Because he seems to know. And if he feels a bit off he’ll tell me. Or if he looks a bit peaky I’ll say, you know, “Looking a bit grey today. Are you okay?” Because you can usually tell when a migraine is coming on. But, no, I think once I’d been told that the medication was fine I felt a lot more at ease. Because, like you say, when you don’t know what medications do anyway. 

 I think they need to know as well that if anything happens or they get ill at all throughout the study that we as study personnel really need to know about that. If it’s a drug study we need to stress the point that if they are ill or they’ve experienced say a side effect or a feeling that they’ve never had before that it’s really important that that is disseminated to us so that we can report it and make the right decision about, you know, how it’s affected them and make sure that they get the right treatment and that sort of thing. So that doesn’t just encompass an admission to hospital it might just be you know, a disturbance to their sleep pattern for example, that doesn’t cause anything to happen within a hospital environment. But nevertheless it’s a change to them, which is why it’s all part of communication. It’s important that they know how to contact us or they know how to contact their research, their nurse specialist for example or their, or the principal investigator because that information can be disseminated down to me and I can contact the family if necessary. That all, that all boils down to prompt reporting of adverse events, serious adverse events that sort of thing.

 Within a couple of weeks of him being on the drugs we noticed a change in Dan, and it wasn’t for the better. He, migraines, he wasn’t having any migraines, but his moods had changed. And we were a little bit, we couldn’t, Dan had changed schools at the same time, so we weren’t sure whether to put it down to the fact that he’d changed schools or whether he was getting older or whether it was the drugs. So I literally just sent a text to his nurse, saying, “Unsure". Dan seems a little bit moody.” And within twenty minutes we got a phone call. A couple of hours later Dan’s doctor rang to say, “We’ll drop his tablets down a little bit”. 

 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.

 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.

 And in fact at the hospital they did start, I know certainly by 16 he, we signed some forms that he could then consent to things or had to and it wasn’t just sort of me. So we did start that process very early on. And he was he wasn’t fazed by having to move from the paediatric department to the adult department. And although I always sort of said, you know, of course I will come with you if you want me to; you’ve got just this [laughter]. And but in the main he sort of dealt with things on his own except for, there was a few occasions when I maybe stepped in and said you really need to go to the hospital, you really need to ring them up, [laughter] you need to do this.

 Yes, yes it is and then he said I didn’t contact you from Belgium because I knew you’d just worry. So he, and then, but then you think well actually afterwards, you know, a month later when he was in, he later he went back to Uni and he’d ring me and I’d say “Your voice is still not better is it?” “Oh no it’s fine” “No I can tell it’s not better” [laughter]. I would have thought, he should have been thinking is this going to be long term damage, is that something, you know, extra, you know, that’s happened. So yes that.