Clinical trials: Parents’ experiences

 I suppose, I mean, the main reason I was probably interested with the swine flu was because my son is 22 months and he, well as soon as he went to nursery we caught everything going, I mean, every little sniffle, cold, bug and I’m just and I just knew that if swine flu was going to kick off in a big way that we’d get it through George from nursery. So I thought well, you know, if I could get him vaccinated then, you know, maybe that would avoid us getting ill. And I suppose it wasn’t from my point of view so worried but more for my husband and for my parents. Because my husband is one of the at risk categories, he’s asthmatic, and so I was a bit worried about that. And also my parents, although they’re not the more elderly, they’re not supposed to be as at risk, they you know, I just thought it was a bit unfair because they kept getting ill as well [laughter]. Because my mother looks after George a couple of days a week and so, you know, everything that he gets they get too, so you know, it’s not just us so I thought well, you know, if I took part in it then, you know I might be avoiding everybody catching it.

 But he said he’d, he said he’d have a look at the information and have a read and I was still pondering it so then I sort of happened to, I came into work sort of the next day and I was setting out my lunch and we were chatting away with all of our colleagues and it was really interesting actually because there was some very negative reactions about taking part in the trial, about the swine flu vaccine and that giving it to children, using children as guinea pigs was very frowned upon. Some were very positive but the overall reaction from people when I said I was considering it was that “Well are you sure you really want to do that, you know, stick your child with something that’s not necessarily been proven?” And so that sort of put a bit of doubt in my mind. So originally I was sort of was a bit, you know, quite positive about taking part and going for the trial and then I started thinking “Maybe are they right, are they wrong” and so I thought well I’ll have a little bit more of a look into it and I spoke to my sister who also she has a science background and she was saying “Oh I’m not sure about this particular one” because the information that she’d heard through people, certainly from the people that had taken part in the Australian trial, was that they were using the same basis sort of for the actual vaccine that had been used for what we call, what they thought was a dodgy batch of MMR vaccine. So it had a very small amount of mercury preservative in it. And she said “Well that’s the thing that would really worry me about doing it, was because the basis of this vaccine, you know, hadn’t necessarily had the greatest of track records”. But, you know, this is all heresy it’s not necessarily, you know, this wasn’t from the co-coordinators. 

 So you know I wasn’t a 100% sure. I mean, but I thought mmm do I or do I not take part. And I’m still umming and erring and it’s about a week and a half later or after, after the initial invitation came round and then my husband got called up for coming in to have his own swine flu vaccine. So I thought oh well actually the urgency’s not really there now because, you know, he’s going to be covered and I thought well, you know, it is a big sort of, you know, am I doing it for the right reasons or, you know, am I thinking of George’s best interests or am I thinking of my best interests and is it, you know, is it that, is it that bad to have a little bit of flu considering we’ve had so much flu to be honest, you know, a year and a halfish say since he’s been at nursery. So I thought oh no, so I thought no, I thought actually having reviewed the information I’ve had very mixed reactions from, you know, from my family and from colleagues at work I thought no I don’t think I want to take part, so that’s my story in a nutshell [laughter].

 Yeah, well I can’t remember when I got the letter; it must have been through the G.P. because it was about a trial for a five in one vaccine, as part of the immunisation programme. I think we first got the letter when Mikey had just come home and I probably put it to one side and thought I’d look at that later because I had a new born baby at home all of a sudden having spent three and half weeks in hospital was like in chaos. And then they wrote to us again and after Mikey had came home he actually had a hernia, inguinal hernia on one side and then an inguinal hernia on the other side, so he was in an out of hospital having operations for the next eight weeks I think.

 So then all that sort of kicked off and he was quite, he was really poorly and I think they wrote to me again and just sort of looked at it and I thought you know what, I’m all for vaccinations. I work with people with post polio syndrome so I know and I’ve been to Africa and I know how they benefit everyone and I just thought this is my baby who’s been through so much and I’m just not convinced I can feel comfortable letting him have a vaccine trial, giving him five in one, why do we need to give him five in one, he can [noise] have all the ones he needs anyway and I just said no on the occasion. And he was, I mean he was back in and out of the hospital anyway so I don’t know whether we’d even been able to do it. But I guess, and you know, you hear all the horror stories about vaccines and I’m not sure that there’s an awful lot in them but I just thought why would I take that risk at this point when we’ve just got him home and we’ve just got him healthy, sort of [laughs]. I just thought I couldn’t live with myself if I made the decision that caused him a problem so.

 Well, we’d, we’d gone to the hospital for one of her routine visits with her consultant. And the clinical trial nurse came in and, and said to us that she would be a good candidate for going on this trial, could she get in touch with us afterwards? Which, we, we let her and she, you know, she phoned and she came out to the house and she went through everything. But, you see, the minute that she said it was a blood test, she just wouldn’t.

 If parents don’t want to take part in the study then you would go back to what the normal care at that hospital and that department was. And that’s something that when we’re explaining about the research, it’s something that we always explain what the alternative would be. So if you chose not to go on this study, what would happen to me and so that’s when the medical team would explain like “We think you need treatment so we would either do this or there’s this study and we would give you something on the study”.

 And when our eldest child was born there were a number of complications in the pregnancy, and our eldest child ended up being delivered at 30 weeks with a very low birth weight. So he was less than a kilo. And because of that we spent quite a long time in a neonatal unit and also in a paediatric ward, and we became suitable and eligible for a, a number of clinical trials. The first trial we were, the first trial we were offered was a trial to do with ventilators, in that because our baby was going to be very preterm and growth had stopped in pregnancy, it would seem very likely that when they delivered him he was going to need to be put on a ventilator. So we were signed up for a trial to do with types of ventilators. We were given quite a lot of information in a very short space of time which was all right. The consultant who was heading it up was absolutely lovely, made himself very available so we could ask him about lots of questions, but actually answered I think a lot of our questions, and was very reassuring that it was all kind of run-of-the-mill stuff for them. It wasn’t anything out of the ordinary. It was simply to do with one machine versus another and they just wanted to, to look at that. So we signed up and said, “Yes, that’s absolutely fine.” On reflection it was, you know, an incredibly difficult time. I had a, a very high-risk pregnancy and I was also losing a lot of blood as well as the, the problem of the baby not growing. So I actually did leave a lot of decisions to my husband. I wasn’t really in a fit state to be able to do very much. However I do feel happy that we agreed to do this. The slight problem was when our child was born he was breathing unaided, so we didn’t need to be part of the trial. So we’d had kind of a lot of information to think about and then suddenly we weren’t at the ventilating stage at all. So that was the first trial, we were happy to be part of but actually we weren’t needed. So everyone kind of went away.

 I was I was invited to take part via the Bounty e-mail newsletter and it’s the EAT study looking at babies and young children developing food intolerances and because I have some food intolerances myself it was something I was quite interested in, and so the babies had to be less than three months old I think, be completely breast fed and you had to be able to get up to London once a year. And unfortunately I didn’t qualify because my baby had three bottles of formula when he was in hospital so we were turned down.

 No I think going back to my experiences in doing psychology and things like that, you, researchers have got to have criteria, they, they’ve got to have criteria that fits because otherwise it becomes irrelevant and you can lost in data that doesn’t mean anything. It wouldn’t be fair to put me in a fertility study with other people because there’s a reason that that my outcomes would be different and so that doesn’t teach anyone anything and then that’s not useful research and it doesn’t inform future practice so it’s sort of, there needs to be eligibility criteria. Yeah, otherwise it’s not, it becomes irrelevant doesn’t it. Its, and then it, and then it doesn’t improve anything it just, sort of, becomes a pointless task of everyone collecting data that just means nothing.