Clinical trials: Parents’ experiences

 We did agree to that with a little bit of reluctance really I think on my part, thinking, “Gosh, I, oh, I really don’t know.” But we did it for a year. Which meant extra bloods being taken at certain hospital appointments, but they would take blood anyway then. It just meant that they were going to take an extra two; I think it was an extra two vials for their research. And it meant blood pressure being checked more often than they would do normally in the first year. And we had a DEXA scan where they look at your body mass. Now one of the reasons we went ahead with all this is because we live ten minutes away from a major teaching hospital, so actually turning up for appointments and agreeing to these extra things was fairly minimal in terms of effort and getting there. You know, I can park on a friend’s drive and walk with the children and we can play in the park afterwards. I mean for us it’s fairly easy, it’s as easy as it gets really. We’re not travelling miles to, to do anything. 

 Well, we’d get there, and they’d take her blood I think to check for levels it wasn’t a sort of an instant thing or it wasn’t waiting for results or, I think it was to check if she got any antibodies or anything in her bloodstream. They would then inject her with whatever it was; they were injecting her either the placebo or the proper drug and then we have to wait for the hour. And then they take more blood, whether it was also to check for levels or, but certainly it was quite, it was quite time consuming. Only, I mean it was one day every, I forget when it, there was about four to six weeks, I think there was a window which we had to go for four to six weeks, it had to be done in that time because it’s not just a one injection thing it’s a series of injections that these children get. And I think that they so it was time consuming I think the fact that I was on maternity leave helped and things. Had I been at work it would have been more of a hassle trying to fit it in but the fact that I was off, it sort of just worked out quite well, you know, so but I suppose if you had been at work and you didn’t want to take part you could have the excuse of saying sorry I’m at work [laughter] whereas I had no excuse [laughter].

 And then after two weeks, two weeks of being enrolled in this trial, I must admit I sort of delayed the start of the diet because it was so involved and because there was the paperwork to go with it and because I really wanted to do it right and I’d fought so long to get it, I kind of delayed starting it for a month until, I waited until Matthew had started the summer holidays because he was six weeks at home with me then and I could monitor him; I could watch him every minute of the day. And I cleared all the decks at home, I literally got, I had ironing piles that I got rid of, just everything and I thought, “Right, if I’m going to do this, I’m going to give it one hundred percent.” And that’s what I did. 

 I suppose something that I kind of would want to hit upon, kind of we talked a little bit about financial implications. Obviously you’re not, paid to do a trial and it’s something you do voluntarily. And that’s strange. And I wonder if you were paid to do something, whether that would change your attitude towards doing it, and whether parents should be paid. You know, is it right to be paid to take part?

I think I’d be very split. There’s a big part of me that says, “No” that you shouldn’t be giving any sort of coercion to take part in a trial. And then there’s another part of me which is the researcher saying, “But we need participants. So if that encourages participants”. But, no, I think ultimately, I think it’s unethical to provide any form of payment. So I think it has to be on a subsistence type. I don’t think it would be appropriate to ask somebody to volunteer because they think they’re getting money from it. So, so no, that’s the bit that wins. It would be, “No, I don’t.” I think its fine to provide, I think its fine to make it as easy as possible for someone to be able to take part. And if getting childcare, for example, or buses or taxis enables them to do that, then, yes, I think that’s a good idea. But I think they should just be having costs covered rather than being given payment. 

No, because it was a voluntary thing. And I wouldn’t expect it in a child anyway. And I think I wouldn’t expect it. Because I, I’ve had friends that have done clinical trials before on medication that, that isn’t on the market, and they’ll get a one, one-off fee for spending five days in hospital. This isn’t like that. This is medication that’s already being used in treatment. If we had have been offered a payment, I wouldn’t have done the trial. 

 Well what happened, we went into the whole thing not expecting any reimbursement not for travelling, anything and it didn’t matter to us. As it happened in the last appointment Will was handed an envelope which was his expenses and it was £30 and he was absolutely delighted, he was saving up for something at the time and it was totally unexpected. And I have to say that I feel personally if when they were looking for people to take part in this trial if it had said there’s a monetary reward it would have made me feel well people perhaps doing it for the right reasons. And that’s an awful thing to say but I think it was very good that it wasn’t mentioned, you know, and nobody knew until the end really.

 We’ve received some vouchers. My daughter’s received some vouchers. And I, I don’t remember them saying at the start that we would get them. But they’ve given her a voucher each time we’ve, we’ve filled the [questionnaire]

So we get our car parking fees back, which they did very, well the cheque always arrived in the post very quickly. Obviously compensating you in terms of time is slightly harder to, to quantify. And I guess like many parents you do give up chunk, chunks of your time. And I guess we’re not the only people who, you know, who would, who would say that at all, you know. You do very willingly give up big parts of your day and reorganise your day. But the bigger picture is down the line. It’s not immediately here in front of us. And so I think you have to keep that in mind and think, “Well, the treatment we’ve got actually, if somebody hadn’t been pioneering and been willing to have done this ten years ago, well, we wouldn’t be here now” you know. And that’s very much how it seems to work. 

Chris' Not for those trials, no. In fact, no, for none of them was there anything mentioned. I have to say I’ve never pursued and wouldn’t have taken it had it been. And I think they’ve probably picked that up in the past that we weren’t in that… Because it’s quite, that specialist hospital, because it deals with so many children and some of them are vastly worse condition than Sarah, I know they do have a system where you can go to, there’s like a cash office and they do give assistance. And it is notifiable around the hospital for parking and travel and things. So I think they’d be like, it, because it’s not a general hospital, I think they know it’s available if you choose to take it anyway. But we wouldn’t have bothered anyway, would we? 

 It, do you know what? I think it would have been a lot more. The hospital is quite a distance from, from where we live and it’s, it’s not been open long, so it’s in the centre of town which is quite hard to get to, especially when you have a baby that you have to drag with you as well. I think it would have been extremely difficult to get back and forth to the hospital. But because Daniel had such a good team of doctors and nurses they came here. Apart from his original, his original one, they didn’t, we went to them. And that’s where they did all his height and his weight. And then the second one, which is when we went to get his tablets, that was like visit three, we went there. But they came to the house for the other visits, to bring him his tablets and to take his empty bottles away. So, rather than having to trek, which is, and it’s a good hour drive. It probably wouldn’t be with traffic, you’re probably looking at about 25 minutes without traffic. But there’s always traffic in town. So it’s a good hour drive, and then to find parking and, it’s, it’s quite a good few hours trek round, all round. But they came here for most of it, apart from his begin-, the beginning and the end. So, and they, they phoned as well, to check on him. So they, they made it a lot more easy than what I would have thought it would have been if we would have had to do his checks at the hospital. 

 To be honest it wasn’t I kept insisting that they gave it to the children’s heart unit. Because at that stage she was having cardiology appointments about twice every two weeks and having all the echo’s and by the time we’d had cardiology appointment about six qualified people had in some way or other they had some involvement in her care. Whether they would have been a dietician or the echo lady who does the echo or the ECG lady or the cardiologist or the nurse and so getting £7 for parking £7 for petrol or something in the days when petrol prices were slightly cheaper [laughter] seemed almost to me not being, not insulting towards me but insulting towards the hospital that I would even consider taking their money when they’ve given my child so much. And they’ve got at the hospital the children’s heart units got a fund and I just said please put it in there don’t give it to me. They made me sign for it to say that they had given it to me because they still had to get me to sign so that they could put the expenses through. So it was all paid for by the drug company it wasn’t paid for by the hospital. And the nurse was seconded to the drug company she wasn’t actually employed by the hospital and but it still just didn’t feel right taking money. 

 Yeah that’s why I’m saying, yeah I think he’d quite like that, well also you see we, not that we did it for that, because we didn’t know that. When we first, after the first meeting they said, “And obviously we’ll pay your travelling expenses for doing the trial.” So, and we said, “Well make it payable to our daughter.” And it wasn’t, it was, it was minimal, it was really just to cover the petrol and the parking. And our son said, “So she’s getting paid as well as that she’s not going to die from Swine Flu”. Oh is that all you think about is it. So when the cheque come through in her name he went, “Here we go.” Yes, tiny tiny amount, but yeah. [But it’s something.] Yeah well it did, I mean but they obviously wanted you there at, they didn’t tell you that at all in the beginning that’s what they were going to pay you, so it was only after you turned up after the first one, they said that we’ll pay you a small amount for your expenses.

 Yes, oh another thing that parents do ask and I always stress and then explain to them because sometimes parents are embarrassed to ask is about travelling expenses. Because if you’re coming for a study where there’s lots of visits it may be that it costs you money to come that you wouldn’t normally spend so there may be extra visits for the study. So in the information sheet if we are offering travelling expenses it’s important that that is in there and that’s one of the things that should be in there if we are. And it may be that parents make the decision to whether they’re going to take part in the study or not on the cost incurred to them.