I think I mean it wouldn’t dissuade me just because I said no to this particular trial I don’t think it would dissuade me from taking part in other clinical trials. If I thought they were of either benefit to the greater good or whether they were of particular benefit to me or my family but I think I’d still go through the same decision process, I’d still source out the information and make sure I was happy with the decision before I went through with anything really but I think that’s more me rather than, you know, the fact it being a clinical trial.

Yes, I would. I, I think I’m slightly, not cynical, that’s the wrong word, but maybe slightly more pessimistic, or maybe that’s a bit too strong a word, about outcome of things now, and just think, Well, we could take part in something that might show that it’s pointless And, and that’s worthwhile in itself, but not always to think that everything you do is just suddenly going to have this massive knock-on effect in medicine and open lots of doors. Which sometimes things do. But just be a bit more realistic I think or, you know.

It might benefit?

Yes, it might, yes.

And having that explained maybe at the beginning?

Yes. it’s difficult when you’ve never experienced a trial before, isn’t it, to kind of know where things go and how they go and, and, and what they do? But, yes, I think that, that would be helpful to know, you know, Sometimes we don’t find out what we set out to do. Or sometimes we have to stop a trial You know, just, maybe that’s something we could have researched more actually and had a bit of a bigger picture of. You know, you just, and again you just, it’s you and them. Which sounds awful, and that’s not how it should be. And you want to make that gap as small as possible. But it, you know, it puts you at a distance, because actually you, you have no control over it whatsoever. Which comes back to trust again, which I think is, is key. Yes, it’s the key.

I would like to think that any trials that involved possibly days, mornings, afternoons, even overnight at a hospital that by the time we’re at that stage they’re freely giving you the information, and we know roughly that yes, things can go wrong, things don’t always go according to plan. But we, I would like to think that isn’t the norm. Yes, we all know that things can go wrong and it is just bad luck. They’ve not gone out of their way to make you stay in hospital even longer because it’s not what they’ve wanted you there for. So yes, I would like to think that providing they came to me with all the information that I think is relevant they could answer all my questions, then I would be saying to Jhon, I think go for i and that he would. I would like to think he’d say yes, but I can’t make him. I don’t have that right, even though I’m his Dad. And, he’s a minor. I think he’s old enough, maybe too wise, but at the end of the day the choice is his. And I’d like him; I’d like to think that he knows that I wouldn’t put him forward for anything that was going to cause him unnecessary discomfort.

Yes, with as much information that we had yeah. We would want as much information. I mean I say yes, but you would obviously still look into it. it’s not something you, you know you just say oh yes blindly. But we would consider it again, yes.

If it had been in the early stages, when they really didn’t know much, and they hadn’t trialled it out with children, then I don’t know that we would have, because she was so, when they’re so young you’re making that decision for them, it would have, yeah I don’t that I would have necessarily have done it the same way really.

Well if the child was old enough to communicate, so just say if it had been my son who’d gone for the trial. And if he at any point had said, I don’t want to do this Then, then we would have stopped really. So I think once you get to about four or five. When they can tell you they don’t want to do something, even if it’s because they don’t like the colours of the nurse’s uniform, it could be something really trivial, or, they don’t like the hospital or something, then you would stop. Because there’s no point in putting your child through distress just because you feel that, you know, even if you tried to reason with them, no I wouldn’t do that, no.

Yes, I would consider anything again, yes, to help other people, definitely.

And what about if it was like a treatment?

It would, yes, I would consider anything. And I think, you know, with diabetes a lot of it is about progressive treatment and trying to change things. And, you know, we manage on the existing regime, but we’re always reading about stuff. So if that needed people to, and I could make a decision and had enough information, then I would consider it. Obviously, with Saskia’s views on board.

Yes, yes, yes. I don’t know how it would be if it was something, you know, because diabetes is, is, although the actual illness, you know, they have to inject themselves, they have toSo it’s all very well somebody saying, You have to do i but they have to do it, don’t they? it’s their body. So if it was something like that and she didn’t want to do it, then I’d have to really consider. Even if I felt that it was going to help other people and maybe help us in, sometime in the future, but she didn’t want to do it, then we probably wouldn’t do it. I think it’s bad enough having their illness as it is without being forced to do something you don’t want to do, that you don’t need to do. If you don’t need to do it, then her view would be, Why But she might, she might take a pragmatic view. She, you don’t know unless you’re faced with it, do you? She might think, Oh, well, that might help me in the future. So if I don’t do it and nobody does it, we won’t get a better way of dealing with the insulin or whatever

And is there a time when you might stop your child taking part in a clinical trial?

Well, the, the only time I’d stop it is if my son, my son obviously didn’t want to. And that, that would be the only time. Because obviously if he doesn’t want to do it I can’t force him to. it’s, it’s his decision. But, you know, obviously if it’s going to help him, I couldn’t see why he wouldn’t.

And would you take part in another one as your son gets older?

Well, yes, to see, yes, because obviously, obviously when he’s older, because he’s only like, obviously he’s, well, he’s 8, or would have been like 6, well, 6½ say, so obviously when he gets older it’s to see the change in the way everything’s gone. So, yes, I would like him to do it when he’s older. Because that’s how, you know that’s how the, the doctors learn and, you know, that’s how they work it like. Because from when he was a, like 6½ and when he next gets it done, how so much is done on it. Like he’s, obviously he’s had to have more insulin, he’s had to have less, certain things like that. You know, it all, it all helps.

Nikki’ I think it, I think it would depend. I think we would get, gather all the information is what we tend to do [isn’t it?] and say, you know, What’s it about? Why, why are we doing it? How invasive is it And, you know, for the likes of Sarah you –

Chris’ What are the national and personal benefits? What’s the broad benefit and what’s our benefit?

And again we would talk to Sarah if it was about Sarah doing a trial. Because, you know, you’ve got to. You can’t just say, Yes, they’ll do i and they then get frightened or it’s something that they don’t want. Again we would gather all the information and then speak to Sarah and say, What do you think And, you know, and again if it’s invasive, well, how can you make that as pleasant as possible and, you know, not frightening or anything for the child?

Chris’ And I think if you were going to be involved in a trial that was more invasive, and there are some, you know, your child’s got an illness and they come up with a, you know, it’s invasive but we might find something ou I think then I would want, would probably really like to speak to somebody who’s been involved in something similar or look at something like this. It would really be a bit more relevant. Because we didn’t see, we knew she didn’t like her blood test, but we had both had them and seen her have them, so we both, we knew it was unpleasant but not major; something that could be dealt with even if it involved a little bit of upset. Whereas if it was more major than that and it easily could be, then I think we would have thought harder and looked into it more. Probably questioned where the results were going more and what the likely outcome was more than we did. Because in this case we saw it was a test for Sarah that gave us information and that, you know, the worst thing was going to be half an hour’s upset. Had that meant that she was going to be wearing something that was uncomfortable for weeks or taking any sort of medicine or drug, I think we would have spent longer and harder thinking about it.

Yeah, yeah, but obviously depends what it is. You know, like I said earlier if we’re looking at taking a lung then you know whatever then that’s a different kettle of fish. But as long I guess as long as it’s minimally intrusive not likely to have any have any detrimental impact or effect on her then yeah, no problem.

And now, that’s a, I mean because at the hospital where she’s seen for her heart, it’s sort of sister hospital does trials for nuts and that’s something I would take her for. They haven’t offered it to her yet but that’s a clinical trial where they do that where they rub a bit of nut on the lip and you have to, it’s all done in intensive care under very careful monitoring, and then systematically increase over a few days the exposure to nuts and that’s meant to, they have said that they probably wouldn’t offer it to her because she’s allergic to three kinds of nuts so that would be, you know, but then might peanuts which is the most severe allergy they might do. And that’s something I would consider but that would purely be for her benefit [laughter] yes, you know, that’s yes so that would be nobody else would benefit from that, that would just be her, you know.

There would, there would be a point. But I think it’s difficult to know what that point would be. Because I mean obviously a change in her treatment which may have direct effect on her health, then I think we’d sort of have to look into it more and understand more about, you know, the development of that particular drug, say, beforehand and how far they’d got and whether it was likely to be successful and, and things like that. I think, yes, anything which would have an impact on her health, then we’d consider. And I mean I don’t know what the point would be where we would say no, because obviously the only way that you get to see whether new things work is by trialling them. But obviously it’s that balance, isn’t it? Between letting somebody else do it.

Yes, that is something that we’ve thought of. And I mean you always, when you hear about a new treatment you always think, Oh, you know, when will that be available? When can we start doing that But obviously it takes a long time for that to happen. And so I think, yes, if anything came up like that then we would consider.

Yes, yes. So, yes, if you, if you take part in it you may only be helping other people and not yourself. But I suppose people who have a long-term condition perhaps understand that even that is still worthwhile doing, you know, because they understand what it’s like to live with that condition. So, you know, even if they’re helping other people. But again there’s got to be that balance between helping other people and it being detrimental to you. So, yes, I think those are the considerations.

Depending on what it was, yes. I don’t have a problem with research. I think it’s a really important part; it’s a major part actually in science. And I know through my own work, collecting data is just a must. So whatever can help in the future, I think. And I was quite surprised actually when we were told that childhood migraine hadn’t been researched. I think if it’s been about for as long as it has, I was, I was really quite shocked that it hadn’t. I thought it would have been a lot more advanced. But I do understand that there isn’t much they can do. Because, as we were told, as, as Dr explained to Toby, there isn’t physically anything wrong with the brain, it’s just the cells. So there isn’t much they can do.

One of the studies I was going to be, participate, in before we knew about my genetic problem was a progesterone trial when you when you got pregnant you’d be given progesterone. My issue with that really was I I’d had three miscarriages by then and my issue with that was that if I was in the, the placebo group I wasn’t getting the progesterone and when you’re talking about whether it’s going to help you keep a baby that’s sort of a huge, it’s not like you’re taking a you’re taking a drug to see if you think you know does it work against aspirin. it’s like if I have this drug I might keep the baby and if I don’t I might lose it and if I’m in the placebo group I won’t know and I, and that would have been a really tough call to make. As it was I wasn’t accepted because I found I had an underlying condition. So I guess it all depends, it’s like if you were saying if he had cancer and you wanted to give him chemotherapy or a placebo group why would you want your child to not have the treatment because you were in the placebo group and you don’t know and then it it’s really tough isn’t it. I guess you really have to think about each thing as you come up to it; it’s not something you can just say we’d be in or we wouldn’t be in. It would depend on the circumstances.

Yes, yes suitable things. I think for my baby I would be even less inclined to do things which required physical discomfort for him, for example taking blood tests and things like that. I’ve volunteered to do that myself with some of the studies I’ve done. When I had an MRI I had to have two cannulas inserted, you know, which is, which is mildly uncomfortable. But I would, I would think twice before I volunteered the baby for that kind of thing. I think in his case there would have to be a much more direct benefit for him for example to have blood taken than just the warm fuzzy feeling you get from helping out with research, which, which, might with research which might ultimately not have a direct impact on your own health or wellbeing.

So it’s quite a different thing isn’t it to volunteer yourself to take part than to volunteer your child to take part?

Yes I think so yes and I know that the medical and healthcare that brought him into this world and is keeping him healthy is important and it’s very often research based and so on. But I think I have a duty of care to him to think carefully about what I might be subjecting him to. And of course in the case of my baby I would also have to discuss it with his father before I volunteer him for anything. But for example I’ve I’ve volunteered him for the local university to do some psychology studies which are non invasive and usually they’re actually fun for the baby involved. Yes, yes. No I think if it was going to be uncomfortable for him, I think I’d have to be persuaded of the benefit, for example if he had a rare blood group for example and they were, there were few people they could call on for a trial then I would be more persuaded to allow a little bit of discomfort for him if it was going to be of very great benefit for a large number of people.

I think I’d encourage my older children to take part in trials if they wanted to and I think I’d explain that they wouldn’t necessarily be any personal benefit to them but you don’t know if what you’re going to do is to benefit somebody else in the future. So yes I would, I would encourage them to take part and to think of themselves as citizens with a, with a contribution to make.

Nikki:Yes, but as I say, the number from the nurse and then to the consultant that she referred us to, that, you know, that we’ve got mobile numbers, emails, everything. You know, they’ve been so approachable and nothing’s been any trouble. So, you know, we were phoning that nurse most days [weren’t we?] in between going to see the consultant and that. And, and she was great. It never felt like, you know, Oh, it’s them again. It was, Right, okay, what’s wrong? Even when we repeated questions or I’d found, you know, because she said, Don’t go on the Internet and, you know, looking at Wikipedia for adrenal insufficiency, because you’ll get terrified. But you can’t help it. You’re going to do that. You know, it, it’s like this site. If I’d have known that this site was there it would have helped us, wouldn’t it? Just to, to have that realism that somebody going through it and come out the other, the other end. Because you, you just, our world just went to pieces, didn’t it?

Chris:The continuity of the nurses from the beginning of the trial through to today, because it was that very same nurse that mentioned this process. So that, I think that, and once you’ve started again, she was in yet another trial the other day, when we went in the last time, which is to look at absorption rates from the inhaled steroid and, and deterioration from when you take it. And when we went in for one of her asthma reviews they actually took a urine sample and asked for the exact time of hydrocortisone medicine and measure and inhaled steroid time, quantity, and would they’d be looking at, for a tailing off graph, and we were trying to do that. But of course once you’ve started you tend to be more open to others, particularly if they’re what you might call non-invasive procedures, you’re more open, because you think it all helps to build a picture up.

And again Sarah knew the nurse, so she was happy that, you know, she’s helping more people now because she’s done this. And, as you say, it wasn’t invasive. It, you know, it’s over like that, isn’t it?

If it had been a change of, a different treatment, or, wanting to try a different treatment for her, would you still have been quite as keen?

Yes, I think so. I totally trusted the doctors and, you know I believed that they knew what was best for my daughter and they were all for getting her well. So if they’d, you know, recommended, I mean she did end up having another treatment as well, which was, I’m not sure, immunoglobulins or something or other, which was a pretty new treatment, tested on children with JDM (juvenile dermatomyositis). She had that as well.And then she also had another treatment, which was for side effects of the steroids, because it started to affect her bones, thinning bones. So she had Promiginate, which they give to old ladies for osteoporosis.But I guess I just trusted them and let them give what I thought was best for [daughter], you know. Because they’re the best people to help, aren’t they?

I mean would you, you know, did you ever think, Well, actually I don’t want to do i at all?

What, the trial? No, no, never, no.It was just a instinct, gut reaction, Yes, I’m happy for that Because I knew that no bad would come of it, you know. It was all confidential. And I thought even some good may, may come of it. There’s a good chance that some good may come of it. Because in the medical profession, and science and stuff like that, they’re learning things every day, aren’t they? So they’re bound to learn something from those, these results, bound to. And to me that’s good, you know. Anything they can learn about JDM is brilliant, you know, because it’s going to help kids in the future who get it.

Do you, do you support clinical trials in general?

it’s not something that I’ve ever thought about, clinical trials, at all. Because I’ve got five children, [daughter] is my fourth, and none of my other kids have ever been ill or anything like that. And, you know, I’m just a housewife. So clinical trials had not even entered my radar, you know, until my daughter.

What do you know about clinical, if you were to explain it, how would you explain your understanding of clinical trials, as that was your first experience?

I don’t, don’t really know.A lab, a whole load of blood results, a whole load of CMAS scores. And, you know, I really don’t know. I don’t have a clue. I don’t understand how it works. I, I didn’t even think of that. I just thought if it can help, then that’s it.

Studies show that most families and young people would like to be told about research that’s relevant to their condition or their family. But often health professionals, doctors or nurses are reluctant to place an extra burden of research on a family that may have a lot of other worries about the disease or their child at that time. Indeed there are studies coming through now which indicate that families who wanted to take part were not given that opportunity. it’s really important that families and young people who want to know or are interested if there are research opportunities to improve their care speak up and indicate to their doctors and other health professionals that they are interested in hearing about the research. It doesn’t mean they have to take part, but they may well want to know what’s going on and think about the opportunity to participate in that study. And doctors and nurses need to recognise that families are increasingly interested in hearing about the research opportunities and giving, being given their own choice to decide whether or not they can participate.