Clinical trials & medical research (young people)
What is involved in a trial: appointments and monitoring
The researchers went to Buddys home to take some blood and give his Menigitis C vaccine; it didn...
Katie said that everyone was really nice at the hospital and seeing the same doctors and nurses...
Being in a trial was a new experience for Joe, but all the staff were really nice and helpful.
And when I first went in I didn’t know anyone in there and I was really worried because I knew something was wrong when I got diagnosed. And, but, yes, the doctors were really nice and the nurses and stuff. And I mean I think when I was in there I trusted them, when, when I was on the trial I trusted them because they just like, they were really nice to me and they helped me and stuff. And I trust them now obviously and, yes, I think they’re really nice.
Taking the trial drug was fantastic as it saved Kay so much time compared to her usual...
Taking the extra medication with her regular tablets was easy for Ruby and she only attends...
It sounds easy to take an extra tablet once a week but on occasion Joanna did forget, but because...
Taking the injections away on holiday was worrying for Courtney; she was worried that the fridge...
Attending a one day group intervention was a great experience for Sophie. She enjoyed being with...
Meeting other young people with diabetes and sharing experiences was really beneficial to Sophie....
This was Joes first clinical trial and he was pleased to be allocated to stay in hospital for a...
As part of the trial it was about informing you about the diabetes and helping you, do you think it, the way they did it in the hospital, so I suppose some people may have had, just gone home with information, but you had information and hands-on. How did, you know, is that a good way, do you think that is the, sort of a good way, than being on your own?
Joe' Yes, I think it’s much better than being sent straight home because, well, I know that you might be more comfortable at home, but when, when you do have something like you’re not sure about, being in the hospital you can like instantly find the answer and they tell you what to do and how to do it and stuff. But at home you’d have to ring up and, you know, the problem might already be there before, before you’ve had a chance to ring up. So I think, and I felt more like I didn’t have to worry as much while I was in the hospital. Because I thought at home I’d have to worry about it more, and in the hospital they took care of me much more.
Mum' It felt safer, didn’t it?
Joe' Yes, safer, if, yes.
So a bit more reassured?
Joe' Reassured, yes.
Mum' And confident because you know you’ve got people there you can help you.
Joe' Yes. And I knew if something was to happen then I’d be fine because I was, I was in the hospital.
Mum' We didn’t like staying in, but it was the best place for, for him.
Joe' Yes, I mean I would have, I would have obviously liked to have been at home, because I don’t think anyone likes spending time in a hospital. But yes, I think it was much, much more like –
Mum' best thing, wasn’t it?
Joe' Yes, reassuring when I was in there.
Although they did let me, because I was dealing with it really well, and they said if, if you do go in, if you do get kept into hospital and you are dealing with it really well, then they, they let you go home in the daytime for dinner and stuff but you have to come back and sleep there. Which, that’s why; a good thing I can say is if you’re not worried and just deal with it, you know, they’ll let you go home for a bit.
So you weren’t kind of imprisoned or stuck there? There was a little bit of flexibility?
So that, did that put you at ease a little bit?
Joe' Yes, it did, because then I could see my family and stuff so.
I just think that the, the fact that they were so nice has helped me deal with it. Because I was just so shocked when I got diagnosed and I was worried about everything, about my, my health and my, just everything. And just the fact that they were so nice and helpful just really reassured me that I was going to be okay and everything was going to be fine.
And I just wondered if they sort of allowed that within the trial, you know, within this information giving, whether they, did they give you time to express how you were feeling?
Joe' Yes, yes, I think they did. Because, well I wasn’t always with the nurses and st
Staying in hospital as part of the trial, Joe learnt about diabetes, how to do insulin injections...
So tell me about what you had to do? So you took part, you agreed, so what, what happened then?
Joe' Well, I, as I say, I stayed in hospital for three days. And I just had to just go with like, they, they, they, they showed me how to do my injections and the, where to, where to inject, and they just, they d-, tell me to do my blood tests and stuff and –
Mum' You had to keep a record.
Joe' Yes, keep records and, which I still do. Which is really good because it’s helpful when you go back to see them. Yes, keep records and regular blood, blood tests. And just, they had to just keep an eye on me. And that was all.
Mum' And we go and see the nurse who, who put, who does the trial with us, if you like, the diabetic nurse, don’t we? Regular.
So you see her? I mean did they say, was it just, the trial, was that just for three days or did it go on longer?
I think if people aren’t coping very well with the diabetes then they have to stay in longer. But if you just cope with it really well, they, they say after three days that you can go home.
But you’re still part of the trial then as well?
Mum' Now, yes, yes. It goes on for a while, doesn’t it?
I’ve got no idea.
Mum' I think it’s about, is it? a good few months, isn’t it?
Joe' I think it was, yes.
So tell me what the trial was about then. What were they, what was, what were they doing?
Mum' It’s to see if people cope better at home or –
Joe' In a hospital.
Mum' it’s best to be in hospital.
Joe' Yes, you know, for when people get first diagnosed. Because, as I said, it was a big shock and hard to deal with at first. And the trial was just to see if people could deal better at home, you know, in their own environment and with everyone they know around them, or in hospital where they can be, ask questions.
Mum' And we found we preferred the hospital with people on hand who know about it.
Mum' Don’t we?
So you sort of, after being in the trial you kind of preferred that option?
Mum' Yes, yes
So what happened, during the three days you just stayed in and they showed you –?
Joe' Yes, they explained everything about my insulin. Like there’s NovoRapid and Levimir insulin which is, the No-, the NovoRapid is when you eat, which is, like quick acting insulin, and the Levimir is the one I have of a night. And they explained me what time to do it and stuff and when to do it and how many times to inject a day. And they, they, they went through my diet and stuff.
Mum' Saw the dietician.
Joe' We saw the dietician and she explained everything xx.
Mum' And carb counting.
Joe' And any question I had, they, they answered.
Mum' And still do, don’t they?
Joe' Yes, they still answer us.
Mum' We just have to phone up and…
It’s really good, isn’t it?
Mum' The nurse will phone
Sometimes a cannula is inserted to receive the trial drug, but Jenna says it doesnt hurt and...
R' [um] well, now I have to go once a month for about half a day or something like that.
I' And has that always been or has that changed over time?
R' [um] It’s changed, because like I had to go every two weeks for blood tests and then like once a month for the thing. So, because there’s like different parts of the trial.
R' Well, it’s just like a sharp scratch. But you don’t feel anything once it’s gone in. And it’s just quick. But sometimes they can’t find the vein and like it goes all weird. So that sort of like makes me feel a bit queasy. But it’s not really that bad if it goes right.
I' If it goes right, yes. And hopefully the nurses get it right every, nine times out of ten. And, and you’re there then for the day. How long does the drip take?
R' [um] About an hour or something like that.
M' I would say an hour and a half to two hours. Because they have to put a flush, what they call a flush through after the drip. And then you have to stay for a while after that before they take the final set of observations before you’re allowed to go home.
Ryan prefers to attend the day ward to receive the trial drug; even though he has to wait for the...
Having a central line inserted was worrying for Eden, but meeting other young people who had a...
Katie had to attend the hospital every two weeks for tests and complete a short two page...
Continued monitoring is an important part of the trial. Jenna has lots of different tests done...
The blood tests enabled the doctors to keep a close eye on Lois and make any changes to the dose...
Questionnaires may be used to assess physical symptoms as well as practical things such as exercise, school and social activities, and to find out how someone’s emotions or mental state are affected. Saskia and Danny had to complete three questionnaires as part of a trial, and Danny was also interviewed by a research nurse. Both their parents also completed separate questionnaires.
Completing the questionnaire at the clinic was easy to do and didnt take very long.
The interview at the end of the trial allowed Danny to express his feelings. He felt he could say...
Hannah would often discuss things in the questionnaire with her parents; and sometimes they...
Wearing a monitor for four days, doing a finger prick test four times a day and keeping a diary...
And this was first mentioned to me during a clinic appointment with my doctor. And she said we could arrange it at a convenient time for me. And it required for me to go and have the monitor fitted and then any time on day two, three or four I had to have an oral glucose tolerance test which is what I mentioned before. So to make it more convenient for me, I was having an annual review at the hospital, so I decided that would be the best time and I arranged it with my doctor so I went and had the monitor fitted the evening before, so after work I went to hospital and had the monitor fitted. And, this monitor, just was on the lower part of the, of my tummy, and the sensor just rested below the skin. So when I went in to have it fitted my doctor explained everything to me and then she said it had to have like a special, there’s a special device used to fit it. It maybe stung a little bit as the monitor was fitted. And once it was fitted we had to wait for about half an hour for it to settle and then once it was settled the doctor had to make sure that the monitor connected to the to the reader.
Because it had this little sensor and she had to just make sure that it was reading my the blood, the sugar levels just below my skin. And then once, once that was all set up my doctor explained what I would need to do to carry out the study which, which was three main days but I had the monitor attached for four days. So once the monitor was attached, my doctor talked me through what would happen and that basically included taking a blood sugar level from my finger prick four times a day. So she showed me how to do this because this is something I’d never done before. So I, she showed me how to do that and then she showed me how to record it, how to record my blood sugar level. And she made sure that, she actually did it to herself to demonstrate and then I could do it to myself to show that I understood. And then I had a record sheet which I had to fill in. And I had to record everything that I ate over the three/four day period. And what was really important was that I took the blood sugar level at least, the finger prick level, at least three times a day, ideally four times a day because then that matches up to the sensor.
So without the readings of my blood sugar levels from my finger prick it wouldn’t be able to accurately link, link it together with the sensor. So that was really important that I did that. So we made sure I understood how to do that.
And then over the top of the sensor was placed like a plaster or like a, just to secure it on to my skin. My doctor explained to me that it was okay to continue with all normal activities and that I could still have a shower or a bath, you know. She gave me a replacement plaster if I needed to change it over the period, over the few days. And then, and then I went away that evening and it did feel slightly uncomfortable at first and it took a little while to get used to, and even then sometimes, I’d, because it was like having something attached to me. It wasn’t big and cumbersome but I was very much aware that it was there.
Alexander was given a booklet to keep a daily record of his health including his temperature as...
Did you have to fill anything in at home about recording things?
Yes, I had to, when I, I actually still have a book I have to fill in if I have any temperatures, if I feel sick, if I have any new symptoms. I have a headache quite recent, quite often. So I have to put that, every headache I have and what pills I take for it. So there’s the rash chart too, from the old rash. If that occasionally does come up you have to scribble that in. Or the temperature chart. So you have to, if you’re ever feeling a bit ill or you’re feeling like you have a headache, you have to take your temperature and describe what’s going on there.
Will was a bit nervous about having blood samples taken, but the magic cream helped and he soon...
Last reivewed March 2017.
Last updated July 2014.