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Clinical Trials

Thinking about withdrawing from a trial

It is important to know that anyone can withdraw from (leave) a trial at any point, without giving a reason, and without affecting their care. Many people we talked to remembered staff making a special point of saying this, which they found reassuring. Some wanted to get this message across to other patients thinking about a trial. 

 

Tom encourages other patients to think about taking part in a trial if it is offered. You can...

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Age at interview: 63
Sex: Male
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What would you say to other people who may be watching this and who’ve been invited to take part in a trial and are thinking about it? What would your message be?
 
Give it serious consideration, get as much information from your consultant, oncologist, whoever’s talking to you about it, talk to your family about it also. And again, as I said earlier, I think a lot will depend on the individual’s prognosis and how you view the best possible treatment that you can get. The treatment won’t be any worse, because if, as I said earlier, if you feel as a person that’s it not doing you any good or if it’s making, your quality of life is being reduced by it, speak to the doctor, speak to your consultant. If they see also that it’s having serious effects and negative effects, they’ll pull you out of it. So you always have the option of stepping back from it. But do give it serious consideration, because you will be treated well. There is the aspect also that a lot of people say, “Well, if you’re in a clinical trial you get better treatment.” I don’t know if it’s a case of getting better treatment. I think probably there are more tests done on you to make sure that the drug is not having a negative effect, so in that way perhaps people think they’re getting better treated. But I was involved in doing, as a part of the working group with the NHS Quality Improvement Scotland, doing the standards, reviewing the standards for lung cancer, and also for the core cancer standards, and that was one of the things that I got them to put in it was that just because you take part in a clinical trial doesn’t mean that, if you don’t take part in a clinical trial doesn’t mean you’re not getting the best of medical attention. So you are. But no, I would seriously give it serious consideration for taking part in a clinical trial, yes.
 

It’s important to remember you can pull out at any stage and it won’t affect your care. She...

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Age at interview: 53
Sex: Female
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I think you have to remember that at any stage you can pull out of the trial, however far you’re in or how little time you’ve been in, and you have to trust people that that’s not going to compromise your care, although I do understand the concerns that people will have about that.
 
Depending on the person, I think you want to get as much information as you can about it. To keep an open mind, and not to feel intimidated or bamboozled into taking part if you don’t feel that’s right for you.
 
And just going back to that issue about your own care being compromised, you said, obviously there are some factual ways in which that might happen like you don’t get extra appointments that you get when you’re in a trial. Did you ever say, at any stage ever think that you were treated differently apart from that as the result of not taking part?
 
I think I had adequate care. I don’t think my care was compromised. I don’t think I would have personally benefited from any further investigations that I might have had if I’d been on the trial. In fact, I suppose I think you might even think that it’s even more visits to hospital and more treatments, and just when you’re beginning to recover, you know, yet more visits you might not want to. Although that’s what I’m saying now - at the time, it may be that when you’re so involved in treatment that you do appreciate that additional care. 

Although it was reassuring to know they could drop out, some people felt strongly they had made a personal commitment and ought not to withdraw if at all possible. This might be from a sense of responsibility to staff or a general feeling of duty, or because they worried about wasting resources or damaging the research. Comments included “I’d given my word”, “I don’t want to spoil their trial”, “Don’t do a runner”, “You didn’t want to let the side down”, and “One has to go ahead with it. One undertakes these things seriously.”

 

It never occurred to her to drop out of the breast screening trial. She likes to see things...

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Age at interview: 53
Sex: Female
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Did you ever think about dropping out? Because that’s quite a long time, several years.
 
No, not really. I thought, “If I’ve taken part I might as well finish it.” Yeah, no point in going halfway and then pulling out, because the research would probably flop. So no point. I think if one is to take part in anything, they should go all the way instead of leaving it halfway, because I don’t believe in unfinished business. I think you have to go to the root cause of everything, and sometimes that might get in the way. I think that’s how I am. I like to finish the things properly, not leave you in the lurch halfway.
 
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Kate advises people to think carefully about the commitment involved before they agree. If you...

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Age at interview: 38
Sex: Female
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We were informed right from the beginning what commitment there was. We were told that we could pull out at any time, but obviously they wanted us to be sure at the outset that we were prepared to make the commitment, because it was better for the study if the people are involved the whole way through. And for us it meant travelling once every two weeks up to the hospital. And we’d usually go, I’d usually go after work and it would, including travelling, take nearly three hours every couple of weeks. And it was sort of from February through to May, and it was going every two weeks in that period, and then keeping a diary through the remainder of the summer. So it was a couple of months’ worth of commitment over the summer as well. And this went on for three years. The only payment we received was to cover our travel expenses.
 

What would you say to other people who might be thinking about whether to take part in a trial?

 

Be very sure of what the possible complications are and be satisfied you are not putting yourself at risk of serious harm. The main risk associated with the hay fever trial was anaphylactic shock but the risk was very small and precautions were in place in the unlikely event it did happen. The injection was purely grass pollen – a natural substance. If it was some kind of man-made chemical I would want to be very clear on the work that had previously been done with the drug and the precautions that were in place.
 
I would also say, make sure you understand exactly what the requirements are and what the time commitment is. If you’ve got any doubt in your mind about, “Oh, I might manage it for a year” but if it’s a long study, if you’ve got doubts, then speak to the person that’s running the trial about those doubts. Because really for the benefit of any clinical research, the more consistency they can have in the subjects that they’re studying throughout the trial period the better. So if you don’t think you can do it, I’d say pull out as close to the beginning as possible. But really, you know, it is such a benefit for these researchers to be able to carry out their work and to understand better what works, what doesn’t work, I really think it’s worthwhile. 
Side effects were a common reason for thinking about dropping out. It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.
 

Angela had some distressing side effects. She told staff but kept going because she had made a...

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Age at interview: 59
Sex: Female
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And having been diagnosed, the first clinic that I went to, the first visit to the neurosurgeon was, he asked me if I’d like to do a drug entry trial which was being run from Birmingham. They’re trying to find out about - there are four commonly prescribed drugs on entry when you’ve, it’s been discovered you’ve got Parkinson’s diagnosed.
 
He rattled off the names of the four, which didn’t really mean a lot to me, except Sinemet which I’d known somebody who’d had a really bad experience with. And so I said, “Okay, what’s involved?” And he told me. He said, ‘Well, you know, we, I would prescribe something normally, you won’t know, but in this case if you’re in the trial, I’ll phone Birmingham and they will randomly allocate you a drug which you then have to agree to take for--” I think it was it was either a week or a month, I think it was only a week. “--as a minimum. You must keep taking it.” And my husband was also involved. We fill in - there’s a follow up, so that we fill in questionnaires every six months, me from my perspective and [husband] from his as carer.
 
We did, and they phoned Birmingham and I got put on Sinemet. Oh, and it was absolutely awful. I really thought I was dying. It gave me very low blood pressure, so that when I stood up I fainted or fell back down. I had lots of falls on the stairs, disorientated, slurred speech, probably like somebody totally inebriated, as you’d say, legless. And I frightened a lot of people because my, my mother, who’s dead now, but I went to her place and sat down on the sofa and of course I went to get up and I just passed out. So it wasn’t just me, it was very frightening for everybody else. However, we stuck it for the minimum, phoned and told them straight away, you know, that it was a problem. And I took it for the minimum, which I think was a week, and then went back and got changed to ropinirole, which I’m still taking now.
 
But I’d had, I think it was explained very clearly what was wanted, and obviously one hopes to get whatever it is that’s going to be the most effective. But if you’re going into a trial you can’t, you’ve got to accept the fact that you have what you’re given, you know. I mean, otherwise there wouldn’t be any point in having trials, and I am very keen on trials.
 
And when you were getting those side effects, which sounded really quite unpleasant, did you think about pulling out at that point?
 
Yes, but I knew that there wouldn’t be any point doing it if I did, so I carried on, yeah. Yes, if [laughs] it’d had been a free - [laughs] if I wasn’t in the trial - well, I wouldn’t have been on it anyway - but if it wasn’t for the trial, then I would have come off it sooner, but when you’ve made a commitment, you’ve got to honour it. I mean, you know, it’s not very comfortable, but there wouldn’t be any point in doing it, would there?
 
Had they told you could pull out if you wanted to?
 
Oh yes, yeah.
 
Yeah.
 
Yeah.
 
So it was a kind of sense of duty to them and to research and--?
 
Yes. Mm.
 
Mm, mm.
 
Yeah, it wasn’t pleasant but there was an end coming to it, wasn’t there? So, you know, it’s [laughs] you’ve got to be prepared to do these things, haven’t you, otherwise we’re not going to make any progress,
 

It was always made clear she could withdraw at any time. She thought about it because of the side...

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Age at interview: 51
Sex: Female
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It was one day I thought I would, the next day I thought I wouldn’t. It was up and down, up and down the whole time. I started off categorically, “Yes, I will go on this trial.” And the more I read about it and thought about the implications of those side effects - not just for a week or two but for a whole year - and the money side as well because, you know, you’re not offered any, anything as recompense for you losing your time off, losing time off work like that. I was very lucky I had an employer who was very on board and very supportive, very helpful. So I think it was about, it was about right really.
 
Did you ever think about dropping out while you were taking part?
 
Yes, I did. And I was told I could do that. I was told that at any point throughout the whole trial, if I decided that I’d had enough, for whatever reason, they would not, they wouldn’t want a reason, I could just pull out at any time. There was no pressure on me to continue. Although I did say to them, “Then how does that work with the trial?” Because you’re on the trial, you haven’t completed the trial, they’d then have to go back and start with somebody else. And that, and that’s one of the things that kept me going, thinking, “If I pull out, it’s been a waste of time for them as well as me. I’ve got to do it, because if I don’t, they’ve got to then find somebody else to go through what I’ve just had to go through, and I’m halfway or whatever through it.” But I did, yes. And that was purely down to the side effects. They were so debilitating at times. As a strong person, I’ve never felt that ill in all my life. You know, I said to my children that I almost felt what it was like to live to be about 100, because that’s how old I felt at times. I was so, so sort of down about all the, the other side effects.
 
FOOTNOTE' It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.
Harry almost gave up near the beginning of a trial of blood pressure medication because of side effects.
 

After the dose of the drug was increased, Harry had bad side effects. He almost gave up, but the...

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Age at interview: 83
Sex: Male
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My first experience was slightly, a slight disaster. Well, what happened was that they took my blood pressure and it was over 200, so I was in the right place. They then gave me a medication, 50mg of atenotol [atenolol] I think it was. And that was all right. And then after two or three weeks, after I’d been up there two or three times, they put me onto 100. And I woke up one morning, I thought I was having a stroke, like bands of steel round your chest, I couldn’t breathe. I thought, “Well, this is how people feel when they’re going to die” you know. So I got up and I pottered about and I thought, “Well, I’ll tidy the place up”, you know. I like to if somebody comes in. And I couldn’t think what to do. And I sat by the street door in a chair, because I thought, “Well, if I fall off the chair, somebody will see that I’m not very well.” Anyway after about half an hour it went, disappeared. So I thought, “Well, that’s, that is, that’s useful.” So I phoned ASCOT and told them about it and she said would I come up right away? So I went up there. And he, I didn’t see the same doctor that had gave me the pills, but he had a look and he said, “Well, I see you had been on 50. You went onto 100 and then you had the trouble?” And I said, “Yes.” He said, “Well, I’ll put you back on 50”, which seemed reasonable at the time. Except that once you’ve been primed with 100 and you went back to anything below it, you got 50 per cent of the reaction that you did with 100. So I, I got the same thing back again. But I thought, so I don’t know if they were a lot of apprentices up there, but they should have known about that. They should, it wasn’t a new drug, it was an old drug - unless he was trying to do something for his statistics. And I was so annoyed about it, I never went back. I thought they should have known about that. That is something I thought they should have known about. I couldn’t expect them to know that it would affect me adversely, because I’d never taken it. But once I had taken it and the pattern begin to emerge I thought he would have said. I saw it, and I don’t know nothing about medicine. Anyway I never went back.
 
Then I got a phone call. I think it was from [doctor] enquiring why I hadn’t turned up. So I explained to him what I’ve just explained. And I just had no choice other to explain it completely. No watchwords. Just tell it exactly how it happened. I said, “And quite frankly” I said, “I was a little bit alarmed about it.” I said, “Because if you look at it, I’ve come to see you quite well and finished up in a sort of personal disaster.” Anyway he explained it to me. Over an hour he was on the phone. And I was determined not to go back. But he was so, he was like he was treating me like I was somebody rare. So I thought, “Well, I must honour his concern for my welfare.” So I went back again. And he put me on another medication, that I took right the way through all the years I was in there. And it worked. So I was glad I went back. So the important thing with this is that if you go on one of these long projects, these clinical trials, don’t be discouraged if something goes wrong. Because it’s the overall picture that counts.
 
FOOTNOTE' It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.
Sometimes people felt there were some gaps in the information they had received at the start, and they might have felt differently if they had known at the outset things they learned about later. For example, David was worried by newspaper reports of possible long-term risks from the treatment he was helping to test.
 
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After he'd started the trial, there were scare stories about the type of treatment being tested....

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Age at interview: 56
Sex: Male
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Commencing the trial I was aware that the nature of the trial was genetic. I can’t recall, actually, if we were told if there might be side effects, but I remember the doctor being very reassuring that it was safe, and I wouldn’t have done it if I’d have thought it was unsafe.
 
Funnily enough, shortly after commencing the trial there was a lot of information in the newspapers to do with these kind of trials, and it was said that mouse DNA was being used to engineer, or re-engineer the DNA of some people that had certain conditions. So I was quite alarmed by this because I immediately thought, well, there must be a risk to your blood. And I was worried about leukaemia, actually – and I voiced my concern to the doctor and he reassured me that it was safe.
 
Obviously, I wouldn’t know, and I probably wouldn’t know now if there were any side effects. I don’t know. But I continued with the trial because I thought, “Well, I’m in it. I’m in it now so I might as well see it through.” So I did. But as I say, I was slightly concerned about the negative reports in the press about DNA-type clinical trials. I haven’t done one since, and certainly the unfortunate episode at - was it Northwick Park* - has probably put a lot of people off clinical trials. I would be very surprised if anything like that happened again, but I’ve not been tempted to do a clinical trial since, I must say.
 
And when all the stuff broke in the papers about concerns about using mouse DNA, you stuck with it. Did you think for a bit about giving up?
 
Well, I’d already had at least one injection, possibly two, so I thought [laughs], “Well, if there’s going to be any damage it’s already done”, so I thought I might as well stick it, you know, see it through, yeah. But I was concerned, I must say.
 
If I’d seen some of the newspaper reports prior to commencing the trial, yeah, I would have definitely had second thoughts. But as the reports only started to appear once I was a third or half-way through the trial, that’s why I thought, “Well, I might as well see it out.” But I would definitely have had second thoughts.
 
And do you think they should have said more, then, in the information?
 
Ah, possibly, yes, possibly. I mean if they genuinely believed that there couldn’t be negative side effects in any event, then okay, fair enough. But that’s not what the newspaper reports were saying. The newspaper reports were definitely putting around scare stories about it messing around with nature, you know.
 
Can you remember what they said about possible side effects or risks? They must have said something about it.
 
Well, I mean, I think they were of the nature of if it’s affecting your DNA then it could put everything into imbalance or, or - I don’t know. I’m not a scientist.
 
*FOOTNOTE' David is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. ‘First-time-in-humans’ studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans before.
 
A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
 
Danny had already warned staff she would drop out if she experienced side effects, as she had done in the past when taking tablets for high blood pressure. She felt staff did not react well.
 
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Danny stopped taking the trial tablets when she developed side effects, as she thought might...

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Age at interview: 61
Sex: Female
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Anyway, we were given stuff to read. Now I’d had an adverse reaction to a blood pressure tablet, and I can’t remember which one it was, but one of the doctors decided to put me on two, at my GP’s surgery, and I started to get a dry cough. And I realised that it had to be that. And I read - I was away in France - I read the leaflets and it said, “Dry cough”, so I stopped taking them. Now when I - my husband and myself both embarked on the trial, but he was discarded because his blood pressure wasn’t bad enough, which was really good news for him, and testament, really, to the way he looked after himself because of the previous trials. And I told them that if I got this cough - they explained to me that I would have no medication for two weeks, and I would be on a placebo, and then after two weeks I would come back and they would put me on a placebo or the medication they were trialling. That’s the best I can describe it.
 
And I told them that if I got this cough I would stop, because it was hopeless and it just got worse and worse and worse. It was terrible. So they understood that, and they said that that was fine. So basically if I hadn’t got the cough then I’d have known that I was on the placebo.
 
So after a few days I started coughing, and it built up and it built up. And I decided it was the tablets and that I couldn’t take them any more, that I was not on the placebo, I was on the other one. And so immediately - I was told I was keeping other people awake. I was coughing all night. I know I was up numerous times a night because of it. So after about a fortnight I decided that was that, that it was the tablets and I wasn’t taking them, and I had made them aware of that.
 
Anyway, again, she didn’t use the word ‘excluded’ like I’d been naughty but it was basically, “Well I’d have to go, wouldn’t I? I was no good to them”, which I suppose is what the exclusion thing is about, “You’re no good to us,” [laughs]. Rather than, “Thanks for trying. You’ve had a different experience, and maybe there might be five per cent of you that have this experience.” Because I can’t be the only one that ended up with that cough having to come off it.  
Sometimes being part of a trial involves quite a time commitment, for example attending extra appointments and tests, travelling to and from hospital, taking time off work, or spending time being interviewed or completing questionnaires. (See ‘Time commitment, money and other practical issues’, and ‘Appointments, monitoring and questionnaires’). Most people did not mind this, and many felt reassured by frequent contact with staff and even enjoyed their visits. However, it could also become burdensome. The UK Clinical Research Collaboration Booklet on Understanding Clinical Trials has a checklist to help people find out what practical issues they need to consider.
 
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Occasionally Kate and her husband found keeping appointments 'a bit of a chore', especially when...

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Age at interview: 38
Sex: Female
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It wasn’t until we were underway, and I was clearly getting a local reaction and my husband wasn’t, that we thought, you know, that is quite a commitment to make and you’re not actually, well, he wasn’t getting any benefit from it. And they didn’t make it clear at the beginning that they would make the intervention available after, at the end of the trial, if it turned out you were on the placebo. So I think he did quite well to make the commitment the whole way through and follow through on it.
 
Did he ever think about dropping out? Or did you?
 
Occasionally it was a bit of a chore. But the nurse that was running the trial tried to be as flexible as he could be. And if something came up, and we absolutely couldn’t make it in one of the weeks, then he was able to let us come in the following week. I’m not sure what impact that would have on the results or anything like that. But clearly his clinical advisers thought that it was certainly worth, you know, being slightly flexible to keep us in the trial.
 

Sarah found it quite inconvenient continuing the injections even when she was on honeymoon –...

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Age at interview: 61
Sex: Female
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And when did they tell you what the actual treatment involved, having to take these injections?
 
At the – now, I’m just trying to think - after the scan, after the results of the first DEXA scan when I went back to her. And it’s a few years ago now so I’m just desperately trying to remember the sequence of events, and so much has happened in those years.
 
This was ’02.
 
Was there ever a point when she said that to you that you thought “Ooh, maybe not, actually”?
 
[Laughs] No, I get myself so far into things, I don’t like to back out [laughs]. I didn’t want to disappoint her, because she was saying “Oh, it’s wonderful you’ve come forward, so few people have” [laughs], so you feel a bit obligated, don’t you? I do.
 
So you, you really felt kind of that you had a duty to them to --
 
Yes.
 
--to carry on? I mean it’s interesting that so few people took part. Do you think maybe that was because what they were asking was actually quite a big ask?
 
Oh, I’m sure it was, yes.
 
And if I was a bit braver perhaps I’d have said no as well [laughs]. It was just such a nuisance. I even had to go on holiday, abroad - in fact it was my honeymoon -and I had to take the injections with me and have a letter to show at customs, in case they thought I was a drug addict.

 

[Laughs] So, just tell me a bit more about the actual process of doing it. What was it like having to take these injections?
 
I really had to steel myself. Every day I had to steel myself to do it. I’ve got a bit of a big tummy anyway, but I could still feel everything, taking a lump of stomach and [gestures] - like that. Oh, swab it, of course. And oh, I don’t know, it’s making my mouth go dry. I don’t know if it’s fear or what, but I was doing that, as I say, for months before I realised that I really, really could not cope any longer.  
 
Even though the trial involved injecting herself into the stomach, which was unpleasant and uncomfortable, Sarah carried on as long as she could. But eventually she gave up – the final straw was when she began to find the smell of the injections upsetting.
 

She withdrew from the trial when a family member was taken into hospital. The smell of the...

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Age at interview: 61
Sex: Female
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I didn’t realise what it was involved in all this, because I had to inject myself, into my stomach, which I found quite a pain, because I had never injected myself before, as a lot of other people haven’t, obviously. There was - yes, so I was having to do that morning and evening to start with, twice a day, then it went on for quite a few months. I was prepared to do it so long as - then something happened in my life, a very close relative was in hospital. The smell of this - I didn’t know if it was a placebo, nobody told me if it was the real thing or a placebo, but I was pretty sure it was the real thing because it just smelt different - I just found I couldn’t do it any longer.
 
And when you went to them and said, “I’m sorry I can’t continue any more”, what was their reaction to that?
 
Oh, they were very good about it. They’re probably used to people giving up on these things.
 
There must be lots of reasons why, but I thought this was a - I know I was not that keen on it in the end, anyway, to say the least. But that was really the deciding factor was having a member of the family very ill and having to smell the hosp- - I know even working in the hospital you get used to it, but it’s just on a different level smelling this. It’s terrible. It’s just making my mouth dry and my stomach wobble.
Several people had a preference to be allocated to one particular treatment group. (See also ‘Feelings about being allocated to a treatment group’ and ‘Feelings about being in a placebo-controlled trial’). Most people carried on even if they were disappointed at first, and looking back said they were happy with their decision to continue. However, Celia now wishes she had withdrawn when she discovered she had been allocated to the group having a longer course of radiotherapy than the standard treatment. At the time, she was mainly thinking that the standard shorter course would mean fewer trips to hospital and less inconvenience. Now she thinks the extra radiotherapy might have caused her some lasting damage.
 

Celia wishes she had withdrawn from the trial. She has since found that her system seems to be...

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Age at interview: 67
Sex: Female
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And they asked me if I’d like to go into this trial where I would either have the, what they considered the normal treatment of every day for a month, or every day for two and a half weeks, except for at weekends, of course. And [coughs] it would be, you would have no choice. It would be - what’s the word? I’ve forgotten.
 
Randomised?
 
Randomised, that’s it. It’d be randomised so that I would be in one or the other. Of course, I was hoping I’d be in the two and a half days [weeks], but unfortunately I was in the full month. Previously, the consultant had said to me that some centres use the two and a half weeks as their normal standard treatment, and it did occur to me that perhaps I could drop out of the trial at two and a half weeks, and then I, you know, I’d get what I wanted [laughs]. But I didn’t do that. I carried on and had the whole lot.
 
Now, I do regret it now that I didn’t stop at two and a half weeks, because I’ve discovered since that my lymphoma is extremely sensitive to radiotherapy, because I got trouble with my salivary glands last year, and they swelled up, and they discovered there was lymphoma in them. But I already have Sjögren’s Syndrome which was affecting the salivary glands, so my glands don’t hardly produce any saliva anyway. But they swelled up. And so eventually, my consultant said, “We’ll try some radiotherapy.” So they put me down and I think it was supposed to be, as far as I remember, five sessions of radiotherapy. I went for the first session, and that night my glands swelled up even more and became extremely painful, and so I was supposed to go back the next day for the next treatment and they told me not to come to - by the morning they had, the pain had gone away so they told me they’d leave it for a bit. And eventually, I think it was about a week later, I had a second dose and luckily there were no bad effects that time. But the next day the glands were completely flat, so I didn’t need five sessions. It worked in, in two. And I mean the consultant couldn’t believe it when he saw me, how well it had worked.
 
So it’s only with hindsight now I think if I had had the courage to stop after two and a half weeks, I probably would have been perfectly all right. And also I wouldn’t have the lung damage which I’ve got now which, you know, is due to the radiotherapy. So I’ve got bronchiectasis and pulmonary fibrosis. I get very, very breathless, and I feel if I’d stopped at two and a half weeks I probably wouldn’t have been so badly affected.
 
And have you talked to anybody about how far that was related to the, the treatment?
 
Well, they’re a bit cagey about saying that it’s [laughs], it’s related to the treatment. They say it might be and it might not be. But I know it is [laughs].
 
FOOTNOTE' The radiotherapy Celia describes for Sjögren’s Syndrome took place after the trial and was unrelated to it, but it is this experience since which has led her to think that she is very sensitive to radiotherapy. This is why she feels it might have been better for her to be in the trial group having only the two and a half weeks of radiotherapy for the lymphoma.
 
Sjögren’s syndrome is an autoimmune condition, in which the body attacks its own moisture-producing glands, such as the tear and salivary glands. In some cases, other organs of the body are also affected, including the kidneys, liver, pancreas, lungs, blood vessels and brain.
Even so, Celia does not regret staying in the trial and hopes it might help reduce the amount of radiotherapy people are given in future.
 
A few people said they might have withdrawn after randomisation if they had been allocated to a group they did not want. (See also ‘Feelings about being allocated to a treatment group’). Rosamund wanted to be in the control group. She might have pulled out if she had been allocated to one of the groups having screening because she felt it was too invasive. Ronny would probably have dropped out if he had been allocated to a group receiving radiotherapy for prostate cancer.
 

Rosamund supports medical research, but it depends how invasive the different interventions are....

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Age at interview: 64
Sex: Female
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Well, my first thoughts were that I was pleased that that this trial had been organised. Ovarian cancer is known as the silent killer, and the problem with it is, that by the time people have symptoms, it’s often too late to do anything, so this is clearly an area where some kind of effective screening could, in theory, prevent many deaths. So I was pleased that the trial was happening. And I felt that I ought to take part, that I had a moral responsibility to take part. However, my second thought was, “I don’t want to be in the groups that are having these particular approaches to screening.” And that’s quite interesting, because, as somebody who has actually, you know, organised trials myself, I know that the main problem with people refusing is actually amongst people who are randomised to the control group, who are dissatisfied and want to be receiving whatever intervention it is, and my attitude was different. I wanted to be in the control group [laughs] and not in the two screening groups. So I’m not sure what I would have done had I been randomised to one of the screening groups. I think I probably would have dropped out, and I would have argued to myself that since most people, as I’ve just said, most people who drop out drop out for the opposite reason, I would just be balancing numbers.
 
Can you imagine yourself in the situation in the future where you were diagnosed with something and how you would feel about having that decision?
 
Yeah. I would feel that I needed to check out the statement, “We don’t know which treatment is best.” And if that was really true, then I think I would say, “Okay.” It’s easier I think when, you know, what your - [sighs] well, no - I mean when the choices are between different treatments that are much the same in terms of physical side effects or inconvenience or whatever. If there was a big difference, as I felt there possibly was with the ovarian cancer trial, then I think it’s more difficult. You know, if being in one group means that you’ve got to go to hospital every month [laughs] and have something which hurts, as opposed to going every six months and having something that doesn’t hurt, then it is a decision with consequences.
 

Ronny was prepared to let the computer decide which treatment he would have for prostate cancer,...

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Age at interview: 65
Sex: Male
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Did they say to you could choose which treatment you wanted or you could stay in the trial and be randomised? Is that how it worked?
 
Yes, I could have stayed in the trial, yes, and they could have sort of monitored it, you know. Or they could, I think there was radiology. I think they talked about, I think there was an eight-week course and you had to go every day for eight, you know, and they built a shield so they didn’t damage anything else around here, you know. And I thought, “Well, honestly, I don’t fancy that at all”, you know. And, as I say, there was the random surgery. And the girl, the nurse, she says, “Well, my advice, Ronny” - well, she said she can’t advise me and tell us what to do, you know. She says, “The decision’s yours.” She says, but she, once she explained how, you know, she says, “You are quite a fit bloke for your age, and I would think seriously about what you want to do. But…” And that was when I asked her. I says, “What do you normally do? Can you put it on the computer?” And I says, “Is it fairly detailed, you know, detailed what they do? And is it, you know, they didn’t just hoy [throw] it up for you because they need to do some radical surgery on somebody, you know, sort of style?” And she went away. And she came back and she says, “It’s come up radical [surgery].” And I accepted it. And that was the 25th of November. And 13th of December I was sitting up in bed doing crosswords. Unbelievable, I cannot believe it. The night sister shook her head and walked out of the ward. She said, “I don’t believe this.” [laughs].
 
So if the computer, when they did the randomised allocation to which treatment you were going to get if it had come up with one of the other treatments, how would you have felt about that?
 
I would have probably went with them on the monitored. But I didn’t quite fancy the radiology one, you know, because they had to build a shield for you. And I know it sounds petty, like, but every day for eight or nine weeks going into the hospital, you know, I just wasn’t prepared. I just didn’t fancy myself doing that, I couldn’t see myself keeping it up, you know. But I, if the computer had come up with something different I would have probably went with it apart from the radiology one. But if it said random, I would have been, well, I would have been over the moon, wouldn’t I? I would have says, “Oh, great, I don’t have to have an operation, I don’t have to come into hospital.”
 
For the monitoring?
 
Because I had a – aye. I mean I had a, I had never ever been in hospital, apart from football injuries when you’re a kid, and you know. But never stayed overnight or anything, you know, never had an operation. And I thought, “Crumbs, they’re going to take the –” you know. But, as I said, the test, you know, the survey that they were doing is the best thing that ever happened to me. Because if I had, if I had ignored the letter, say I’d said, “Oh, I’m too busy. I cannot be bothered to go round there”, you know, I would have still been walking around with it now, but it would have been five year, five years further on and it might have been even worse, you know.
 
So if you’d been allocated to the radiotherapy group, you feel you would probably have dropped out of the trial?
 
Personally, yes, yeah. I don’t think I would have went with it. I would have came out there and I would have says, “No, I’m not.” You know.
 
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Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. It is important to realise that, on average, new treatments are as likely to turn out worse as they are to turn out better than existing treatments. This means that, going into a trial, everyone, regardless of the treatment group to which the computer allocates them, must have similar chances of a good outcome. If, in spite of the treatment uncertainties that the trial has been designed to address, people would strongly prefer one of the treatments being compared, they should not volunteer for the trial.

Sometimes people may be advised to stop taking part, perhaps because the side effects are too severe, especially if the treatment seems to be having no effect. (See ‘Side effects and queries about clinical trials’).

 
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Leslie was taken off the trial by hospital staff when he became so ill he was rushed into...

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Age at interview: 75
Sex: Male
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On the 9th of June 2004 I was suddenly overcome by a dreadful shaking fit — ‘rigor’ is its medical name. Every part of my body was moving violently. I could not control it; “this is it”, I thought, “my body is closing down; this is how death comes, not peacefully in bed but with agonising violence.” Fortunately, my wife and daughter showed rather more awareness than the trial supervisor and I was quickly ambulanced, lights flashing, hooters blaring, into a specialist hospital. My wife explained what had happened over the previous months and that I was on a clinical drug trial. She had had the foresight to bring the tablets with her. As it was a ‘double blind’ trial we did not know for certain whether I had been taking Vioxx or a placebo. The drug was ‘unblinded’ and, yes, I had been using Vioxx. Then followed some very anxious hours. I was treated with intravenous steroids, antibiotics and liquids in the attempt to identify the cause of the very serious septicaemia I had contracted and to remedy the severe dehydration I was exhibiting. I was found to be hypotensive (an almost non-existent blood pressure), tachycardic (an abnormal heart action), febrile (my temperature was 104.9°), anorexic, severely dehydrated and in sepsis. Blood samples were taken hourly to determine what treatment was appropriate and my condition was eventually brought under control. I have nothing but the highest praise for all those involved at the hospital — they saved my life and they comforted my wife and gave her hope. 
 
I was left not only with enduring memories of a period I would rather forget but also with a more potent legacy of my time on the trial — an incurable disease, ulcerative colitis. 
 
Of course, my story does not end there. When I saw my GP after being discharged from hospital she seemed to be genuinely sorry for what had happened. She said that she had made a terrible mistake and she had alerted other local GPs to the dangers of Vioxx. She also said that she had not referred me to hospital because she had been criticised for referring too many patients. She would have referred them to the specialist hospital where the specialist GI nurse recently told me that I should have been referred at the onset of the bloody diarrhoea and that any patient with blood in their faeces will be seen within 14 days.
 

Anthea completed a 12-month trial of interferon. When the melanoma returned, she joined a trial...

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Age at interview: 58
Sex: Female
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Within eleven months of that operation I found another lump, which again they removed and did a, did some more dissection, took more lymph nodes. And they sent me again to see the consultant, and they decided then that it was faster-growing than they had anticipated. They did CT scans and it was suggested that I went on the interferon trial. That trial was you’re either - we all had four weeks of intravenous interferon, and then some of us went on for another forty-eight weeks to have three, three injections a week, which were self-administered. And we were checked every three weeks to make sure that everything was going all right. And I managed to do a full twelve months, with some side effects - feeling very tired, flu-like symptoms nearly the whole way through, but I did still manage to work. I cut my hours down. I did four days a week instead of five, but I still managed to work.
 
And they thought that had, that was, things were going well. And then I was clear, that was 2005 I had the interferon. Then in 2007, in the September, I found another lump. And they did a CT scan and they decided that the disease had spread. So they needed to do something about it, but there was no, no set medication. I was offered a trial, and I had two treatments of that trial, and I lost all my hair on that trial, had a wig. I was devastated about losing the hair, but I had a wig and most people said it looked quite normal. So that wasn’t too bad.
 
But then found after another CT scan that it wasn’t actually working because there were five lesions, and it had shrunk, started to shrink one but none of the others were shrinking. So they decided that it wasn’t worth carrying on. So I was then told, “Well, that trial’s not working.” And that is the only time that I felt really let down, because the doctor told me didn’t explain that, “Well, that one’s not working but we can try something else.” It wasn’t until I was told, “That one’s not working.” And I sat there and thought, “Where do I go from here?” And I had to ask the question, “Well, is there anything else?” And it wasn’t until I asked that question that, “Well, yes, there might be other trials, but you have to have a break.”
 
FOOTNOTE' Anthea has been in three trials. Here she is talking about the first two, a 12-month randomised trial of interferon, followed by a non-randomised trial of paclitaxel (Taxol).

Anthea herself had been determined to stay in the interferon trial despite the side effects but she knew some patients had to give up. If Taxol (paclitaxel) had worked for her she would have stayed in the trial despite the side effects.

Amanda withdrew from a trial of early intervention to prevent diabetes for a very different reason. She had been through screening and fully intended to take part, until she discovered later that trial staff had been in touch with her GP without her knowledge.
 

Amanda was surprised to find she was eligible for a diabetes prevention trial. She withdrew...

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Age at interview: 54
Sex: Female
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I’m actually a doctor and I work in public health, and I was working in [county] and I was in charge, I’d just been put in charge of the diabetes strategy there, and so it made me interested in the fact that nearby they were running a diabetes intervention trial, and it was for people who were well but who might be at high risk of diabetes, so people with a family history. So I decided to just go along because I thought “Well, it would be interesting and I’d be interested in participating, I’m interested in research.” And what happened in that trial is they, screening well members of the public, are looking for people who had high blood sugars but not, not diabetic levels, to see whether certain medications would prevent diabetes actually coming on, so people who were at high risk of developing diabetes. And what really surprised me was I actually turned out to have the high fasting blood sugar, so I - which made me eligible to go into the full trial itself. And I, I hadn’t anticipated that at all when I went into it. I was just sort of seeing what they did and you go along and you have your blood taken. And then they called me back and I had the high fasting blood sugar, which meant I was eligible for the trial. At that point they said “Where there any questions?” and so I started asking the research nurse whether there are other interventions like exercise and diet which could help, and she more or less said no, and she was very vague, wasn’t very sure, but she didn’t think there was otherwise they wouldn’t be doing this trial.
 
So I was rather upset at the lack of information that was forthcoming, having had a high fasting blood sugar, and so I decided to go off and look it up myself, and so I went on and found out that, you know, diet and exercise actually do - you know, there are other things you can do as well as taking medications. And so I was a little concerned that the level of staffing at the trial, that their staff were so poorly informed about this - which was fine, I was still going to go into the trial. And then a routine visit to my GP, you know, just to get a renewed prescription and he had in front of him a piece of paper telling him I had a high fasting blood sugar, and I was really annoyed because I had not been consented for my GP to be informed anything about this, and at that point I decided I would not go into the trial, because I just didn’t think it was ethical that they had breached my confidentiality in this way, so I just withdrew from the trial and didn’t do it.
 
Footnote' The UK Clinical Research Collaboration points out that current ethical guidance is that if you agree to take part in a clinical trial, all your trial records and any information that is collected about you will be kept confidential, in the same way as your medical records. The researchers cannot tell anyone that you are in the trial without asking you first. 
 
It is important to note that this trial was conducted some years ago before more recent guidance was introduced, but even at the time Amanda thought it was unethical to tell her GP. The UK Clinical Research Collaboration (see Resources), points out that current ethical guidance is that if you agree to take part in a clinical trial, all your trial records and any information that is collected about you will be kept confidential, in the same way as your medical records. The researchers cannot tell anyone that you are in the trial without asking you first (See also ‘Communication between different health professionals’).

Last reviewed September 2018.
Last updated July 2011

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