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Clinical Trials

Deciding not to take part in a clinical trial

Everyone who is asked to take part in a trial is free to say no, and should not feel under any pressure to take part. (You are also free to leave a trial at any time and without giving a reason – see ‘Thinking about withdrawing from a trial’). We talked to several people who decided not to take part, for various reasons. These included people who had previously volunteered for other research.

 

Having already completed one trial, Harry didn’t want to join another one run by the same...

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Age at interview: 83
Sex: Male
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I was quite pleased, I was quite pleased I went back, and I was quite pleased I continued right to the end. This new one they’ve got, I’m a little bit twitchy about that one. I wouldn’t be very keen on that one.
 
Is this the new trial?
 
The new trial. I’m not, I wouldn’t be very keen on that one.
 
Did you go and find out whether you were eligible?
 
No. I said, “No, I couldn’t, I didn’t think it would be appropriate for me to.” First place their target is 140/90. That’s blood pressure. And I’m about that more or less. The other thing about it - I don’t know if this, you could turn this off at this, you could erase this one. It seems unrealistic to have been through a medical procedure that’s got your blood pressure down to acceptable levels, and then asking you to stop taking your medication and let it go up again, and start again all over with a new drug.
 
Is that what they wanted to --
 
That’s what it was, that’s as I understand it, you see, which I consider that to be procedurally correct for a medication, for a medical profession, but I would consider that to be, and especially at 84, to start jinking about with that sort of thing, they’re asking you to deconstruct your medical procedure which is found to be satisfactory and start all over again like you was from the beginning. I thought they might be happy get to people who were just started with blood pressure. That’s what I thought might have been a better thing, you see. But they was rushing to sign on for this like it was, I was looking at them and thinking, “I don’t know. Perhaps they feel comfortable coming to hospitals and having people look after them and that.”  

In a randomised clinical trial (often called an ‘RCT’), people are allocated at random to one of the treatment comparison groups, so that each group has a similar mix of people of different ages, sex and state of health and can be compared fairly with the other groups. (See also ‘What are clinical trials’, ‘Feelings about being allocated to a treatment group’ and ‘Feelings about being in a placebo-controlled trial’).

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 in about half of trials, the new treatment will turn out to be better, but in the other half it will turn out to be worse. However, individuals may feel uncomfortable with this level of uncertainty, and with the idea of being allocated at random to one treatment or another. They may feel they are being asked to make an impossible choice without enough information. Some wanted to be guided by their doctor and preferred to trust the judgement of an expert rather than be randomised, while others wanted to make their own decision. Being asked to make such choices at a vulnerable and stressful time was hard. (See also ‘Being asked about taking part in a trial’ and ‘Information and questions’).

 
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When Lesley fractured her heel, she wanted to be told by a doctor what to do. She felt being in...

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Age at interview: 54
Sex: Female
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And then this young lady came to me from [town], she said she was from [name] University, that’s what I remembered first. Then she said she’d leave me her DVD to have a look at and would I take part in this trial? And what I remember her explaining to me was that fractured, fractures to the heel you’re never too sure, really, which way to go, whether they should do surgery or just leave it, and would I watch the DVD. And I said yes, so I did that and she left it with me. I think she came back either late that evening or the next day, and asked me if I’d take part in the trial, and that I would make the decision. And as soon as she said that I thought, “Ooh, I know nothing about this. I would rather somebody who’s a consultant or is, you know, knows this field to make the decision for me.” I didn’t, I wouldn’t have wanted to make the decision at all.
 
I realised that the trial was, is important and it has to be done, and for the good of everyone else, but I’m afraid I thought, “Not on me.” I know that’s sounds awful, doesn’t it? Meanwhile because you’ve got the internet access while you’re lying in a bed, I did look at quite a bit on the internet all about - and I saw lots of things which was quite interesting - but that wouldn’t have swayed me I had made up my mind that, no, I didn’t want to make this decision. I wanted the consultant to do it, and that was it, really. And I explained that to them and off she went.
 
I suppose in a way it wouldn’t, you’d have made the decision to take part in the trial, and then the decision about what treatment you had would have been a random decision, was that what was worrying you?
 
Mm, oh yes, it was like, Oh no, no. I don’t want to, you know. I’m here, and I want someone to tell me what I ought to do.” I didn’t want to have, don’t give me choices because I might make the wrong one. 
 

Hazel felt she did not know enough about the condition or the facts of her own case to make an...

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Age at interview: 74
Sex: Female
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And I started to read about DCIS [ductal carcinoma in situ], to find out that it was a very complicated condition and that not a lot was known about it either, that because before screening - and remember this was at the time when screening was just being introduced in the early nineties - there really wasn’t a great deal. I learned that, for example, there were five subsets of it. I learned that some were, could be quite serious and could develop into invasive cancer. I learned that others were of a quite different type and would probably never ever develop into anything. And I thought, ‘Well, this is extraordinary. It’s not one disease. It’s many, it’s a whole spectrum of things, all the way from “not necessary to find it” to “perhaps it’s not such a bad idea”.’
 
And then I thought, ‘Well.’ And then there were pieces of information about size and margins and all sorts of other things. And then I realised I didn’t have the facts of my own case, another huge information lack. How much had they excised? What were the margins? What type was it? Was I oestrogen-receptor positive or negative? All these had bearing on my coming to an assessment of how serious or unserious this thing was and, more importantly, how I could set it up against the trial that they were offering, in order to judge whether I might want to participate or not. And the more I was finding out, the more I realised I couldn’t possibly give informed consent.
 
Now I ought to refer to the particular trial which had four arms and bear in mind it was after I had had the excision biopsy, complete excision of the abnormality. The, the four trial options were' nothing further, a full course of tamoxifen for five years, a full course of radiotherapy, or radiotherapy plus tamoxifen. Now this was explained to me actually in the consultation, so I knew what the four arms trials were. The first thought that flew into my head, which happened to be a pretty good thought in retrospect, was, ‘How serious is this condition? And how can they expect me to be randomised for a condition that is a non-invasive cancer?’- which I also understood, in other words it hadn’t spread into the surrounding stroma. ‘How can I be content to be randomised to such four very different arms?’ And then, of course, jumping ahead a little, when I’d found out a little more about it I realised that I could have the sort of DCIS that had the potential to develop into invasive cancer, and I might get the ‘no further’ arm. On the other hand I might get noth-, I might get nothing, or I could have a full course of radiotherapy and five years of tamoxifen for something that was never going to cause me a problem in my lifetime. So that was a couple of weeks later.
 
But even my gut instinct told me that this was a trial that I couldn’t see how I could possibly join.

By contrast, Polly decided there was not enough uncertainty to justify the trial she was asked to join, even though tamoxifen was then quite a new treatment for breast cancer. If genuine uncertainty did not exist, then the trial seemed unethical to her. (See also ‘Feelings about being in a placebo-controlled trial’).

 

Polly decided not to take part in a placebo-controlled trial of tamoxifen because she felt there...

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Age at interview: 61
Sex: Female
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I had a lumpectomy, had the bit taken out, and then I was asked if I would like to go onto a clinical trial. I’m strongly in favour of clinical trials. I think they’re the only way you can ever find out what works and what doesn’t, and I think it’s very important. So in theory I was strongly predisposed to do that, would want to help in any way I could. But when it was explained to me what the trial involved, I had deep doubts about it. The trial, basically I was being asked to be randomly put into a group of people who would not have tamoxifen, which was an anti-breast cancer drug, or into a group that would have tamoxifen, and it would just be random. So if I agreed to go on the trial I might well fetch up in the group that didn’t have it. I’d have a placebo, I’d have a little white sugar pill, and I would never know whether I’d actually had the tamoxifen or not. I knew a bit about tamoxifen and a bit about breast cancer, partly because it had been in my family. And anyway it’s the sort of subject that I was writing about and interested in. So I did a bit of investigation, rang round a few people, talked to a few people. Tamoxifen had already been widely used. There had already been a very large trial in the United States, which had shown that it seemed to have a very strong positive effect. It seemed from this large trial as if it might improve your chances of not recurring, not getting another episode of breast cancer, by about 30 per cent, which is, you know, a very strong positive effect. So I then became very worried at the idea of going into a trial where I might not be given it, and I might never know whether I’d had it or not. So I talked to the doctors about it and they said, “Well, the trouble is, you know, we do need more research. We do need more evidence to be absolutely sure. That was American research. We need British research. We need to find out more details.” But when it came to it, I felt that we already did know pretty much. And every doctor and other people and other sources I looked at, everybody was really positive about tamoxifen.
 
That particular hospital already had quite a lot of people on it. And I thought to deny myself tamoxifen for the sake of a, you know, just a rather academic study, I thought that the disbenefit to me would be much greater, really, than the extra little bit of knowledge that would be acquired on top of the knowledge they already had. I felt badly about it because, you know, obviously we need more and more knowledge as time goes on about exactly what drugs work and how well they work. But I just felt on this occasion that we already knew a lot.  

Anton was also unwilling to take part in placebo-controlled trials, and said ‘I wasn’t very keen to take the placebo, because I’m already suffering…Then I shall tell them quite up-front. “No, if you’re giving the real tablet, I will take it, but if you’re going to give me the placebo, goodbye.” I’m only volunteering because I’m suffering.’

Anton, Hazel and Polly’s experiences all show how big differences in treatment between the trial groups affected their decisions. The risk of either getting or not getting something which could make a major difference to their lives seemed too great – especially if they knew the treatments in the trial would be available for them to choose outside the trial. In cases where a new treatment is only available within a trial people may feel they have less choice. (See ‘Reasons for taking part – personal benefit’ and ‘Reasons for taking part – helping medical science and other people’). Hazel was also very concerned about the side effects of the different treatments.

Lesley also said there was something different about a trial comparing surgery with no surgery, compared to other types of intervention which were less invasive: ‘Testing some new physio afterwards, or something like that, then you think, “Well, yes, why not? I will be a trial in that.”…It’s too drastic for me to make a decision on the biggest part, but the physio bit, if you’d have said, “Well, we can do this physio, or you can do this physio, and we’ll see which is better”, I’ve got nothing to lose, have I?”

Hazel was surprised to discover how much disagreement there was among health professionals about the design of the trial and which treatments were included, which she was not told about at the time.

 

She later discovered some doctors disagreed with radiotherapy as a treatment for DCIS, and were...

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Age at interview: 74
Sex: Female
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Also there was a huge imbalance in the arms of the trial. I didn’t know this at the time, but the clinicians, quite a number of whom did not think that radiotherapy was a wise choice for DCIS*, so they only entered patients into the tamoxifen arm of the trial, comparing tamoxifen without tamoxifen. Now I didn’t know that, and yet I was labelled as prejudiced when I raised queries about radiotherapy. And I thought, ‘That’s not fair. I have a view, and it comes from a very personal viewpoint of having the disease. Clinicians seem to be allowed to have this view that they don’t like the idea of radiotherapy and yet it was kept secret from me and I’m not allowed to have it.’ [laughs].
 
So if you’d known that you could have entered a tamoxifen versus no tamoxifen arm would you have considered that differently?
 
Oh I certainly would have considered it differently. I don’t think it’s possible with hindsight to say whether I would have entered that arm or not, because I think hindsight is a very difficult thing and I would rather not go there. People usually want to press you to say, ‘Well, what would you have done?’ You know, ‘Would you have gone into that?’
 
And I would have certainly considered it. I would have given it much more consideration. And as a matter of fact when I spoke to the family about this my daughter said to me – oh, and this was actually after I’d refused to go into the trial. We then had of course had to decide what we were going to do about it, bearing in mind that we all appreciated the uncertainty of knowing what to do about it. So you have to confront this huge uncertainty head on, outside of the trial, and not just myself but the clinician as well, and your family of course, because they’re interested.

 

* DCIS is ductal carcinoma in situ, a form of breast cancer.

She noted that it was more difficult to talk to health professionals when they were in ‘researcher mode’, when she felt they may suppress their own thoughts as clinicians in order to present a ‘united front’.

 

Staff put no pressure on her to take part, but once she declined they could advise her and reach...

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Age at interview: 74
Sex: Female
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They were very even-handed, again. And again, bearing in mind what it was, I think this is quite remarkable. They were very fair about it all. And this was, this was another thing that it raised in my mind that they had to go into sort of clinician researcher mode to put the trial to me. And of course I had the contrast of how they were afterwards when I decided not to go in for the trial, because then they were in ‘normal’, in inverted commas, clinician mode - in other words asking, negotiating with me, making the decision with me, about what we’re going to do next. And it’s quite different from being a clinician researcher, but they did it very well. The explanation was clear and they were even-handed.
 
The other thing that occurred to me at the time was, when I’d found out a little more about it quite soon after, I realised there was this huge contention in the profession about what to do with this wretched disease. And I, I imagined and I think I’d heard from a nurse somewhere - I can’t quite think how. And I realised that within a team, within an institution or a clinic that was offering a trial, you could perhaps have a radiologist, and a surgeon, and a couple of breast care nurses, and anybody else you like and they might have different views on this trial. And I thought how are they going to present a sort of united front on, ‘We are doing this trial.’ Particularly as I’d found out, as is quite obvious, that this was a very contentious trial. It fascinated me to think how they could operate as a team when it was such a difficult thing.
 
I found that quite, quite interesting. And I found it to be the case. I even heard of cases, of nurses making faces at patients behind the surgeon, saying, ‘No.’ [shakes head] [laughs] And I thought, ‘Oops.’ [laughs]. 
 

Polly never felt she got a straight answer about why the trial was needed and whether the doctor...

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Age at interview: 61
Sex: Female
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I was first approached by the surgeon who’d operated on my breast and who put it all in a, in a very plain-speaking simple way, so that it was easy to understand what the proposition was. You know, “Here’s the sugar pill and here’s the tamoxifen, and we need to know more about whether tamoxifen really works or not.” I asked him quite a lot of probing questions about, “But don’t you already feel that you know quite a lot about the benefits?” And actually I thought he was slightly shifty on this. He said, “Well, yes, we do, but we don’t altogether know. We haven’t got British results, we’ve got American results, and we do need to know more.” I felt he wasn’t entirely honest about, about it.
 
So that I said, “Well, look, if I were just coming to you as a patient and you were not doing a trial and I said, ‘Should I take tamoxifen or not?’ I suspect you would say, ‘Yes.’ On the basis of what we know so far you would prescribe it to me.” At that point he sort of denied it and said, “Well, I don’t know that I would. I don’t know that we know enough.” But I felt he probably would. If he wasn’t conducting a trial, I felt he would probably have offered me the tamoxifen. In which case I thought it wasn’t totally straight. And therefore I went to talk to another doctor in another hospital and, who said, “I would prescribe it to my patients.” So I thought, “Well, really, I’d better go for the prescription.”
 
Who was it who eventually prescribed it? Did you go back to the first surgeon?
 
I went back to the first surgeon, back to the hospital. Well, by then it was no longer, as I was not on the trial, not to the surgeon, but to the person in the diagnostic unit who I’d been under in the first place, and who I continued to see every six months for check-ups and later every year for check-ups. And she prescribed it to me as I was no longer, you know, on, on the surgeon’s books as being part of the, the trial. But it was the same hospital and the same doctor that I’d originally seen for having diagnostic investigations in the first place.
 
And did you get any sense from that doctor that, that there was any question about whether or not tamoxifen was a good idea?
 
I asked her. She was discreet, because obviously she was talking about her colleague. But she said that on the whole she thought the odds were that tamoxifen was a pretty good drug and she prescribed it to me very contentedly. It wasn’t as if I had to prise it out of her. I felt that she was probably prescribing it to a lot of her patients. And so I think I made the right decision. And I think she probably did too.
 
I did push her a bit about, “Well, in that case isn’t this a rather unethical trial that lots of women may end up being denied a drug that could give them a 30 per cent improved chance?” Doctors are very discreet about dishing the dirt on their own colleagues [laughs] and I never quite got her to admit that.

Most people who had declined to take part felt their decision was respected and that there was no pressure to change their mind.

 

She felt this was a decision she had to make for herself. The research assistant accepted her...

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Age at interview: 54
Sex: Female
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It’s a decision you have to make within yourself, don’t you? You really have to decide for yourself. It’s how you feel about surgery, isn’t it? If you feel, you know, if that scares you - it didn’t me. If you want to leave it to someone else, that was me, you see, so if you consider the consultant to have the knowledge or [pause] - I don’t know. It’s a decision you have to make on your own. And I didn’t have to ask anyone else, I just knew that it’s the decision I was going to make. It was my foot, my decision, my life and this was how I was going to cope with it, that was it really.
 
And when you made that decision and told the research assistant--
 
I was quite happy.
 
What was her reaction?
 
Oh, she was alright, she was fine, you know. She didn’t try and talk me out of it or anything like that. No, she just said, “Yeah, I understood”, and that was it. I did say I was sorry because, you know, obviously she was looking for a, you know, a volunteer or whatever it was but, you know. Actually, coming to think about it now, I can remember her coming into the room and I think as she was coming towards me I knew what she was going to do and I knew what she was going to say, I literally thought, “No, I’m not doing it.” So, you know. 

Patients should certainly not feel their care will be affected by their decision. However, sometimes people do worry about this, as Elizabeth did. She knew she wanted the standard treatment, and therefore did not think it appropriate to join the trial, but was worried about how her consultant reacted.

 

Elizabeth declined to take part in a trial in early stage ovarian cancer. She felt she did not...

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Age at interview: 53
Sex: Female
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I was in the hospital and I was visited by the consultant, and the first thing he said was that I was in a good position, which was unusual because I’d been diagnosed at an early stage, but he was very keen for me to consider going on a clinical trial to see if one particular combination of drugs was preferable to what was the gold standard treatment at the time. He told me all the facts and figures about it, and gave me a sheet, told me to go away and think about it and come back to see him three weeks later with a decision as to whether I wanted to go on the trial. And I took the information away, and it was a bit of a shock because my husband hadn’t really realised that I was going to need some chemotherapy as well. And we got home and we considered all the pros and cons, and I was in two minds whether to actually have any chemotherapy at all, or not, but a midway house seemed to be just to have the ordinary treatment, rather than going on a trial.
 
My son at the time was very keen that I didn’t lose my hair, which I would have done if I’d gone on the trials section of, the trial arm of the trial. And there were a number of other reasons I chose not to go on the trial. I felt that I’d been diagnosed at an early stage, and it wasn’t appropriate that I should have any stronger medication than I was already going to be having. I also felt I needed to have something in reserve if it did come back at any stage, and I didn’t feel that I needed to go overkill with medication that I was, it was being suggested.
 

When she told the consultant her decision, he seemed angry, which made her feel vulnerable and...

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Age at interview: 53
Sex: Female
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So I went back in three weeks time. I was very, very nervous because we’d all come to a decision that it really, I didn’t feel it was appropriate for me to go on the trial. And they were – well, the consultant was quite cross with me that I’d decided not to go on the trial. The registrar I was seeing was very supportive, understood completely why I’d chosen not to go on the trial but [pause] the consultant was cross and said it was only because I was didn’t want to lose my hair, couldn’t understand why I didn’t want to take part, and I felt very, very vulnerable and very upset.
 
And it made me think that there was another side to trials, that maybe, you know, consultants wanted to get something out of it for themselves. And if it hadn’t been for the very supportive registrar I would have been very upset. It was nerve-wracking enough going up to the hospital anyway to discuss this sort of thing, but then to be met with this, this anger that I wasn’t taking part in the trial. And I understand that people do need to take part in trials, that it is important that they get results, but I didn’t think that my particular situation was particularly going to be beneficial in this trial because I didn’t feel I was a normal person - well, an average person with ovarian cancer. Most people with ovarian cancer unfortunately are diagnosed at quite a late stage, which I wasn’t, and if they were going to do a trial about this, I didn’t fit into an average ovarian cancer patient. Neither was I an average ovarian cancer patient age. But it was very hard to deal with somebody being cross with you that you’re not taking part in a trial. And I understood that I could have opted out at any stage, but it left a bit of a difficult mark on me, really.
 
Did it ever cross your mind to say yes, wait and see what you were randomised to, and then if you were randomised to the arm you weren’t happy with, to drop out?
 
Yes, it did, it did [laughs]. But I still felt that actually that, that would make people angry as well, and that even, however many times you read the bit that says that your care won’t be compromised, you still have something at the back of your mind that if you opt out of something or if you change your treatment or whatever, there is going to be, somewhere along the line, an element of somebody may be thinking, “Oh well, she opted out of the trial”, that your care might be compromised in some way.

Although at the time Elizabeth worried that her decision might affect how she was cared for, looking back she felt it had made no difference. (See also ‘Thinking about withdrawing from a trial’).

Elizabeth explained that losing her hair would have meant a real loss of identity for her, and would have upset her family too. (See ‘Side effects and queries’). Concern about side effects often influenced people’s decision not to take part. The trial Rose was in closed early because the researchers could not find enough volunteers. The research nurse told her that most people did not want to risk the added side effects of extra chemotherapy compared to the standard treatment of radiotherapy for inoperable lung cancer.

Many people mentioned media reports of the incident in 2006 when healthy volunteers in a phase 1 trial at a commercial research unit based at Northwick Park Hospital became extremely ill. No-one we talked to said they had been directly put off taking part in a trial because of this, but several people said it had made them think more carefully and might affect future decisions. (See ‘Attitude to taking part in another trial’). They also wondered if it might be putting other people off (though in fact there is no evidence that it has).

Concern about side effects was one of several factors affecting Marie’s decision.

 

The information leaflet was complicated and reading it made Marie angry. She was worried about...

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Age at interview: 69
Sex: Female
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If it was, if you were a doctor or you had medical experience, I think you would have probably read it and understood it. But it took me from one o’clock in the afternoon until six o’clock at night reading it, reading it and reading it. And in the end I decided what I wanted to query I had to mark on it, and there was quite a lot that I was querying. I wasn’t very happy that they said that one person on this particular drug, a lupus patient, had now become ill and developed leukaemia with it, and that put me off. It also said that they gave you a list of side effects it could be, but of course being a trial there were probably side effects they didn’t know about yet. It didn’t seem as though it’s been going on for long so they don’t know what was going to happen in the long term. Legal implication was that you could have your statutory rights when claiming any damage caused by the drug company, but then underneath it said quite clearly, of course, this has got to be confirmed that it was actually the drug that caused the complications in the first place, which alarm bells went. How do you fight a drug company and how do you prove it was them if you’re not well? And these are all the things I underlined but I think there were about five pages which were absolutely full of medical jargon, sort of medical information which I frankly couldn’t understand. It was a doctor talking to a doctor not a doctor talking to a patient. I class myself as reasonably intelligent but had I not been intelligent it would have been very hard to understand. And after six hours I was angry because I saw the implications. The more I read and the more I understood it the more it annoyed me.
 
But the, most of the information I think has got to be in a language which the general public can understand, not the language of a doctor. And I think that’s where they failed as well.
 
So what did you understand about the trial? Did you understand what its aims were?
 
[Laughs] I read all about it and it explained in full detail it, its claims and its aims but it then stated, as the lady doctor had already stated in the hospital, that it might not do me any good at all. If it did I wouldn’t be able to get the drug again. And also it was supposed to be the genetic make-up of the CLL [chronic lymphocytic leukaemia] that they were investigating and a lot of things that I didn’t actually, I never did understand. I rang a friend who was a consultant at Harley Street, a Nigerian doctor I was with in Nigeria, and he, I sent him a copy and he actually went through it and he said, “No way.” And he understood it.
 
He understood the medical implications of it. 
 

She didn’t like the idea that the trial could be stopped whenever they had enough data. She would...

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Age at interview: 69
Sex: Female
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And at the end of the day, it seems very, very selfish, but I was not out to give them information for other leukaemia sufferers, I was just trying to work out whether that was actually going to do me any good. I’m thinking of me and my life. And there’s no guarantee that after going through all that, lots of visits, and lots of treatment, that it was going to me any good. And secondly, which was also brought up, when I refused it, was they said they have already been doing trials in Belgium and Germany. This would refer to the fact that the trials had been going on for some time. So when they state, “What happens when the drug is withdrawn?” In a heading in the information it states that this company can withdraw this research and trials whenever they basically have enough database and information that they require. And you will then be sent back to your consultant for alternative treatment or you may decide not to have any treatment. Well, what a silly remark to make. If you’d gone through the trials because you wanted to live how are you going to refuse any further treatment if it doesn’t work? It’s not acceptable and you don’t know what kind of mess they’ve made of your body when they transfer you back to your own consultant.
 
So you didn’t feel in this instance any sense that you should be doing it to help other people?
 
I thought to begin with that this research was, the research was being done by my hospital, because it’s a research hospital. And I probably didn’t realise the implication of trials anyway and I thought that if I went on the trial and I could help somebody else by the information, apart from helping myself, it would be good. But I don’t think there is anybody that is prepared to be fighting for their life and then give it up knowing that there’s no success in it. That is too much to ask for anybody, and I think that what they could have done was, the fact that you had decided to go through all this for their information, the least they could have done was to have stated that, “We will complete the trial with you”, not abandon you when we have the information. And that basically is telling you that you’re a guinea pig, which is also not acceptable.
 

She feels you have to be desperate to go on a trial. She wants to live, so she can look after her...

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Age at interview: 69
Sex: Female
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And I think that, you know, research is brilliant and I think they’ve got to try it on somebody but I think you’ve got to know the details first. And you’ve got to be I think you’ve got to be a bit desperate before you go on a trial. And I think I was desperate because, not because I was so sick but because I’ve got a sick daughter and I wanted to live as long as I could. And I think I thought, “Oh, this is a chance”, you know. So in that way I was desperate but there are people in certain circumstances that are so desperate and I think then, I don’t think you’ve got too much to lose.
 
So you weren’t desperate enough for this particular trial?
 
No, frankly.
 
Perhaps you were offered it too early.
 
I probably if I’d been told I’d got six months to live I might have considered it but I think the emphasis on this trial was [coughs] they really didn’t have very much proof that it was going to help CLL anyway.
 

Of course, the reason for running a trial is precisely because there is no firm evidence yet that a new treatment is better than an existing treatment, even though there may be good reason to think it is promising and worth testing. However, patients facing serious illness may understandably be looking for something they hope will do them good. (See also ‘Reasons for taking part – personal benefit’).

We were not able to interview anyone close to death about trial decisions, but several people reflected on how this could affect people’s decision-making. People could see it might work in two different directions:

  • a terminally ill person might feel they had nothing to lose, so might as well give it a try and perhaps benefit future patients, or
  • a terminally ill person might feel they wanted to be left in peace

Lester reflected on these issues in relation to his son Ellis, who died of Creutzfeldt-Jakob Disease, and his own views now.

 

When his son was dying, Lester wouldn’t have wanted anything to be intrusive. He knows trials are...

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Age at interview: 59
Sex: Male
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I suppose I’d heard about trials, but I’d never really thought the issue through. Then after thirty-five years, in 2001, my eldest son, Ellis, contracted variant CJD, Creutzfeldt-Jakob disease or, as it was known at the time, the human form of mad cow disease. And we looked after Ellis - well, we, as soon as we knew what was wrong, it was inevitable he was going to die and we only had about three months between knowing that, what he had and when he eventually died. And at that time there were no trials of anything. It, it remains a disease that has an incredibly bleak outlook, it is terminal, and that’s, that’s the long and the short of it. And I suppose our strategy at that time was simply to care for him the best. Now, of course as I’ve learnt more - and this was in 2001 and we’re now in 2008 - as I’ve learnt more I wonder if, had a trial been available, I would have put Ellis down for it, or we would have done. And I don’t, I still really don’t know the answer to that. Now, when I say ‘we’, we were faced with Ellis, who couldn’t communicate, and by the time - he was a very bright young man, he was a teacher at a private school - but the way the disease goes, it quite soon cuts off your comprehension, your ability to comprehend anything and your ability to speak. So all our concerns, and when I say ‘our’ I mean myself, my wife, Wendy, and my other son, Nik, the three of us sort of basically considered what Ellis would want at every particular stage. And, as I say, there weren’t trials at that time, so we didn’t have to make that decision. But I suppose, at that moment I am I suppose unlikely to have entered him into a trial, unless I knew a heck of a lot about it. You have somebody who has only a few months to live, you’re not going to want to do anything that may be intrusive or in any way worsen their situation, cause them even a moment’s discomfort. Because I suppose at that moment and, you know, it may sound very selfish, first and foremost it wasn’t about helping other people, it was about Ellis.
 
And I guess trials are in some way about helping the individual who enters the trial, but in many respects it is also about helping the common good. Because I’m sure that without trials in the past for various things, I may not even be here now. So I owe my longevity, in part, probably to the fact that people went into clinical trials. So I sort of feel quite awkward that I had that very protective view back in those days. But, as I say, there was, there was no trial around, and our job was just to look after Ellis until he eventually died. 
 

Even with experience of helping run a trial, he is unsure if he would volunteer if he was...

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Age at interview: 59
Sex: Male
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I suppose because I’ve been involved a lot with trials from that side, I’m almost no clearer on what I’d do as an individual. I think it would be, I think it would be the nature of the trial. I often think if, for instance, I was unfortunate enough to have cancer and, you know, I think we’re all aware that a lot of the therapies for cancer are pretty horrible, the side effects are pretty grim, and I don’t think any of us can predict how we’d feel before that moment happened to us. But I think, and I’ve talked to, about this with my wife and friends, and I think if it was a case of somebody saying, “Well, you’ve got six months to live. But go on this trial and it might give you another three months, but that will be horrible” I wouldn’t do it probably. Now it’s okay for me to sit here and say that now, but would I? Would I cling to those last extra three months so hard? And knowing that, as I said, all of us should be grateful for people who go into trials because we probably wouldn’t be here if we, if they hadn’t, how magnanimous, how public-spirited would I be if it was that tough for me at that moment? Would I think about other people? I’d love to think that I would, but I can’t be sure. If it was a screening, yeah, absolutely. I’m very sort of supportive of that. And if, I suppose if it was a bit of a no-hope situation, with no known side effects, I might. One of the things, again when we look back on Ellis and think, “Well, would we have encouraged him to go into a trial?” one of the things that might have affected us was that we knew he carried a donor card. And so therefore he’d made his own decision and statement on that. Now because of the nature of his disease, his organs were, would have been not allowed for donations. But because it was a rare disease they were absolutely invaluable for medical research, after his death. So Wendy and I had absolutely no problem, you know, when people said, “Well, look, could we take some of these organs?” Absolutely no problem at all. Because we know that’s what Ellis would have wanted. But would - so therefore I suppose we’re saying, “If you carry a donor card and you can’t make a decision yourself, people around you might say, ‘Well, actually, you know, maybe it’s, that’s what he or she would have wanted’.” I think it would be quite helpful if we had a system now where we carry cards that say, “Look, if I’m knocked down by a bus or I catch something and can’t communicate, I’d, I’m very happy to go into clinical trials.” I sort of think it’s that important, really, that you know, it’s - and I would carry one, I would carry one of those.

Since his son died, Lester has become actively involved as a lay person in clinical trials and as an advocate for more public involvement in research. Hazel has also become an activist in this field, and has co-authored the book ‘Testing Treatments’ about trials (a web resource is available at www.testingtreatments.org).

Most of the people who had decided not to take part in a trial said they were still very supportive of medical research in general and might take part in a trial another time. Their decision was what felt right for them as an individual at the time. As Lesley put it, ‘In retrospect, yes, I can see why it has to be done and it’s probably been done all through the ages, and I’ve probably benefited from somebody else’s trials. But when it came to me, then, I never even thought like that. But I do understand the benefits, and it’s very good….But not then. Not in my backyard. And that’s awful, isn’t it? I was a NIMBY - I’m sure a lot of people are.’

The level of time commitment required to take part in a trial was not something which had deterred anyone we talked to from taking part. However, some had heard of other people who had said no for this reason, and it had caused some people to withdraw or think about it. (See ‘Thinking about withdrawing from a trial’, ‘Time commitment, money and practical issues’ and ‘Attitude to taking part in another trial’).
 

Last reviewed September 2018.
Last updated July 2015.

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