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Clinical Trials

Feelings about being allocated (randomised) to a treatment group

In some trials (especially Phase 1 and Phase 2 trials) everyone taking part will get the new treatment or intervention. (See ‘Non-randomised trial designs and other studies’).
 
However, many trials compare a new treatment with the standard or usual treatment by setting up two groups of people. One group of people, the experimental group, is given the new treatment. The other group, called the control group, is given the standard treatment. If no standard treatment exists, the control group may not be given any specific treatment or may be given a placebo. Some trials compare more than two groups, perhaps comparing a new treatment with two or more well-established treatments. (Sometimes you may hear the experimental group called the ‘trial group’ or ‘intervention group’. This can be confusing, as all the groups, including the control group, are part of the trial, and people in the control group may also be given an intervention, in the form of the standard treatment).
 

Phil explains what the blood pressure trial was comparing and how people were allocated at random...

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Age at interview: 58
Sex: Male
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Well, there were two different types of pill they were trying. There was the old type, which is a beta blocker, and some of the newer pills, I think they’re called ACE inhibitors and calcium blockers. And they were trying to see the difference between the two types, whether one was more effective, whether the new type of pills was more effective than the old type. And the other thing they were doing was looking into how important cholesterol was, controlling cholesterol. And that I’d be on a, whatever combination of pills plus a placebo, which may or may not have been a cholesterol-lowering pill. As it turned out, it was, and my cholesterol came right down. So that was another, another benefit.
 
So there were two sets of comparisons --
 
Yeah.
 
-- going on?
 
Yeah.
 
So the first one was comparing just the hypertension treatments?
 
That’s right, yes, yeah.
 
And the second one was cholesterol?
 
Yeah.
 
Okay. Did they, how did they explain which group you were going to be put in and how that was going to be decided?
 
That was totally at random. It was just like a, put your name in a hat and whichever one came out that’s what you’d be doing.
 
You’re told right at the outset that if you’ve got, if there are any problems, let them know straight away, or after the six-week period and you’ll be taken off.
 
They, they wouldn’t let you do anything that would endanger you at all. You know, your life wouldn’t be at risk. So I never felt worried unduly, you know. I wasn’t, I was quite confident that I’d be, end up on a right, right combination, yeah.
 
What do you feel about the, the kind of information that you were given at the time?
 
Well, it was explained basically what the trial was about, and the type of pills they were. It was explained to you that all the, the pills being used were all tried and tested. They weren’t completely new. You weren’t like a guinea pig to that extent. You know, the main thing was to compare the newer type of pill with the old beta blocker, and to see what sort of results they got from that, plus the, what effect the lowering of cholesterol had. Because apparently, although they knew about, about the effects of cholesterol, it had never really been properly tested in conjunction with blood pressure reduction. So, you know, the whole thing was a new, new experiment, but it was all done with using drugs that had been used at least, you know, for some time. So I was always quite happy. I always felt I was in good hands and never really worried at all, you know. 
To make sure that each group contains a similar mix of people, many trials are ‘randomised’. This means that people are allocated at random to one of the groups in the trial, often by using a computer programme. When people are randomised they have an equal chance of being in either trial group. Random allocation helps ensure we are comparing two very similar groups of patients, so if one group does better than another, it is very likely to be because the treatments being compared have different effects, and not because of differences between the people in the groups. The helpful UK Clinical Research Collaboration booklet on Understanding Clinical Trials explains these and other terms (see Resources).
 
Many of the people we talked to had been invited to take part in a randomised clinical trial or RCT. Two linked issues crop up in discussing people’s feelings' firstly, how well they understood generally what randomisation is and why it matters, and secondly how they felt about it in their own case. (See also ‘Information and questions about clinical trials’).
 
A lot of research evidence suggests that staff may find it hard to explain randomisation and that the idea confuses or worries some patients. They may feel that terms such as ‘the toss of a coin’ or ‘pulling it out of a hat’ sound too trivial for what is to them a very serious issue - even though patients we talked to used these terms themselves. One difficulty is that often people would prefer to be in one group rather than another.
 

It was an anxious time waiting to hear which trial group she was in. She’d have felt cheated if...

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Age at interview: 51
Sex: Female
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So at that point the nurse said, “Okay, we’ve got all your details. You go back out and wait in reception. We need to ring the computer base that’s dealing with it, and in about five minutes we get told whether the computer’s churned you out as one of the candidates for the trial with the drug, or one of the candidates for the trial without the drug.” At which point we were really worrying. And one of my husband’s main worries was, “What happens after all this hoo-ha and all this soul-searching if you say, ‘I want to go on the trial’ and then at the end of the day you’re on the trial without the extra drug? You’ve gone through all that for nothing.” And I said, “Well, it’s a chance I’ve got to take.” And I’m a very religious person and I feel strongly that God had a hand in that. If I was meant to have it, I was meant to have it. I was one of the lucky ones. I did go on the trial.* And that took up most of 2007.
 
And if when it had come to it, you’d been one of the people that weren’t going to get it, do you think you might have changed your mind?
 
No. I would have still gone through with it. I think I would have felt cheated. Yes, I would have still gone through with it, because I still think anything like that that helps improve the statistics for other people or the, you know, the long-term benefits for anybody else going through what I went through, it’s got to help.
 
Yeah, that’s, it’s really interesting, the motivations. There’s a kind of, there’s a mix there, isn’t there, for you of helping other people and possibly helping yourself?
 
Yes.
 
Which was stronger for you? How did you weigh up those things?
 
From a selfish point of view, it was more important for me to get this extra drug, because to my mind it was an extra bite of the cherry. If they felt I needed chemo, something else was going on. And the professor made it absolutely plain to me that I was an ideal candidate, based on my age, the fact that I didn’t smoke, I didn’t drink, I wasn’t overweight. And he said, “You are an absolutely ideal candidate for this.”
 
So based on that, I read between the lines. And I’d also asked my friend to research it and she said, “It is a very, very good drug.” It’s a very expensive drug, and it’s only been since I went on the trial that I’ve heard in the media that the specific drug I was on the trial was one that only cancer patients that go through BUPA are able to access. So I felt increasingly privileged that I had that, that drug.
 
FOOTNOTE' 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. Of course trials are done because there is a possibility that a new treatment will be better than the standard or control treatment, and it may have already been shown to work for other conditions or groups of patients. However, trials are just as likely to find that new treatments are no better, or indeed worse.
 
*People who are allocated to the control group are also in the trial, not just the people allocated to the experimental group, as Wendy explains elsewhere. 
 
Wendy was not unusual in having quite a strong preference to be in the group receiving the new treatment – in her case to get the extra drug, which she hoped would improve her chances of beating cancer. Others had a preference to be in the control group. Ronny was in a trial comparing three options (active monitoring, radical surgery or radiotherapy) for prostate cancer. He agreed to be randomised, but thought he might have dropped out of the trial if he had been allocated to the radiotherapy group. (See also ‘Thinking about withdrawing from a trial’).
 

Waiting to hear which group he was in was ‘a long few minutes’. Ronny hoped he’d be in the active...

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Age at interview: 65
Sex: Male
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Well, I knew it was only going to be a few minutes, because they went straight on to the main computer. It was a long few minutes, like, you know. And actually what happened was the computer was down when I went on it, you know. And she says, we made a joke of that. I says, “You see this?” and carrying on, and she had to go away and use another computer. And she came back and that’s how it was up, you know. I, as I said, I would have accepted, but I wouldn’t have accepted radiology. I don’t think I could have. It was, I think it was just the inconvenience – well, not the inconvenience, that’s the wrong word. It was having to go there every day for eight - and then again I said, I asked, she said, “It could come back. You could go through all that and it could still come back”, you know. And she explained the monitoring and she explained what radical surgery was, you know. She said, “Them’s your three options. You can have any one of them.” But I went with, well, I says, “Well, I’ll go for the computer”, thinking it would come up with monitoring, and that would take the decision away from me. But it didn’t. It come up with radical [surgery]. So the decision was made for us, you know, which was, in a sense, it made it easier. Because I know computers are not infallible but, you know, they’re, when they’re putting the right information in you should come up with the right answer, shouldn’t you, you know? So I mean I was, I was happy to go with that.
 
So your understanding is they put some information in about your personal case and it came up with the recommendation?
 
They put in all the - well, from what I, the way I take it, they must have put in all the symptoms and everything, all the tests they had done previous to that, you know. And they put it all on the computer and it come up with that. Because I’d done all the biopsies by then, you know, on the prostate. They had took a bit of the prostate away and, you know, and they cut it up, whatever they do with it, you know.
 
Well, I hate computers, you know. But I don’t know why I let, I don’t know why I let the computer make the decision. But I thought, I was putting, I put a lot of trust in the nurse who looked after us, and I knew she wouldn’t just go on the computer and say, “Oh, we’ve got a spare date for the, do a bit of surgery here. We’ll practise on Ronny” you know. But I knew, you know, I knew she would put every detail in that she had to and come back with a genuine - I knew by her face what she was going to say, you know, by the look, I thought, “Oh, yeah.” But I was happy to go along. I accepted her, I trusted her. I trusted her.
 
So there wasn’t a point when, when it came through with surgery that you thought, “Ooh, maybe I’ll drop out now”?
 
No, no. That never crossed my mind, you know. As I say, when they done my pre-ops, two weeks before I went, when they told, actually told us and they actually done all that, I think they thought, “Well, he mightn’t come back”, so they done them all, you know. But, no, I would, I’d made up my mind and I wouldn’t have.
 
Tell me a bit more about that and the thinking that you might not take part. What do you think?
 
Well, all the time I had been going I was a nervous wreck, you know. I was. I was very bad, like, you know, nervous. And they could tell. And we used to joke and God knows what about it, you know.
 
And, how can I say it? It’s, I was getting frightened and more frightened as it got nearer and nearer, because I knew, well, it’s going to have to be something or other, you know. 

FOOTNOTE: 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. This means that, going into a trial, everyone, regardless of which of the treatment groups the computer allocates them to, 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. 

People are allocated at random to one of the groups in the trial, often by using a computer programme. Their personal characteristics are not taken into account when they are allocated to one or the other treatment. Random allocation helps ensure we are comparing two very similar groups of patients, so if one group does better than another, it is very likely to be because the treatments being compared have different effects, and not because of differences between the people in the groups. That's why random allocation to the treatment comparison groups is so important. 
 
Some people’s preferences were so strong that they decided they could not take part at all, especially if they knew they could get the treatment they wanted outside the trial (see also ‘Deciding not to take part in a clinical trial’ 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. If, in spite of the treatment uncertainties that the trial has been designed to address, people would strongly prefer to have one of the treatments being compared, they should not volunteer for the trial.
 

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.
Of course trials are done because there is a possibility that a new treatment will be better than the standard or control treatment, and it may have already been shown to work for other conditions or groups of patients. However, the trial may find the new treatment is no better. Amanda felt more needed to be done to explain to people that trials are run where we genuinely do not know which treatment is best. This might help reassure people who have a preference and are worried about being randomly allocated to a group.
 

In a randomised trial we do not know which treatment is best, so we don’t know if it’s better to...

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Age at interview: 54
Sex: Female
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Well, it sounds terrible that, you know, you’re just going to be chosen by lot whether you’re going to get the treatment or not. Well, I think the, the key thing is to explain to people, “We don’t know which treatment’s better, so that whatever happens, we don’t know whether you’re going to be advantaged or disadvantaged by it.” I mean, there’s been a recent pro-biotic yoghurt trial in pancreatitis, and they had to actually stop it early because it appeared to be killing people. Now people probably wanted to get the pro-biotic yoghurt, but we didn’t know. And it’s, and it’s quite a shock to people that “Actually, hang on a sec, these things could do more harm than good.” There’s some idea that if something’s natural that it can’t be harmful, but it’s just not true.
 
So I think people have to understand about that we don’t know. People have got to understand just how often we’ve been misled, and we’ve done things that really looked good and actually have turned out to do masses of harm, and that our only way is that as a collaborative venture, to go in these things together. I – how do I explain? When I’m teaching the public about trials, I don’t teach them about randomisation I, I say to them, you know, “Here, let’s do, let’s do this experiment, you design it” and then they design it in one way, and I say “Can you think of why you might get a result which isn’t true due to the design, that is not an effect of the drug but for some other reason?” and they come up before, by the time we get to the end of the workshop, they’ve come up with randomisation as a method, they’ve come up with blinding, they’ve come up with all these things.
 
And because they’ve designed it themselves, because they see that unless you have two groups that are truly comparable, you can’t know whether if one group does better than the other group whether it was due to the intervention or due to some pre-existing difference. And then, you know, we play games with chocolate in envelopes and things and they note - to show that randomisation actually is strangely enough the best way of getting two groups that are comparable. It’s better than, it’s better than matching the groups. It’s strange but true. And if you play those games and then you realise that this is the best way to get two groups that are comparable, and if they’re not comparable, the whole trial you can’t believe the results, then people have no problem with it.
 
I think, you know, how much can you do, consent people? I think there needs to be a more generalised educational process really.
In some ways, random allocation can help people by removing the need to make a difficult decision. As Ronny (above) argued, letting the computer allocate him “would take the decision away from me.” However, this was based partly on a belief that the computer was calculating the best treatment for him based on his personal medical details, which is not in fact the case.
 
Alex understood that the decision was random, and was happy with this as a way to make the decision when doctors were unsure what to recommend.
 

Alex understood doctors were unsure whether to recommend surgery for heel fracture or not. He had...

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Age at interview: 38
Sex: Male
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Well, as I said, I had a slight preference. I can’t even call it that - but I had an idea that maybe, well, it hurts enough that maybe [laughs], maybe an operation would be better than no operation. But this was just, this wasn’t any rational, rational thought. This was just a feeling. So no, I mean, I understand what randomisation means and I understood that, that it could go either way and I was prepared for that, and it went the way I was sort of feeling, but I realise there was a fifty-fifty chance that it would so, yeah.
 
What do you think you would have felt if you’d been randomised to the other group?
 
Oof.
 
Would you have stayed in the trial?
 
I think so, yes, yes.
 
I didn’t see any reason why I shouldn’t do it, right? And there maybe there may well be other cases. There may well be other cases where people feel they don’t want to do it or they shouldn’t do it for all kinds of reasons. I can’t even list in my mind all the possible reasons. Maybe they just, maybe it would take much more time than it took in my case. Maybe it would be against their wishes in some sense. Maybe it would be against their religion, I don’t know, or against their convictions. So it’s everybody’s decision. It’s obviously up to them.
 
In my case it was an easy decision. There were two ways of treating my condition. I was explained that the doctors are not clear themselves about which treatment is better, in general, let alone which treatment is better for myself. So another way to put it, they probably would have to do something like random choice anyway, even if it’s not random choice, but they would have to decide somehow among two very close possibilities, among two very equally weighted possibilities. So it wasn’t going to make it any worse for me. It was probably going to do the tiny bit I did to help the doctor understand, the doctors understand this condition better, so I gladly and easily agreed to that.
 
So everybody’s situation is different. While I hope, I hope people don’t get into serious troubles, and if they do then they consider taking part in medical trials if they can. 
Gill also commented:
“If you’re randomised into a trial where there are three different methods, or surgical techniques… as long as you’ve got a reasonable outcome you can live with you don’t mind... But you’d have to have that feeling that you didn’t quite know which one you wanted to choose.”
 
Lester agreed that people need to feel confident that the trial really is on a topic where we do not know the best treatment. But that in turn depends on whether patients trust their doctor. (See also ‘Deciding not to take part’).
 

It comes down to whether you can trust your doctor if they tell you they do not know which...

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Age at interview: 59
Sex: Male
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Yeah. A couple of my chums have had cancer. And it’s interesting listening to them talk, because there’s often the case of, they will say, “I’m with one of the best cancer specialists in the country.” And they have to believe that, and they probably are. And they, there is certainly almost a badge of honour in trying out new therapies. And again I... sort of when you’re within a trial you have got lots of people around you, and I know there’s this real thing about the support, that, you know, you’re welcomed in. And rightly so. So maybe randomisation, if you think you’re being dealt with by somebody who’s really good and they truly honestly don’t know whether x or non-x is better, and they say, “Look, we truly don’t know. Would you be prepared to be randomised?” I’d probably say, “Yes.” So actually thinking about it, and thinking it through in my own mind, it absolutely and utterly comes back to the trust of the person you speak to. So therefore thinking about that, we know that there’s great, there can be great trust in the structure of a trial because of the influence of the ethics groups. It’s about having the sort of clinicians, having the absolute trust, both individually and also as a group of people, never to lose that. Because once you’ve lost that, you’ve, you’re on a sticky wicket really.
Although no one can be entered into a trial without their consent, some people we talked to trusted their doctor to tell them all they needed to know and were not very interested in the details of the trial, whereas others wanted to gather much more information. There is considerable debate about how much information is ‘enough information’ to be sure consent is properly informed. (See also ‘Information and questions’). Elvan did not remember being randomised or that the trial he was in was comparing one group with another, but he was happy to trust his doctor that going into a trial was a good thing for him to do.
 

Elvan feels you need to trust your doctors as the experts. It didn’t matter to him which group he...

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Age at interview: 84
Sex: Male
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Well, you’ve got to trust them [doctors], you’ve got to trust them. Whether they are good or not, you’ve got to trust them. They are the ones who go to the medical school to, for the purpose of helping those who are sick and all that. So you’ve got to trust them.
 
As I said before all that I’m concerned is what they are doing, or what they can do to help me to bring back my blood pressure down to normality. That’s what I was concerned about. Whether it was one group or the other don’t matter to me. 
 
Very few people said they genuinely had no preference for one treatment rather than another. As Lester suggested, “Randomisation is difficult the more serious the issue is... If it’s something like about my survival or a big element of my quality of life, randomisation is a big ask.” Others agreed that randomisation was easier to consider in trials where someone was not seriously ill or the differences between treatments were small. However, Jayne was comfortable with the idea of randomisation even in the case of serious illness, perhaps partly because she was studying evidence-based medicine.
 

Jayne did not mind being in the control group, even though the new treatment tested in the trial...

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Age at interview: 47
Sex: Female
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I was given an information leaflet about the trial, about the drugs and the options, but the, once the consent forms were signed, it was, the randomisation allocation was done over the phone, from because it was a Cancer Research Campaign trial, so it was done through their headquarters, and then after that I got my tablets and started taking them.
 
I was allocated to the tamoxifen alone group, and like any trial there are advantages and disadvantages. The advantages of that was that it was just a tablet every day for two years, whereas the Zoladex [goserelin] one was an injection once a month for two years, or you could have them both together. So in a way I thought I’d got off lightly. But actually now that the results of the trial have been published, I think people in my situation now are routinely given the Zoladex, so I was probably not in the winning arm of the trial. But you don’t know that when you go into the trial and… there are side affects and risks of the Zoladex, which aren’t particularly pleasant, so everything’s a balance. So it didn’t worry me whether I was in the winning arm or not. It was the taking part that mattered.
 
Does it worry you now looking back?
 
No, I’m quite philosophical about it. So they, they didn’t know at the time. It was a new drug, can have nasty side effects, meant an injection every month whereas I, you know - no, I’m not bitter about it, no, not at all. 
More commonly, there were several people who had a mild preference for one group but did not really mind if they ended up in another group. It is worth remembering that the control group is usually the best current treatment, if one exists, and it is what you would receive if you did not enter the trial.
 

Sue would not have minded if she had been allocated to the control group. Control groups are...

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Age at interview: 44
Sex: Female
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I sent the form in. They then contacted me and arranged for a lady to come round and see me, a person to come round and see me, to interview me and explain all of the different things, and that she would then tell me which group I was in. So she did it. That was all explained after I’d said I would do the trial. And so the lady came out to the house and just went through everything. So it was, it was so it was very clear, really, because she talked me all the way through it. And then she showed me what the different things that they would be doing, and the different things about, you know, how the trial would be run and, you know, she just went over, she did get, she went over the things that had been written down, but just so it was clear, and you understood what they were doing, why they were doing it and how they were doing it.
 
If, when the allocation was done, you’d been allocated to the group that just got the usual care, would you have felt differently about whether or not to take part?
 
…I don’t – no, I don’t think so. I think, I suppose I strongly believe that, you know, unless you research things you’re never going to learn anything more anyway. You can’t just suddenly pull [clicks fingers] “There it is”, out of the blue. You’ve got to research it and you’ve got to have, in a trial, you’ve got to have a normal or - I don’t know whatever would be the right name - you’d have to have a thing to be able to measure it against, so.
 
Mm. A control.
 
Yeah. Control, that’s it. Yes. So you’d need that. So no, I wouldn’t have. No, I don’t think it would have affected it at all. You know, I wanted to get in part of it, so. 
 

Consenting to the trial was not a huge decision. Both groups had chemotherapy, one every two...

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Age at interview: 45
Sex: Female
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I think my appointment was probably about ten days after diagnosis. And it was at that time my husband and I went up to the oncology and they brought it up then and he just did a diagram for us and told us what was involved. And there again, I thought, “Oh, two weeks, that sounds good.” [laughs] But this actually finishes at the beginning of September.
 
Were you happy with the amount of information and how easy to understand it was
 
Yeah. It was, you know, like I say I didn’t have to decide whether to have one particular treatment compared to another. It was just a timing thing, and it seemed, you know, it didn’t seem like a huge thing. I’m having the same treatment, and I’m responding well to it and I think that’s - so I didn’t feel that I had, you know, had to come home and mull it over or think about it or anything like that.
 
So did you decide on the day?
 
Yeah, yeah.
 
Sorry.
 
Well, I told them I wanted the two week one but he said, “Well, it just goes into a hat so we have no control over that at all.” And then the research nurse phoned in the afternoon and said, “Unfortunately, it’s three weeks.” I said, “Oh okay, never mind.” And I was really quite upset about it, because I really thought, you know, my stepdaughter’s getting married in August and I thought, “Well, it would just be nice to get it all done.” But a lot of people have since said, you know, I know a lot of people in the NHS and they’ve said, “Actually, it can be quite gruelling.” But I’ve responded so well I don’t think it would have been for me, but anyway, it doesn’t matter, and I am on the three-week one and I’m completely reconciled with that now. So it’s not a problem.
 
And when you were thinking about whether or not to take part, what were the main factors that made you want to take part?
 
Well, research, I just think it’s so important, and they’ve already done the trial in Germany and it’s showing that the every two weeks is, is perhaps better.
 

Merilyn was quite pleased when she found out which type of by-pass surgery she had been allocated...

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Age at interview: 57
Sex: Female
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I actually went and had the bypass in November 2004. When I went into the ward, I was approached by one of the consultant’s nurses, who asked me if I’d be prepared to do a clinical trial. I didn’t really understand anything about it. It was called ART, Arterial Revascularisation Trial. And usually in a layman’s term what it meant was, the usual way of doing a bypass, they take veins from the leg or the arms and do the bypass with that. The actual ART trial meant that they didn’t do this. They actually took the arteries from your chest wall. And what it, what they explained to me was it would be done randomly. You might have it done that way or you might not, you wouldn’t know until you woke up. So it wasn’t until I woke up that I realised that I’d actually had the one, the arterial revascularisation. And it, when I had it all explained to me it sounded quite logical. It seemed that obviously an artery is bigger than a vein, and hopefully I might never need another bypass or I might, it might take me a long time to have another bypass. I’m crossing fingers [laughs]. I feel pretty good [laughs]. And as I said I’ve had this four years now. I’ve had no problems, no angina, I’ve had no time off of work and I feel great.
 
And when she explained to you that you would be put at random into either the group getting the vein from the leg or the trial--
 
Yeah.
 
--group, were you worried about that?
 
No, not at all. I just hoped I had the one from the chest, so I didn’t have another scar, because I knew I was going to have a big scar, but obviously the less scarring you’ve got the better, so I was pretty glad when I woke up to find out I’d had it done that way.
 
What do you think you’d have felt if you’d woken up and found it was the other way?
 
It wouldn’t have bothered me, no. I had to have it done. Obviously there was a problem, and I wanted to get the problem sorted out, so, no.
A few people wondered why we could not have trials where people are allowed to choose which treatment they want and then the outcomes are compared.
 

Polly wonders if we could run trials where people could choose a treatment rather than being...

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Age at interview: 61
Sex: Female
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And I had a feeling about this trial and possibly about other ones that I’ve read about that there isn’t a very strong reason why people shouldn’t have cho-, been allowed to choose which treatment they had and then be followed through the trial according to which they’d chosen. I can understand that in some treatments you would get people with certain levels of illness or disease who would choose one treatment rather than the other, which would then distort the results. But if you could have people all, say, at exactly the same level or condition of breast cancer as far as it was measurable who were then free to choose which they had and followed them through, it might have slightly distorted, made it a slightly less perfect trial, but I suspect it wouldn’t have had a very big impact, whereas it would probably have attracted many more people to go onto the trial if they felt in control of what they decided to do.
 
Have you debated that view with doctor friends or scientists that you know? And have they persuaded you otherwise?
 
I have talked to doctors about this, about whether or not people could actually choose which treatment they were going to opt for when they went into a clinical trial. And of course it depends very much what the trial is. I mean, there are some things that are really quite straightforward, where everybody on the trial has more or less the same condition in more or less the same stage, and it isn’t going to make a huge difference whether they have actually chosen to go onto one treatment rather than the other. Other, in other conditions you can see that if somebody, if you had a very wide range, where some people were at a very acute stage, perhaps near to death, and would take anything, and other ones at a very early stage, it would distort the results of the trial because the people the most desperate would be more likely to be the ones that would take the treatment. But they might of course be the ones who had the least good results at the end.
 
So I think it would vary depending on what the trial was. But it seems to me that it should be an option considered when doing a random - when doing a, a clinical trial, whether it might be possible to let the patient choose. But I can see it would vary very much depending on what the case was.
 
FOOTNOTE: There are trials called ‘patient preference trials’, in which patients with treatment preferences are allowed their desired treatment, and those without strong views are randomised as usual. However, in analysing such trials it is not clear how to allow for the fact that patients who choose a treatment may not be comparable with other groups. An article from the British Medical Journal explains more about what a patient preference trial is and its limitations.
  
There are trials called ‘patient preference trials’, in which patients with treatment preferences are allowed their desired treatment, and those without strong views are randomised as usual. However, in analysing such trials it is not clear how to allow for the fact that patients who choose a treatment may not be comparable with other groups.
 

Jayne explains the need for randomisation to have comparable groups of people in each arm of the...

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Age at interview: 47
Sex: Female
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How would you describe the reasons for randomisation?
 
We’ve got to be sure that the patients getting Treatment A aren’t in any way different from Treatment B. Now, every clinician or patient has got their own in-built prejudices or biases, whether they’re aware of them or not, so to overcome those you have to rely on either a list of random numbers on a table or a computer-generated one where they haven’t got any feelings or instinct. They just spit out a load of numbers, and all the odd numbers get Treatment A and the even numbers get Treatment B. So it’s a way of ensuring that the people within each group are as similar to each other as possible, that there are no systematic biases or in-built differences, that they’re not all older or fatter or more educated or, you know, all blonde people or, you know, anything like that. They’re not systematically different.
 
And sometimes you hear people puzzling about why it wouldn’t work just as well to let people choose which treatment they had and provided there were large enough numbers and you collected enough information about different variables to control for when you analyse the results, why that wouldn’t work.
 
Because every individual has probably got in-built prejudices against one or other of the treatment options, and it may be that if you are of a certain type of person you would choose Treatment B and a different type of person would choose Treatment A, and therefore you get different types of person having the different treatments, and it’s the differences between the people that make the difference in the outcome and not the treatments. And when you’re analysing the data you can’t account for every known factor between the two types of people. You’ve got the crude things like age, socioeconomic group, sex, ethnic origins and stuff, but there’re all sorts of other subtle things that you might not record or have a valid way of recording it. But with randomisation they will be randomly split between the two groups.  
Some people wondered about ways in which trials might be affected by the types of people who are recruited. Danny, for example, discovered that trial appointments might clash with summer holidays and that she might be excluded as a result. She commented, “Now, it raised the question with me… are they just trials for people that can go up there at the drop of a hat, or are retired and sick, or unemployed?” Gill wondered whether the way people were approached or the kind of information given out might make some people more likely than others to join a trial. However, in a randomised trial this will not affect the result, because the different types of people will be distributed equally between the groups.
 
Amanda and Rosamund reflected on the importance of well-designed trials with high numbers of participants. (The number needed in each trial – the ‘sample size’ - to get reliable results will depend on the condition, the treatment being tested and how big or small an effect the treatment is expected to have. See also ‘Different types of trial’).
 

She wonders if the nurse didn’t want her doing anything extra that might affect the diabetes...

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Age at interview: 54
Sex: Female
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I was certainly eligible and at that point I was intending to go into the trial, and just their inability to give me the most basic information - okay, maybe a research nurse is not, you know, the people running the trial might have known it and they - but you’d have thought you would have trained up the personnel at the frontline in that particular disease having, you know, I wouldn’t expect every nurse to know the kind of information I was asking, but I would have expected a research nurse on that particular trial to know it.
 
Was your worry more about what that meant for the trial and whether they’d actually done enough literature searching to make sure that this was a sensible intervention to choose? Or was it more about yourself and thinking “Heck, I’ve got high blood sugar. I want to know that I’m getting a sensible intervention”?
 
It was definitely about myself. It wasn’t thinking, “Well, if they don’t know this then they’re doing the whole trial badly.” It wasn’t that thought. It was very much about my personal relationship with them, and thinking “I, you know, I need this information. Why aren’t they giving me it?” And also, I don’t know whether it was true, but I wondered whether they didn’t want me to know, to know about it, because they didn’t want me, anybody doing anything that might affect the result of the trial. And I thought, “That’s totally unethical.” And besides which, randomisation means there’s just as many irritating people like me that are going to go and do, you know, additional interventions in both arms so it doesn’t matter, you know. That’s the whole great thing about randomisation. You get two groups that are comparable, and yes, people go and do extra things but they do it in both arms so, so what? So I did get that kind of feeling about it, which I think, you know, given that there is something that you can do to prevent onset of diabetes, you know, get your weight down, do exercise, then if that was being withheld from me, rather than pure ignorance on behalf of the research nurse, then that’s totally inappropriate.
 
I did wonder if that was partly the motivation, that they didn’t want any confounding variables creeping in, and people…….
 
Yeah, but you see they’re not really confounding variables; it’s just noise that means you need a bigger sample. Just like people filling in the wrong diary on the yoghurt trial - there’s bound to be odd, you know, “I can’t remember”, and misclassification of the stool [laughs], you know, softer or harder than it was, you know? There’s bound to be that. The point is you’ve got enough people for the true result to be coming out despite that.
 
FOOTNOTE' The number needed for each trial (the ‘sample size’) is proposed by statisticians doing ‘power calculations’. In some cases a small number of participants may be enough, but if you are looking for fairly small changes in outcome you will need large numbers of participants to pick these up reliably.
 

Rosamund would not have agreed to take part in a study which did not use randomisation to make...

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Age at interview: 64
Sex: Female
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I think the attitude to being asked to take part in a trial should always be, “Yes, I ought to do it provided that the trial is well-designed and is going to answer an important question.” I think far too much research - and we haven’t touched upon this but it is a point I would like to make - far too much research is done in such a way that the question can’t be answered. And the advantage of a trial with randomisation is that you do have, you should have, comparable groups. So that in this trial the kinds of women who are in the control group are going to be the same kinds of women as are in the screening groups.
 
And therefore the answer to the question is likely to be much more reliable. And if randomisation were not used, if there had been some other method of allocating women to these groups, I would not have taken part. So if it had been some kind of matching in terms of history or, you know, social class or something, I would have said, “No, I’m not going to take part. If you do it as a randomised trial, yes, but not if you use some other kind of way of distributing people between groups.”
See also ‘What are clinical trials and why do we need them’.

Last reviewed September 2018.
Last updated July 2011

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