A doctor, nurse or other researcher should always seek your consent to enter you into a clinical trial. They cannot enter you into a trial if you do not give your consent. It is important that you have enough information to give informed consent, and an opportunity to ask as many questions as you like. The UK Clinical Research Collaboration booklet on ‘Understanding Clinical Trials’ (see Resources), has a checklist of questions you might like to ask. You can print off the pages which include space to jot down your own notes.
People have different preferences for how much information they want. To help you decide whether to take part, the researcher should explain:
• The aim of the study – which uncertainties it is addressing and what it is trying to find out
• How you will be treated and what you will need to do
• What the possible risks and benefits are
You will also be given an information leaflet or ‘patient information sheet’ which you can take away and read. If you decide to take part, you will be asked to sign a consent form to say you agree to take part. (If English is not your first language, the trial should be explained to you in your preferred language and you should be given a consent form in that language).
Many people we talked to felt they had been given very good, clear explanations and were able to make informed choices. Here, Sue explains how she was given both face-to-face and written information, an account of what the trial was testing, reassurance that she could withdraw at any point and a guarantee of confidentiality.
It was explained clearly to Sue that there was a trial comparing the effect of different types of...
It was explained clearly to Sue that there was a trial comparing the effect of different types of...
Age at interview: 44
Sex: Female
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She explained to me that it was a trial of people who’d already had one caesarean, and how that they, how they wished to proceed with the second birth, or the following birth. And she told me that there would be different, there would just be different questions, different facts, you would have, be given more information, and that - to help you make your decision. And that she said that I would be interviewed by people, and she told me that if I wanted to pull out at any time I could. If I, you know, wanted it to stop, I could.
And obviously everything would be treated confidentially. And then she asked me to, as I wanting to go forward with it, you know, to take this piece of paper away, read all about it and then sign it, and, you know, send it back in, which I did. I mean, well, I actually just signed it there. I mean, I read through it there, and then signed it, so again, so...
And so did, did she say what the different groups were going to be in the trial, and how you’d be allocated to one group or another?
I can’t remember if she said it then, or whether it was… later, I really can’t remember. I was told - actually it was on the information sheet that I was given, that there would be three different groups. One - and I can’t remember the exact things - but one would be, you know, different decisions and different, there would be three different segments of how the trial would be run, and you would be allocated into one of the groups, and that was actually written down in the thing.
Sue could not remember much detail about the specific interventions, some months after the trial. This may be partly because, for many people, the trial does not feature as strongly in their memories as their illness or condition, even if at the time they had all the right information. As Angela said, “I felt informed. I may have forgotten since.”
In some cases, it may also be partly because it can be difficult to take it all in at the time. Wendy mentioned that she was given a tape recording of the consultation with the professor in which they discussed the trial so she could listen to it again at home. She thought this was a good idea. Others said it helped to have another family member or friend there with them to help remember what was said. In one trial, people were given a useful DVD to watch as well as written leaflets. Seeing as well as reading made it easier to grasp.
Having a DVD as well as written information was really helpful. Alex did not feel much need to...
Having a DVD as well as written information was really helpful. Alex did not feel much need to...
Age at interview: 38
Sex: Male
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Do you remember what information you were given, what kind of things you were given to help you make up your mind?
Oh, that was actually quite helpful, because I was given a - I was already in hospital, in a hospital bed - and I was given a portable DVD player with a record of, of the head of the team, a professor, from the university who are running this trial. And, and there was quite a detailed explanation of what the structure is and how it’s treated, and what the options are so I think this was one of the most useful things that, that I actually received as information, yes. And there were leaflets and there were forms, but actually, somehow this, it helped to see this DVD, yes, definitely.
And did you talk to anyone else to help you make up your mind? Did you talk to your family, your wife?
To make up my mind about taking part in the trial? Well, my wife was around at the time. I mean there was no question. Why wouldn’t I take part in the trial? So I don’t I don’t remember if I actually discussed that, or it was obvious to both of us, but it was I think obvious, yeah. Why not?
As far as Alex was concerned, the trial was not something he felt needed much discussion with other people. However, others valued having time to discuss it with family, friends (including friends working in healthcare) or another health professional. (See also ‘Being asked about taking part in a trial’).
Polly advises people to ask a lot of questions and get a second opinion if possible.
Polly advises people to ask a lot of questions and get a second opinion if possible.
Age at interview: 61
Sex: Female
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I think anyone being asked to take part in a trial should ask some quite penetrating questions. I mean, I think first of all they should approach it in a positive state of mind that on the whole we patients would like to help science wherever at all possible. Doctors are trying to provide better proof, better evidence, better treatments, and I think it’s the least the patient can do is to help as much as they possibly can. But in the end you have to look at the particular trial very, very carefully. And I think really you need, it’s a good idea to get a second opinion from somewhere else, if it’s on something that’s very important. I mean, if it’s something minor, obviously not. But if it’s something, you know, possibly life-threatening that you suffer from, then I think you really need to know all there is to know about the treatments that you’re being offered, or possibly denied, if you’re going to be randomly put into a group that’s going to get a, what might be a very good treatment or into a treatment that perhaps might do you some damage. You need to know what those risks are and decide whether you’ll take them or not. Of course some trials, you’re not going to be offered the treatment unless you’re on the trial. I think that’s a very, very difficult call and I think that puts a lot of pressure on, on patients who perhaps very much want the treatment, can’t get it any other way, but might be randomly assigned to a group that don’t get it.
And I think that’s a deep ethical dilemma. Of course if it is a very, very new treatment and the scientists genuinely don’t know if it’s going to work or not, I don’t see how else they can proceed except on that basis. So I wouldn’t rule it out and say, “That’s unethical, that’s unfair”, because I can’t quite see any other way of, of resolving it. You can’t give everybody every drug that might have some effect indefinitely. It could be dangerous as well as expensive.
As Julian and Tom pointed out, each person will want different levels of information and it is very hard for professionals to get this right each time. It is also difficult for patients to know what to ask.
It's very hard for doctors to judge the right level of information to give each person, and for...
It's very hard for doctors to judge the right level of information to give each person, and for...
Age at interview: 61
Sex: Male
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It’s very difficult, obviously, for the doctor or whoever it may be that’s talking to you to gauge what level of understanding you already have, so they don’t want to talk baby talk to you, but equally they don’t want to talk above your head. I don’t mind particularly if people talk baby talk to me because I can indicate that I want to know a bit more in detail. I do get irritated with people who talk baby talk and seem unable to go beyond that. So then I take a very dim view. I think, “This guy or this woman doesn’t really understand what they’re doing. They’re just like the repair man that comes to tighten up the screws on the fridge without really understanding what’s going on inside.” And so I feel dissatisfied if the doctor I talk to doesn’t understand, or doesn’t show that they understand what’s going on.
Have there been some instances where you’ve felt they didn’t really understand the trial or the, the mechanisms involved?
Yes, not I should say at the research-oriented hospital that I’ve been to, though even there, there were one or two cases where people I thought seemed a bit dim [laughs]. But anyway, that’s inevitable and one shouldn’t complain too much. People talking above your head I don’t mind, because I’ve got in the habit when I don’t understand something of saying that I don’t understand. It’s quite a difficult habit to cultivate, especially if you’re supposed to understand and know about things. But I would urge patients always to stop and say, “Stop”, and, “Explain that to me. I don’t know what this is or that is.”
So where have you been more conscious of this people not really understanding? Is that at the GP’s surgery or?
My GP has been fine. He doesn’t lay claim to knowing all the ins and outs of the molecular biology. He says that’s not his concern. He refers me for that, but he’s very good on all the things that he undertakes to do. The specialist hospital has been fine, by and large. But the intermediate place where I was first diagnosed was more uneven, so there are some very good people and some not so good.
He knew he could stop if the side effects became too bad. He felt the staff explained it well,...
He knew he could stop if the side effects became too bad. He felt the staff explained it well,...
Age at interview: 63
Sex: Male
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We were all getting the drug, and there were, the explanations from what I can recall were very good. It was explained again about I can withdraw at any time, if they find I’m having bad effects with the drugs that they’re giving me or, then they would pull me out, because I think obviously they were looking at the quality of life, as well as trying to find out if this drug was effective, you know. I have no complaints about that side of it at all and the nurse, the research nurses who were involved also were very good at explaining, and they would take their time, either if myself, or Helen, or any of the other patients who were there had questions. Some patients didn’t have questions. As usual some people want to know everything and some people don’t want to know anything, some people want to know a wee bit, you know. But because my, I felt whatever was going to happen to me, whatever decisions I was going to take it was going to affect my whole family, so I wanted to know everything, which perhaps maybe made it a bit easier for the medical staff because they knew, “Well, Tom wants to know, so we can talk to him, we can tell him”, you know. But I have no - on recollection the medical staff at that time were very good with their explanations.
Joining a trial when you have a serious illness is very different to 'healthy volunteer' trials....
Joining a trial when you have a serious illness is very different to 'healthy volunteer' trials....
Age at interview: 63
Sex: Male
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I still speak to people who talk to me and they say, “What did you say? Clinical trial, what is that?” There is a lack of knowledge, a lack of education, perhaps, coming out about clinical trials. One of the things that did surprise me about the episode – what was it - a couple of years ago, at was it Northwhich?
Northwick Park*.
Northwick Park, there was bad publicity about clinical trials at that time, but I think what people have got to remember, and possibly what didn’t come out enough, was the fact that that was not a clinical trial that we are actually talking about today. That was a clinical trial where it was healthy people being paid to take part in a trial, in an experiment, say. That is a totally different thing from if you have an illness and you’ve got the best treatment, but you’ve got the option of taking part in what might be something new. It’s a whole different ball game, it’s a different kind of trial, I believe. I think one of the things that did come out of it I was told that all of a sudden there was many more volunteers to take part in clinical trials. That was a clinician said that, it’s not that long ago in fact that we were talking about it, and he said yeah, the enquiries they got about people taking part in clinical trials rose because of Northwick Park, so which surprised me. But that, like I said, that was a totally different kind of trial and I think there was bad publicity about that, but that’s not the kind of trial, I think, that we are seriously discussing here. But yeah, I don’t know how you, it’s a difficult one to get people - because it’s something that probably people don’t really want to know about anyway, until they’re in the situation. One of the things that clinicians have said to me, and I have briefly mentioned earlier, was the fact of patients asking them questions, and the sort of inclination was that, “Well, patients should know what to ask”, and I said, “Well, with all due respect”, I said, “Patients don’t sit, people don’t sit at home and say, ‘Well, maybe in the future I’ll get heart disease or a cancer, I’d better read up on it now and find out what I’ve got to ask’.” I said, “Come on, join the real world. People don’t do that. It’s when they’re diagnosed, that’s when they go, or if someone close to them gets diagnosed with a serious illness, that’s when they go and try and find out about different things, but they’ve got to be able to get the information.” And I said, “You can help give them that information.”
*FOOTNOTE' Tom 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.
A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
Everyone in a particular trial will be given the same patient information sheet, which will have been approved by a Research Ethics Committee, and which has to contain certain standard information. Some people found the information sheet just right, but some thought it was too complicated, while others thought it was not detailed enough.
Sabiha thinks long information leaflets can be off-putting. It would be good for people to have a...
Sabiha thinks long information leaflets can be off-putting. It would be good for people to have a...
Age at interview: 53
Sex: Female
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There was quite a lot to read, and I think sometimes that can be off-putting because, you know, sometimes you haven’t got the time to go through all the pages. And you put it away and you think you’ll read it, you’ll read it, to the point when sometimes it becomes quite urgent, when you’re about to go or take part. So it would be nice to have it in a like condensed way, with like the summary, which I think would be better, instead of pages and pages of information which sometimes people don’t have the time to go through.
Sometimes a lot of writing and a lot of paperwork can be off-putting. If it was to the point, summarised, condensed, and pinpointed the exact points that are more important would be beneficial and it wouldn’t put people off taking part in these researches.
The information leaflet was complicated and reading it made Marie angry. She was worried about...
The information leaflet was complicated and reading it made Marie angry. She was worried about...
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.
Rosamund got a letter about the ovarian screening trial.
Rosamund got a letter about the ovarian screening trial.
Age at interview: 64
Sex: Female
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Well, I had a letter through the post inviting me to take part in this trial, which is a very large trial over a ten- year period, designed to answer questions about the effectiveness of screening for ovarian cancer. There was a leaflet attached to the letter which I read, and I thought about it and I discussed it with some friends and colleagues, and I decided that the information in the leaflet really wasn’t sufficient for me to make a decision. So I replied saying that I, in principle, was happy to take part, but I’d like them, the trial organisers, to send me a copy of the full protocol. And there was then a six-week silence, and then I received the full MRC [Medical Research Council] protocol which did indeed, you know, answer some of my questions. And I felt some of the way the information was presented in the protocol and in the leaflet that went out with the initial letter was rather different. But I decided that I would take part. I also decided that I would like to be in the control group [laughs].
And then followed a slightly stressful period, in which I was sent appointments to be recruited and they were all during the working day. And I explained that I was in full time work and I needed an appointment either early in the morning or at the end of the day, and this proved impossible, which I think is a bit of a mistake, as many women - this trial is aimed at women aged between fifty and seventy-four - and many fifty to sixty-year-olds these days are in full time work. So after a bit of argy-bargy I went along at four o’clock in the afternoon to the local regional centre, and was told that I had to watch a video. And I said, “I’m sorry. I don’t have the time to watch a video and I have read the protocol and I think I know what this is about.”
Anyway, we completed the formalities, and then I suppose there was an interval of a few weeks and then I received a letter saying that I had been randomised to the control group, which made me happy.
Marie was put off the trial because she felt some key facts might be being withheld from her, or at least not made obvious. Like Marie, Rosamund felt some key things were missing from the information leaflet that should have been included. These included the fact that there might be some discomfort involved in having one of the interventions (a vaginal ultrasound scan for ovarian cancer screening), and the possibility that screening tests might produce false positive or false negative results. (A false positive would mean an incorrect diagnosis of cancer, while a false negative would reassure a woman that she did not have cancer when in fact she did, but the test had not picked it up).
She felt some possible disadvantages of taking part were missing from the information leaflet....
She felt some possible disadvantages of taking part were missing from the information leaflet....
Age at interview: 64
Sex: Female
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There is a comparison between two different screening strategies. One of them is called multi-modal, and that involves blood group, blood tests and then, if the blood test shows a particular result on the protein called CA-125, the trial participant has transvaginal ultrasound. The second group is the ultrasound only. It seemed to me that this method of ultrasound screening was likely to involve some discomfort, and I didn’t feel that that was actually spelt out in the leaflet. Nor did I think that the leaflet was explicit enough about the anxiety that can often be created when people take part in these kinds of studies, because there is always the risk that you’ll get a false positive result or a false negative result. And what was interesting to me was when I read the full protocol it was clear that the second aim of the whole trial was to assess the morbidity associated with screening and that wasn’t, I don’t think, clear enough in the leaflet.
I think it is important to be as honest as possible, and that if there had been a little bit more honesty about some of the potential disadvantages of being involved in these screening strategies that are being evaluated, I don’t think that would have actually put people off. So, I mean that is obviously the concern, isn’t it? But again you can really answer those questions in good pilot studies, and I don’t know what kinds of pilot studies were done for this trial, whether the recruitment strategies were piloted, whether the information leaflet was piloted. But it is possible to answer those questions in advance of, you know, the full blown trial.
Leslie was also concerned that some important things were missing from the leaflet.
He felt the patient information leaflet did not say enough about possible side effects from the...
He felt the patient information leaflet did not say enough about possible side effects from the...
Age at interview: 75
Sex: Male
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I was approached by my GP and asked if I would go on a clinical trial. The drug was a commonly prescribed one, an NSAID known as Vioxx or rofecoxib, originally designed to reduce pain in sufferers of osteoarthritis. It was claimed that US experience suggested that Vioxx appeared to diminish the effects of prostate cancer. My own quite extensive research has found little to suggest that any large-scale trials had been carried out. I was not pressurised by my GP who told me that Vioxx was a harmless drug similar to ibuprofen. There seemed to be little in the patient information sheet to alarm me and none of the potential side effects seemed of concern to me. I trusted my GP and I trusted the drug company as the information sheet assured me that I would be closely monitored and, should I be injured whilst on the trial, I would be compensated by the drug company’s compensation scheme, which followed the Association of the British Pharmaceutical Industry’s (ABPI) compensation guidelines.
I took the first tablet in December 2003. I had signed a consent form but, on reflection, my consent could not be seen as ‘informed consent’. I knew nothing of ‘good clinical practice’, of ethics committees, of the ABPI, the MHRA (Medicines and Healthcare Products Regulatory Agency), the NPSA (National Patient Safety Agency) et al. I was told nothing of the history of the drug or of other trials involving Vioxx. The patient information sheet said that heart attacks had been recorded amongst Vioxx users but it was not known whether these had been caused by Vioxx.
Footnote' Rofecoxib was withdrawn from the market in September 2004 because of concerns about the increased risk of heart attack and stroke. Leslie experienced severe gastrointestinal symptoms during the trial. The drug company disputes that these were caused by rofecoxib (Vioxx), though the judge who considered his compensation claim in court ruled that, on the balance of probability, rofecoxib was likely to have been a significant cause of his illness. The drug company originally announced it would appeal but eventually agreed £28,000 compensation in an out-of-court settlement.
Some people commented that they did not really read the information leaflet fully. As Judith said, “I’m still not one for reading through great booklets of it.” Not everyone wants or is able to read a long leaflet, especially if English is not their first language. Rose thought that, although she personally was happy to read things, more face-to-face discussion would help many people, but busy staff might not always have time to do this.
Jargon and abbreviations are hard to understand. Face-to-face discussion could help people who...
Jargon and abbreviations are hard to understand. Face-to-face discussion could help people who...
Age at interview: 68
Sex: Female
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And then I have difficulty with some of the literature they write, you know, and particularly being an older person now I’ve found in my latter years nursing that all of these new fangled things, you know, were quite - and I hated how everything was shortened. And so therefore, you would hear in the beginning of a, something which they would say ‘RT’ and then it would be repeated. They would give the full name, right, the full condition and then a little further on they would just give the capital letters and you’d be thinking, “Er?” You’d waste half of your time. So how people understand all of, all of the jargon that was thrown at them, even though I suppose that we think it’s simple [laughs]. It’s not very simple for lay people.
What do you think could be done better with the information? I mean, you talked about the fact that many people that you met didn’t really take it in.
Uh-huh.
How could that have been improved?
I think it’s simple, absolutely simple, and absolutely impossible with every thing with the National Health Service now. There is not enough staff. To me sometimes they’re throwing money in the wrong direction. There are so many chiefs, very few Indians. You know, and up in that clinic, it’s really is so busy and so few people are having to deal with it, it’s , so really the answer is there’s no answer. No answer to it. Because if you have too much staff then you’re falling over each other. There just isn’t an answer.
Are you suggesting they use written information too much because they haven’t got time to talk to people?
Yes, yeah.
Is that it? Okay.
Yeah.
So your preference would be for somebody, rather than giving you a leaflet and telling you to go away and read it, to --
As I say, with me I was quite happy to read them, but I know from what I see other people don’t read them. And I mean it really came up with just the, you know, all of the information that was given, maybe a couple of sheets of paper for when we went for the CHART [Continuous Hyperfractionated Accelerated Radiotherapy] that they hadn’t understood ‘bed and breakfast’*, hadn’t understood at all. But they told me what bed and breakfast was, but I retained it, you see. Nobody knows until they’ve experienced it before the confusion that really is in your head when you’re told. Like I said I started clearing a drawer out because the next day I was going to the [name] Hospital - instead of doing things where I would do it normally, you know, get my things out, pack a case, inform people who should be – no, no. I decided I had a drawer that was really messy and I really should, you know - crazy things. So I mean if my head had gone crazy, God help what other people’s heads were.
* The ‘Bed and breakfast’ system Rose mentions means an overnight stay for radiotherapy but not as a full in-patient. Patients are asked to bring their own medication with them, but some patients Rose met had not understood this.
Some people we talked to did not want to know much about the trial they were involved in. It was clear, for example, that a few were not really aware that the trial was comparing different treatments or that people were allocated at random to one group or another. (See also ‘Feelings about being allocated (randomised) to a treatment group’). Several people said that they preferred to trust their doctor to give them the explanations they needed, or that they had no option but to do so, given that they could never have the same level of medical knowledge. Some were happy with this situation, while others were troubled by the unequal relationship. There is considerable debate about how much information is ‘enough information’ to be sure consent can be properly informed.
Elvan feels you need to trust your doctors as the experts. It didn't matter to him which group he...
Elvan feels you need to trust your doctors as the experts. It didn't matter to him which group he...
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.
It's vital to understand all the trial information, but that's difficult for ordinary people....
It's vital to understand all the trial information, but that's difficult for ordinary people....
Age at interview: 69
Sex: Female
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I’m not saying that people shouldn’t go on trials but I think you’ve got to fully understand what they’re telling you, and for the general public that’s very difficult because we don’t understand medical terms. I was lucky because I had medical people behind me that could help me and I’m not stupid. And because it was just funny that the points that I made about this clinical trial were brought up by medical people as well, and they all seemed to have the same impression that you go into the trial, you go on, you give the approval and you do it.
But I think people have really got to understand the implications of doing it and I don’t think there is enough care given that they do understand, because we’re not medical.
What would you say to anyone else thinking whether to take part in a trial, not necessarily this one?
I’d tell them not to agree. Get all the information from them that you can. If you don’t understand it find somebody that can help you. It’s got to be somebody medically because without medical experience you can never understand it. It depends on your situation. As I say, if you’ve got six months to live and there is no hope for you and the trial is a chance, I think you have to take it. But if there’s hope with other things I think I would sooner put my faith in the drugs that are already available. But that is personal, this is me. I can’t read how other people feel but I do know that when anyone ever offered a drug and they’re seriously ill, their only hope that they’ve got, or what’s in their back of their mind is, that this trial is going to get me well. And that’s in everybody’s mind, not just me, that’s not personal. And I feel that you have to consider it at your own merits but you cannot go into that trial unless you have sat down with a friend or family who’s probably, or preferably, with medical experience, and he goes through with it with a fine tooth comb. And then you have to consider it. But I still think you’ve got to be very careful.
Lester suggested that having lay people involved in writing trial leaflets in the first place was a good way to make them more understandable. (See also ‘Public awareness and involvement’).
Lay people can help make trial information leaflets more responsive to patients. There are...
Lay people can help make trial information leaflets more responsive to patients. There are...
Age at interview: 59
Sex: Male
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Within the trial steering committee there are people from a broad range of disciplines and say several laypeople. And one of the things the laypeople would look at, and have quite a lot of control over, is things like, “Well, from, what would be acceptable to a person with no other agenda other than to get better or to learn? And how can you present that information?” So things like patient information leaflets, patient briefings, all of that would really have a big stamp of the layperson on it, so that they could look at it and say, “Yeah, this fits the bill.” Because again, you can imagine if you’re seeing somebody like a doctor or a surgeon who you hold in high esteem - because we do hold them as a profession in high esteem - it’s not a meeting of equals. They are in a position of power. I’m not saying they abuse it, but they are. They’ve got the knowledge or some of the knowledge, they’ve got the strength, they’ve got the reputation. There are you, or either as the individual or as a representative of an individual, sort of feeling vulnerable because you’ve got an illness, lonely because you’ve got the illness and here’s somebody who wants to talk to you about it, and also ignorant of a lot of what’s going on. So that meeting is a meeting of un-equals. And the trial steering group, I think, just try and make sure that all the information that a patient or a carer has is good enough to be able to get over that, that element really.
Several people who did try very hard to understand the leaflets found the amount of information rather overwhelming, and found the more questions they asked the more confusing it became. As Hazel commented, “The more I was finding out, the more I realised I couldn’t possibly give informed consent.”
Giving informed consent when she knew nothing about clinical trials, the condition itself, or the...
Giving informed consent when she knew nothing about clinical trials, the condition itself, or the...
Age at interview: 74
Sex: Female
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So it’s a huge problem of uncertainty what to do with this thing [DCIS, ductal carcinoma in situ, in the breast] that we’re now finding. So at the time I was only vaguely aware of this, but as I’ve learned more I suppose the, what has concerned me about seeking informed consent to enter a trial, particularly of, one of this nature, is the information that women need to have, the knowledge they need to have, and that this is almost irreconcilable and impossible, because how can your average woman on the street, like I was, be expected to know the ins and outs of randomised controlled trials, for a start off? If you don’t know what a trial is for, what its purpose is that’s a bad start. If you’ve just been told you got cancer, that’s a pretty bad start. If you don’t know much about the cancer you’ve got that’s not much help. So to have to give informed consent and agree to participate in a trial is a pretty tall order. That’s where I came in.
A key problem is that 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. So researchers need to explain this uncertainty to people. But uncertainty can feel very uncomfortable for patients and make it hard for them to feel they have enough firm information to make a decision. Joanna described a debate with a doctor over her husband’s leukaemia trial. Carers may have their own rather different information needs. “I got very uppity about, ‘What is informed consent? If you can’t give the information I need, how can one make informed consent?’”
At a time when people are already feeling vulnerable following a diagnosis or a hospital admission, dealing with information about uncertainty and difficult choices can seem too much. (See also ‘Being asked about taking part in a trial’). Sometimes people may want to choose not to have a lot of information and to trust their doctor to advise them. Polly (below) comments that ‘choice and trust are in different boxes’.
When people are sick they may not want choice. They may want their doctor to be honest about...
When people are sick they may not want choice. They may want their doctor to be honest about...
Age at interview: 61
Sex: Female
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I think choice in medicine is a very difficult thing, and I think patients are often themselves uneasy about it. And you do go to your doctor because your doctor’s the expert and say, “What do you think, doctor? What should I have?” And you can ask for lots of explanations. But in the end if you trust your doctor the odds are very strongly from all the evidence that most people will do whatever their doctor suggests, probably sensibly. If you don’t trust your doctor, then go to another one and then you’ll do what the other doctor suggests [laughs]. A lot of people will come to doctors with great piles of documents they’ve printed off the Internet, some of it from rubbish sites, a lot of dangerous stuff out there on the Internet. And, you know, the doctor then will spend a long time going through them and saying why they think they’re right or not right. But in the end it is down to trust. So choice is quite difficult. And I think, you know, the same is true about choice of which hospital to go to or which consultant to be sent to. In the end you probably trust your doctor to say, “Well, Mr so-and-so at X hospital has, you know, always seems to have done very well to my patients.” And I think lots of patients, and particularly the sicker they are, don’t really want choice. They want trust. And choice and trust are in different boxes. And very often if you’re left on your own to make really life-and-death decisions it can be very upsetting. You want to be reassured by someone who seems to know.
I guess there’s another conundrum, really, isn’t there? Because in trying to present a trial as a case of genuine uncertainty, there’s a risk that the doctor may undermine your trust by sharing that uncertainty with you.
I think that’s true. I think if a doctor says, “Well, I really don’t know. You’ll have to choose”, it can be very unnerving, because you really do want him to know. Or at least you want him to, you say, “Well, all right. I understand you don’t know.” Perhaps you want him to be honest about uncertainty. I think you don’t want him to pretend that he, to pretend he’s God. You want him to say, “Well, actually not enough is known about this condition” or, “Here are the options.” But in the end you want to say to the doctor, “But of what you know, what do you think the odds are? Which way would you really go?” And in the end you want the doctor to plump one way or the other, as best they can. I mean that’s, that’s their job.
Some people did not remember being given any information about uncertainty and some people, particularly in drug trials, felt it was being suggested that the drug being tested would bring them extra benefit. 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. Patients who desperately want to get better may interpret doctors’ words in a way doctors do not mean, or “read between the lines”, as Wendy said. This underlines the importance of staff being very careful about what they say and how. (See also ‘Being asked about taking part in a trial’, ‘Feelings about being allocated (randomised) to a treatment group’ and ‘Messages to professionals’).
Many people pointed out how difficult it is to absorb information or remember accurately what they were told, however hard staff may try to help them understand. Again, having someone else there with you can help. Caroline commented that in pregnancy, “Your brains do turn to mush a little bit….I would have found it quite difficult to concentrate probably.” At first Judith was just keen to get treatment started for her lymphoma, but now questions have started to occur to her.
At first she didn't know what questions to ask and sat there 'like a nodding dog'. Now she feels...
At first she didn't know what questions to ask and sat there 'like a nodding dog'. Now she feels...
Age at interview: 45
Sex: Female
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He said that, he said exactly that - that they didn’t know and they were looking and the research was purely to see whether the two weeks was better than the every three weeks. I think he might have said actually indications are showing that the two weeks is better, but again because I didn’t know, you don’t know what questions to ask initially, and I’m just sitting there like a nodding dog nodding at everything he says, saying, “Yeah, yeah, clinical trial, that’s fine. I’ll sign it.” And I guess that’s why they say you can go away and think about it. But I don’t, I just, there’s questions that I want to ask now that I’m further into it and perhaps feel a bit more confident. Because when you’re first diagnosed, you just want it gone and just say, “Just start. Whatever you need to do, just do it now and get it gone.” But now, I wouldn’t say I was completely casual about it, but I’m bit more relaxed and a bit more confident and want to ask, ask some questions about it to see what they mean about lifespan, or whether it’s relapse, or what, what it is.
Would you feel able to talk to them in between appointments? Is there someone you can talk to?
There is. There’s a Macmillan nurse there who I’ve got her direct line and I can just leave a message and she’ll call me back, and that’s no problem at all.
But I don’t feel I’ve got anything urgent enough to phone in between appointments, but I know she’s there. And I mean I have phoned if there has been something. I had an infection and that was very quick, and you phone the on-call haematologist and they just have you straight in to deal with it. But apart from infection, it can wait. It’s really not a problem. And she’s always about and she’s happy to talk.
The process of informed consent should continue throughout the trial. The researchers should continue to give you information and answer your questions. They should let you know if any new relevant information about treatments comes up during the trial so that you can re-think your decision, and withdraw if you want to.
Last reviewed September 2018.
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