Clinical Trials
Being asked about taking part in a trial
How people are asked to take part will depend on the type of trial. At one end of the spectrum, people may themselves actively look for trials to join, or answer adverts in newspapers, newsletters or notice boards. Often people will be contacted through their GP. The GP may speak to patients personally or send a letter on behalf of the trial, or the trial may get the GP’s permission to contact suitable patients directly. In some cases, trials are based in GP surgeries.
Jenny was pleased to be invited by her GP to take part in a trial of different treatments for...
Jenny was pleased to be invited by her GP to take part in a trial of different treatments for...
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My GP asked me to be in a trial because I was having major bleeding, absolutely awful, it was about every two weeks. I was bleeding so heavily and I was going through so much, so much sanitary protection it was unbelievable, and he just suggested that I went in for the trial, because he wanted to put me on mefenamic - or no, he wanted to give me options as to what I was going to have, you know. Either it was, I think it was three items. It was either the coil, another drug, and mefenamic acid, and I obviously got selected for the mefenamic acid. But that’s why I went in for the trial, because I was just in such, such pain with the, with the periods.
I was given a leaflet with the ECLIPSE* logo on the front and all the data about why they were doing the trial and what products were included in the trial, and everything about the trial. You know, it was all sort of randomised, and it wouldn’t, nothing would be, nothing would be associated with me personally. It would all be sort of like patient A, B or C, you know. I wouldn’t be defined as in my name or anything like that. And - but to be honest I would have been quite happy to do anything, because I was that desperate. You know, I would have been quite happy to just put my name to anything.
* ECLIPSE = Effectiveness and Cost effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for MEnorrhagia
FOOTNOTE' It is important to remember that you can have treatment anyway outside the trial and do not have to consent to a trial in order to be treated. Sometimes a new treatment will only be available as part of the trial, but in most cases there will be other treatments available.
Harry got a letter from the trial clinic saying his name had been put forward by his doctor. It...
Harry got a letter from the trial clinic saying his name had been put forward by his doctor. It...
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Well, I received a letter from somebody called ASCOT* and it was self-explanatory. They explained what their function was and they said that my name had been put forward by my doctor. Anyway it wasn’t, if you didn’t want, you didn’t have to if you didn’t want, but anyway I read about it. Now round about that time, I think I was 72, about, and I thought it would be a good time if I would have a medical procedure which would find out whether I had any age-related conditions which you would get but you wouldn’t know about it until it hit you hard, you see. So I thought that would be a good idea. So I put my name down, and I went up there, so I went up there.
*FOOTNOTE' ASCOT = Anglo-Scandinavian Cardiac Outcomes Trial.
Rosamund got a letter about the ovarian screening trial.
Rosamund got a letter about the ovarian screening trial.
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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.
Several other people we talked to had been approached in hospital, perhaps at a time when they were feeling vulnerable and worried, for example after a serious diagnosis or an urgent admission. The approach might come from their consultants, or from other staff involved in their care such as midwives or nurses, or from research doctors or research nurses.
Sue was asked about the trial when the midwife could not hear her baby's heart and she came for...
Sue was asked about the trial when the midwife could not hear her baby's heart and she came for...
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She scanned me and then, then said, “This is the trial and this is what we want to do. And this is what we want to look for and to see whether it helps.” And, you know, whether - because I’d had a caesarean before, you know, it was - yeah, she explained what the trial was about and what they wanted to achieve.
Did it worry you that you were asked at that point when you were, had just had this quite traumatic experience?
No, because it was – right, when I got to the hospital a lady came out and, you know, they were expecting me and she came out and she said, “Oh would you be prepared to take forward in this trial?” But then she took me in to see the person who does the scan and then it was then discussed afterwards. So no it wasn’t, because the scan was obviously positive, and it was there and so you could see everything. So my mind was totally at rest anyway, because I suppose obviously I’d gone to the hospital because my midwife couldn’t hear, but because I’d had miscarriages in the past, I was pretty, pretty certain that I wasn’t, I had not miscarried, because you know. You do know when you’re pregnant, or I always knew that I was about to miscarry. So I wasn’t that stressed when I went down there.
Okay.
I was in quite a, you know, sensible frame of mind. And in fact, well, I got an extra scan and saw the baby again and it was all really healthy so. So, you know, in a way it was good because I got an extra scan, and I got involved on this thing, this trial.
But they did actually mention it before you went in for the scan, the trial? Although they didn’t discuss it in detail, they mentioned it beforehand.
Yes, but it was the, it was a nurse that came out so whether she actually knew why I was there. That bit’s a bit hazy because I do remember because you always sign a form before you go in. And, you know, literally she brought me the form and then they took me straight in, so I wasn’t really looking at it. So no, that didn’t stress me in any way.
Okay. Did you feel under any pressure to take part?
No. No, there was no pressure at all. No, “This is this is a trial, this is what we want to do. Would you like to take part? Yes or no.” And the fact that you take the form away to sign it, you know, it’s – no, there wasn’t any pressure at all.
As in Sue’s case, people will normally be given a few days or even weeks to go away and think about it, and most felt this was a good approach. A few people did not want the thinking time they were offered. Rose said immediately she would take part in a trial but the doctor “seemed to get most perturbed by this” and insisted she take the leaflet home and read it. Others commented that having too long to wait and think could make people feel anxious, especially if they were keen to get treatment started. In some cases it may not be possible to have much time to think, especially if a decision about treatment is needed very quickly.
Wendy felt well-informed and the decision was left entirely up to her. She had two weeks to go...
Wendy felt well-informed and the decision was left entirely up to her. She had two weeks to go...
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I thought it was purely up to me, purely up to me. I think the balance was exactly right. They were factual; they explained why they were doing it. They said it was totally up to me, but that they felt I was a good candidate, and I sort of thought I was anyway because I’m normally quite a healthy person*. I thought they gave me exactly the right balance of information. And I, I think if they’d given me any longer than the two weeks, that would have been too long, because I would have had too long to dwell on it, and I wanted to get this treatment started anyway. And any shorter than that, probably not, because it, at least that two weeks gave me a chance to talk to other family members, have a look on the Internet and read up what I could on it, and mull it over with my family and talk about the impact on us.
*FOOTNOTE' A good candidate for a trial is someone who meets the eligibility criteria. This is not related to their general health, but only to the specific condition the trial is looking at.
The trial was explained clearly but Hazel felt in limbo when she was sent away to think about it....
The trial was explained clearly but Hazel felt in limbo when she was sent away to think about it....
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And then I was told that I had got something called DCIS [ductal carcinoma in situ] which I’d never heard of, and furthermore that because this was a new condition, they didn’t know how to deal with it and so there was a trial. And the whole trial proposition was put to me, very clearly, when we finally got to the point, and I was told I would have two weeks to go away and think about it, whether I wanted to join this trial or not. This was a huge dilemma, because I’d been told I’d got a condition that I didn’t understand.
I was told what the trial consisted of, clearly explained. But I went away feeling very let down, I suppose, because I had wanted to know what they were going to do next. That was the vital thing. I’ve had this thing removed - what was it and what are you going to do now? I knew women had radiotherapy, I knew they had chemotherapy. I didn’t know how they chose who had what or why they had it. All I wanted to know was what was it and what were they going to do next. And, of course, here I was in a sort of limbo, having been invited into a trial and sent home to think about it. They gave me the telephone number of Cancer Bacup, it was then called Bacup at that time. They gave me a small leaflet on I think it was tamoxifen, but very, very, very basic. And I was sent away to think about it.
Merilyn gets on really well with the research nurse and feels comfortable talking to her. That...
Merilyn gets on really well with the research nurse and feels comfortable talking to her. That...
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I mean, how important do you think it was that you got on well with nurse? If she’d been somebody who wasn’t quite so personable, would that have made a difference to you, do you think, in terms of saying yes?
I probably would have given it a lot more thought, and it, you didn’t have a lot of time for thought, because I actually went in on the Monday morning and was having my operation on the Tuesday morning. So it wasn’t the sort of thing that someone approached you and you had a sort of a week or a couple of weeks to sort of think about it. So, it must help if you’re comfortable talking to somebody. If I wasn’t comfortable I, I’d probably, I don’t know, maybe I would’ve had to talk to somebody, I don’t know. But I felt very comfortable, and I thought myself it was a good idea, I didn’t have to discuss it with anybody.
What was particularly good about the way that she did it, do you think?
She’s probably done it to a lot of people. Obviously with anything if you do it enough, you get quite good at it, don’t you?
And if you were trying to pull out - because we use this site for medical training and nurse training - if there were some key things you’d try to pass on to student nurses about the way that she talked to you, what would you pick out?
I don’t know. I don’t suppose you can really teach somebody. It’s, [sighs] I don’t suppose you can really teach somebody how to put somebody else at ease. It comes with experience really. Well, yeah, it would come with experience, it’s not something you can teach somebody. The more, it’s like the more you do something the easier it gets, I would have thought.
As in Merilyn’s case, the importance of having a good rapport (connection) with staff was a common issue, whether or not people had to make up their mind quickly. Often people said they wanted to trust someone to advise them. On the other hand, Rose said it would be a bad thing if people said yes just because they got on well with staff. There is considerable debate about how much information is ‘enough information’ to be sure consent can be properly informed. (See also ‘Information and questions about clinical trials’).
Even as a doctor who likes to have lots of information, sometimes when she is severely ill she...
Even as a doctor who likes to have lots of information, sometimes when she is severely ill she...
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I think, well it, it depends on the disease and the illness etc. etc, you know, because there are some points in time when you’re just not capable of really thinking about anything else, you know, a cancer trial or something. You’ve just had the diagnosis, you’ve got other things on your mind, and then you just want to trust your doctor, I think. Well, I personally, in moments of my own severe illness, despite the fact I’m one of these people that loves lots of information and like to make my own decisions, I’ve often at that moment just thought “I’ve got a doctor I trust. I’m not even thinking about this. You do what you think’s best and, you know, because I don’t want to think about it. I’ve got other things on my mind.”
It is important for staff not to try to influence you. If you say yes just because you like the...
It is important for staff not to try to influence you. If you say yes just because you like the...
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When they were presenting the two different treatments to you, did they talk to you about what they thought the benefits and harms of the different treatments were?
No. I think this was purely and simply because it was your choice. They couldn’t be seen to be influencing you, I would have thought. They, no, they just literally said what it was about and that two hundred and fifty people would have just radium and that’s, this was because there’s some dispute over some people say you should have radium and chemotherapy, others say, well, they’ve had lots of success with radium. No, they, I think that really it would have been wrong for them to be pushing for any treatment. You know, I think they were very good in that they didn’t really try to influence me in any way.
And did they share with you their own uncertainty about which treatment? I mean, did they say to you, “We simply don’t know”?
No, nothing. No, no, no.
Right.
Just purely explained what it was about. As I say, you’ve got a lot of literature to read, about different kinds of cancer and all different treatments. You’ve seen the handbook. But no, the doctor didn’t try - and I think that was right - that they didn’t try to influence you in any way. And you can see where, if the patient didn’t get well, if the doctor had tried to talk them into chemo and radium I mean they, they could have turned round and said to the doctor, couldn’t they, “Well, it was because of you, and I like you so much that you--”. And I think this is good that it’s done at the very beginning, because you don’t get that you’re attached to anybody. You know, any nurse or any - but I think for the cancer specialist nurse that must be quite difficult, because they must be constantly ringing her. And I, you know, I a couple of times rang her. But they must, because they don’t understand.
There should never be any pressure on anyone to join a trial, however little time is available. Virtually everyone recalled being told it was their decision, and remembered staff making every effort to explain but not to influence them. Just occasionally people sensed that health professionals were really hoping they would say yes, even if they did not say so out loud. In one case, Elizabeth felt under a bit of pressure from the consultant when he came to see her after her operation. She said, “I felt that was the main thing behind the consultation, really, getting me on that trial.”
If someone had mentioned the trial earlier on it would have been less of a shock when she was...
If someone had mentioned the trial earlier on it would have been less of a shock when she was...
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I think it’s quite difficult to, to put trials in the mix of everything else that’s going on. And I suppose maybe nowadays people are talking more and more about trials, and being involved with them, but actually I think I was a bit shocked that that came in the package as well as dealing with everything else, that you don’t expect that that’s going to come. And maybe if I’d, somebody had said to me “Well, you know, you’re doing very well, you’ve had your surgery, it’s looking fairly good. It may be….” If somebody had partly introduced the idea that there might be the possibility of a trial that might be suitable for you, so that it had been dropped into the equation little by little, it wouldn’t have been quite such a shock when suddenly the first appointment you have with the oncologist is, you know, “Are you going to take part in this trial?”
Whereas you hadn’t thought about it before. You’d thought, “Well, it looks like probably I’m going to have some chemotherapy”, but I hadn’t really thought about the fact that you’re going to have to make decisions, and I think it’s very difficult to make decisions at those points. And maybe if somebody had said at the beginning “Well, you know, you may need to discuss or may need to think about whether it’s appropriate that you take part in a trial.”
So at what stage might they have done that, do you think?
Well, somewhere between having the operation and seeing the oncologist, I think, you know. Maybe the Macmillan nurse could have come round and said, “Well, look this is what’s happening.” I think it’s just keeping people, tabs on people so that they are in the loop of what, what’s likely to happen. But suddenly to come out with, you know, “You’re going to get, you know, there’s this trial you’ve got to make a decision about.”
Okay, anything else?
I’m just worried I’ve said too much, really, [laughs] that I’ve gone and blown everything and told everybody that trials are rubbish, whereas I don’t think they are, because I think, you know, there needs to be trials. But I think they need a bit of thought of how, how it’s handled and how it’s introduced to people at a very vulnerable time. I think that’s probably the major message I would say, you know. However much they want to include people in trials, however much they want people to take part in trials, they have to appreciate that people are going through life-changing or adaptations, and it can be very difficult to take these things on board, however urgent it is to make that decision. It is difficult to get your head round all sorts of decisions that have to be made at that stage, when you’re taking on board all sorts of life-changing facts. So I think that would be fair to say, [laughs] that, you know, at the end of the day you do need trials, but actually it needs to be handled quite sensitively at a difficult time in somebody’s life.
Approaching patients raises practical and ethical difficulties for staff.
Doctors may want to protect their patients after breaking bad news, but they should not be afraid...
Doctors may want to protect their patients after breaking bad news, but they should not be afraid...
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I think people should be encouraged to do that because it’s part of being in a community, a citizen of a community, really. It’s part of that community contribution that people can make. I know that when you, you know, you have a, an awful diagnosis it can be really, it can, you know, throw you and sometimes, you know, it can’t, you don’t want to think about other things. But I think also professionals perhaps shouldn’t be scared of asking people. I think when it’s something sensitive there’s a feeling perhaps that [intake of breath], ‘Ooh well, I wouldn’t want to overload with, you know, getting them to do something else.’ And I know from what I’ve read from the GP angle on this that, that there is something about the nature of the GP-patient relationship that makes the GPs very kind of protective of their patients. And perhaps they should be a little more relaxed about it, that people are, they should, you know, these things are, should be offered to people and it should be part of the routine. And if you know that, if there’s an expectation that if you’ve got something you might be offered this, I don’t think it would be so taboo and feel so difficult.
I mean, I do think that there should be more simple advertised messages out there. I don’t, I don’t know that generally people would even think about it. I don’t know. We don’t get sort of advertised messages about, ‘Would you like to be involved in, in research and this is where you can contribute.’ We have to sell it to the general public as being something that is a really good benefit to - okay, you’re ill, or maybe you’re not ill, but, you know, in terms of NHS trials a lot of it is with people who are suffering from something, then this is something that you can do that that would actually help for the future. So I - yeah, I think there should be much more open discussion about it and much more, some simple messages -where you can find the information, if you want to get involved in research these are the benefits, and, and do some advertising. There should perhaps be some, something, some money put into advertising.
In the trial Lester chaired it was hard to approach patients with CJD (Creutzfeldt-Jakob Disease)...
In the trial Lester chaired it was hard to approach patients with CJD (Creutzfeldt-Jakob Disease)...
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With the study that you were co-chairing, what was recruitment like? Was it quite easy to --
No.
-- get people involved? No?
No. Well, for a start there aren’t many people who have CJD, very low numbers. And so therefore any numbers that you get - the more numbers the better, but there just fortunately aren’t many people with that disease, so therefore there weren’t high numbers. And one of the biggest problems is there is such a short timescale between diagnosis and death, generally speaking it can be about four months, that by that time people say, “No, no, just let, let matters take their rest.” Because unless it was a silver bullet type thing, it isn’t going to work. So from - what happens with CJD typically, the first symptoms come up about fourteen months before death, but you don’t recognise them as CJD, you think they’re other things, depression or schizophrenia. And it’s only about four months generally before death that people say, “Gosh, we know what it is.” And so recruitment’s not great because, you know, what difference can taking the drug for four months make? Now it has made a difference to a couple of people taking pentosan, but that’s, that’s by the by. With, the challenge for researchers with drugs that have a – or with diseases that have a quick sort of lifespan is to get to the diagnosis early. And to be fair to the researchers they did all they could to communicate with the people who are likely to see some of the symptoms early on. They communicated with GPs and neurologists and people like that. But the trouble with a rare disease, you can write and say, “Look, if you’re seeing a young person with these sort of conditions, can you just think a little bit it might be CJD?” But because there’s so few, most GPs will never see a case in their lives. So they read it and say, “That’s interesting” and they’ve got a million other things to do. So had we been able to find people who still had a year to live, if you like, then I think recruitment would have been hugely greater, because there would have been more of a chance.
Many people we spoke to remembered staff being very careful to say that the trial might not bring them any personal advantage, while others, particularly in drug trials, felt they were being offered the possibility of extra benefit. Wendy, for example, said the professor told her she was an “ideal candidate” and “led me to believe it was a really successful drug, and that’s why they were trialling it with other people.” Staff who are very committed to a particular trial may try to ‘sell’ it to patients in subtle ways and they may be unaware that they are doing so.
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. (See ‘Feelings about being allocated (randomised) to a treatment group’). This underlines the importance of staff being very careful about what they say and how. Patients may feel that there are benefits from participating, such as extra monitoring and appointments, or a feeling of helping others, but they need to make these judgements based on unbiased information about the trial. (See also ‘Reasons for taking part in a clinical trial – personal benefit’ and ‘Reasons for taking part in a clinical trial – helping medical science and other people’).
Patients are often unfamiliar with hospitals and research, and some people we talked to felt staff did not do enough to explain who they were and what organisation they worked for. One day Danny noticed a staff badge saying ‘Research scientist’. She said, “No-one told me that I would actually be being handled by research scientists. Now, I don’t know if that’s someone with a biology ‘O’level or whatever, or they’re doctors. I don’t know. I haven’t got a clue.” Marie was also not sure who she was talking to about the trial. (See also ‘Funding and publishing trials’).
Marie did not realise at first the doctor talking to her about the trial worked for a drug...
Marie did not realise at first the doctor talking to her about the trial worked for a drug...
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In the consultant came and met me in the haematology day clinic with a doctor and introduced this lady doctor as a doctor that is dealing with other forms of treatment. My consultant didn’t say a word. He sat there and let this doctor talk to me about this trial and then she said, “Well, what do you feel?” And then I said, “If it’s a life-line* I can’t refuse it as long as the conditions are all right.” The only other thing that my consultant said was, “I thought that’s what she’d say.” But it didn’t turn out to be for me.
So was that lady doctor from the drug company, do you think?
That lady doctor, [tut] there were two. There were two doctors on this, on the letter headed note paper I looked for my own consultant and he wasn’t there. This lady doctor I had never heard of before but the other doctor, he has always been at the local hospital for years and years and years. This lady doctor I don’t know but I was told by another lady doctor, when I told her that I was refusing the treatment and she asked me why, and I said, “I didn’t like the conditions.” And she said, “Oh.” And then I said, “I didn’t realise I was dealing with a drug company. I thought I was dealing with research from the local hospital.” And she said, “It is a drug company.” She said, “What happens is”, she thinks that the drug company pay the local hospital for the use of the hospital and allow them to do the research.
* FOOTNOTE' It is important to remember that you can have treatment anyway outside the trial and do not have to consent to a trial in order to be treated. Sometimes a new treatment will only be available as part of the trial, but in most cases there will be other treatments available.
Gill thought it was important for researchers setting up trials to think ahead about how people would be asked to take part and talk to staff who would be approaching patients on their behalf. Otherwise they might not be aware of important practical problems.
Researchers need to think carefully about how they recruit patients, and consult at an early...
Researchers need to think carefully about how they recruit patients, and consult at an early...
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And I mean there is no kind of manual, as far as I can see, that says, ‘This is how you should do it.’ Every research project is different, so you’ve got to weigh up all sorts of issues around your recruitment. But that, but maybe it’s not - maybe the way in which research is funded and bid for, you have relatively little time, really, to respond [laughs] to bids. And I would have thought that probably the bit that might get missed out is paying a lot of attention to that first part, really - getting that methodology of the recruitment and the approaches and how you’re going to do that right. And talking to the right people, if you’re recruiting patients making sure that you’ve, you know the clinical setting in which you’re going to recruit and that, that you’re not going to be doing something that just won’t work.
I mean, I know from years of ago being involved in health visitor studies, I mean I was on the management side, managing the research within a, this was in a hosted organisation. But, you know, researchers would come and talk to the health visitors having got their protocol all sorted out and probably got their funding, and were then talking to the health visitors to say, ‘We want to recruit mums and babies in this area and do this and do that.’ And the health visitors would say, ‘Well, I can tell you now that that won’t work because they won’t turn up to this or they won’t do that or.’ And so the whole – and I’m amazed, I would hope that less of that happens now but certainly ten years ago that was common. You just think,’ This is such a waste.’
If staff are not consulted or properly involved, they may not explain things properly, or may put people off. A participant in another study of antenatal screening was told by her midwife there was a local trial of screening in pregnancy for sickle cell anaemia. She recalled the midwife encouraging her to say no.
“I just felt so overwhelmed with tests that when she asked about it I just thought, “I can't do this.” And then she was behind the blinded envelopes, she had these two envelopes and she was just holding them up saying ‘Say no, say no.’ And I was going to say no anyway, but I said no, and she said, ‘Oh that's good, it's so much paperwork’.”
(See also ‘Information and questions’, ‘Difficulties finding a trial to join’, ‘Public awareness and involvement’ and ‘Messages for health professionals’).
Last reviewed September 2018.
Last updated September 2018.
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