My experience of course has been within cancer, mainly, at the beginning, but very quickly realised that it was utterly generalisable, as has since been worked through, and now we’ve got structures and so on to facilitate patient involvement, patient and public involvement. it’s always difficult to find the right word. That, I think, is the best description’ patient and public involvement, rather than consumer’, which has a rather materialistic connotation, unfortunately, and user’, I think, sounds really rather horrid.

they’re unavoidable in some instances, in some concepts, contexts you have to use those words, but generally I – and quite often the lovely word people’ is very useful, because after all clinicians are patients and I work with clinicians who are patients, and I work with clinicians who are cancer patients. So we’re people, aren’t we? I’m a patient whos gone somewhat professional in direction, and they’re professionals whove gone horribly in the patient direction. So we all should have a common aim, which is how to improve any intervention that is offered to patients whove got diseases and things wrong with them.

So coming back to people in general, quite obviously huge swathes of the population can’t get involved. they’re too busy, like I was prior to this time. If I’d been asked ten years before, I couldn’t possibly have done anything at all about it.

I was too busy doing what people do which is earning a living and bringing up your children and occupied with all those things, neither the time nor the mental energy to get to grips with it. It so happened to me at a time when I, when I could do something about it and was delighted at the possibility of immersing myself in this huge problem. But many people can’t do this.

And again, this wretched word representativeness rears its ugly head time and time and time again. I’ve been asked, Do you think you’re representative?’ Well of course I’m not. But I did say very early on – actually at a health select committee when I was, had this fired at me in a health select committee, Are you representative?’ And I said, Well, no, but I’m being open about what I’m doing. If there are, if there is anybody out there who wants to contribute to what I’m saying, or to disagree with what I’m saying, they’re perfectly welcome to do so. And I said, And I haven’t had any of that, so I can only assume that I must press on, in the belief that what I’m doing is for the good of humanity. And I, and I’m going to press on, but dissent is the very spice of doing these things, so yes, let them come.

I’d advise them to approach it slowly, carefully, taking account of as much advice as they wanted or could get. I would warn them that it can be very difficult to cope with your nearest and dearest, because they want the best for you, but they don’t know what you want. And it, they can very heavily influence you in a direction that you might have actually preferred not to go in. But you can’t discount it, you see. This is one of the factors, I think. You asked – the previous question, you can’t actually say until the moment arrives. So I would warn them that they would have to be, try and be detached from the seriousness of what it was they were trying to decide, be very objective about it, which of course is impossible because it’s an utterly subjective thing, and it’s where the subjective and the objective collide that the problem lies.

If somebody offered you the chance to take part in a trial now–

Yes.

–and you were confident it was well designed would you say yes now?

It would depend entirely upon the trial, but if I thought if it was, I think, yes, I would. And if it suited me as an individual, at that point in my let’s call it disease progression, and my – yes, if it was suitable. If it was tailored for me – which is after all what all trials ought to be, isn’t it? They ought to be tailored for the group of people that are trying to be helped. So I think the only answer to that can be yes, but I never say a qualified – an unqualified yes, because there always are circumstances and values that you bring into you decision-making that are not apparent until you’re actually at the point of making a decision.

You can’t make a decision for anybody else, and you can’t make a decision of your own in the future, in the same way that you can’t retrospectively decide what you would have done if. So, as far as it goes, yes, I’m for trials, but I think it would be foolish to say that yes, I definitely would because it would have to depend upon what it was, when it was, and whatever it was.

I have a passion to see that people have a working knowledge of what a trial is before they’re asked to participate in one. I don’t really know how I sort of knew. I perhaps I didn’t know very well, but I think with my previous work I had quickly had to get to grips with things. It was how I functioned. But if you know what the purpose of research is, if you know what a, testing treatments is about – that it has to be by comparison, that it has to be done in the very best way possible – if you understand why it’s necessary to group people – commonly called randomisation, which is not an awfully good word, because it’s sounds so haphazard.

it’s haphazard in one sense but in another sense it’s very particular. If people were brought up to understand this – and it’s been found that young children, I was having a conversation with my granddaughter whos six and a half, I can’t remember what we were talking about, but she inherently had this realisation that you’ve got to compare things before you can decide which is best. Work on the children. Make it clearer that this is the only way to reduce any sort of uncertainty about anything, and to do it with those people who are very expert at doing it. But it needs a lot of disciplines to do a good trial, all sorts of disciplines, a team effort, including the patients and the public [laughs].

So I think we’ve got to a point where there is a huge amount of activity, but it’s not very clear quite what that activity has been, and also the quality of the involvement, that’s an important point. You can have token names, but what did they do? Were they really valuable? Were they allowed to be valuable? Now, this is an unknown quantity. Now, if you consider that over all the disease areas, let’s even confine ourselves to cancer, there’s all sorts of cancers, there’s all sorts of involvement, there’s all sorts of methodologies. It’s very difficult to assess how successful it’s been, but we have to try and do it. And when I consider that when I first came into this there was no evidence, and now there is accumulating evidence and there is a possibility of deciding what the benefits of it are, and what the drawbacks of it are, that had been properly researched by people very well qualified to do this type of research, we’re beginning to get an idea that there is more benefit than harm. We’ve also got to decide what the cost is. But overlying all that is the sort of moral imperative. Isn’t it right that we should all be involved, and we should all make it work? It should be our responsibility as much as the clinicians’ or the researchers.

So there is a rightness about it and this was spotted by Ranaan Gillon, the ethicist, oh, way back in about 1993. He voiced that, that it was surely right that we should be doing this. Now, I have felt it to be right – quite obviously otherwise I wouldn’t have spent all this time and energy on it. But I know there’s a lot of other people who think it’s right to do it. All we’ve got to do now is get it right, which is much more difficult. I sometimes say that it’s in some ways much easier for patients who want to get involved now, or clinicians or researchers, because there’s so much about to help you. But on the other hand, because there’s so much about to help you, there’s so much more to learn before you feel you can get started. And that’s a pity in a way, because I think it can be intimidating. People think that, ‘Oh I couldn’t possibly do that. But people have different things to contribute, and some of it may be an only, an apparently very small way, but it all contributes to the whole. And other people want to get in right up to the elbows in a very different way.

And I started to read about DCIS [ductal carcinoma in situ], to find out that it was a very complicated condition and that not a lot was known about it either, that because before screening – and remember this was at the time when screening was just being introduced in the early nineties – there really wasn’t a great deal. I learned that, for example, there were five subsets of it. I learned that some were, could be quite serious and could develop into invasive cancer. I learned that others were of a quite different type and would probably never ever develop into anything. And I thought, Well, this is extraordinary. it’s not one disease. it’s many, it’s a whole spectrum of things, all the way from not necessary to find i to perhaps it’s not such a bad ide.

And then I thought, Well. And then there were pieces of information about size and margins and all sorts of other things. And then I realised I didn’t have the facts of my own case, another huge information lack. How much had they excised? What were the margins? What type was it? Was I oestrogen-receptor positive or negative? All these had bearing on my coming to an assessment of how serious or unserious this thing was and, more importantly, how I could set it up against the trial that they were offering, in order to judge whether I might want to participate or not. And the more I was finding out, the more I realised I couldn’t possibly give informed consent.

Now I ought to refer to the particular trial which had four arms and bear in mind it was after I had had the excision biopsy, complete excision of the abnormality. The, the four trial options were’ nothing further, a full course of tamoxifen for five years, a full course of radiotherapy, or radiotherapy plus tamoxifen. Now this was explained to me actually in the consultation, so I knew what the four arms trials were. The first thought that flew into my head, which happened to be a pretty good thought in retrospect, was, How serious is this condition? And how can they expect me to be randomised for a condition that is a non-invasive cancer?’- which I also understood, in other words it hadn’t spread into the surrounding stroma. How can I be content to be randomised to such four very different arms?’ And then, of course, jumping ahead a little, when I’d found out a little more about it I realised that I could have the sort of DCIS that had the potential to develop into invasive cancer, and I might get the no further’ arm. On the other hand I might get noth-, I might get nothing, or I could have a full course of radiotherapy and five years of tamoxifen for something that was never going to cause me a problem in my lifetime. So that was a couple of weeks later.

But even my gut instinct told me that this was a trial that I couldn’t see how I could possibly join.

Also there was a huge imbalance in the arms of the trial. I didn’t know this at the time, but the clinicians, quite a number of whom did not think that radiotherapy was a wise choice for DCIS*, so they only entered patients into the tamoxifen arm of the trial, comparing tamoxifen without tamoxifen. Now I didn’t know that, and yet I was labelled as prejudiced when I raised queries about radiotherapy. And I thought, ‘That’s not fair. I have a view, and it comes from a very personal viewpoint of having the disease. Clinicians seem to be allowed to have this view that they don’t like the idea of radiotherapy and yet it was kept secret from me and I’m not allowed to have it. [laughs].

So if you’d known that you could have entered a tamoxifen versus no tamoxifen arm would you have considered that differently?

Oh I certainly would have considered it differently. I don’t think it’s possible with hindsight to say whether I would have entered that arm or not, because I think hindsight is a very difficult thing and I would rather not go there. People usually want to press you to say, ‘Well, what would you have done?’ You know, ‘Would you have gone into that?’

And I would have certainly considered it. I would have given it much more consideration. And as a matter of fact when I spoke to the family about this my daughter said to me oh, and this was actually after I’d refused to go into the trial. We then had of course had to decide what we were going to do about it, bearing in mind that we all appreciated the uncertainty of knowing what to do about it. So you have to confront this huge uncertainty head on, outside of the trial, and not just myself but the clinician as well, and your family of course, because they’re interested.

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

They were very even-handed, again. And again, bearing in mind what it was, I think this is quite remarkable. They were very fair about it all. And this was, this was another thing that it raised in my mind that they had to go into sort of clinician researcher mode to put the trial to me. And of course I had the contrast of how they were afterwards when I decided not to go in for the trial, because then they were in ‘normal, in inverted commas, clinician mode – in other words asking, negotiating with me, making the decision with me, about what we’re going to do next. And it’s quite different from being a clinician researcher, but they did it very well. The explanation was clear and they were even-handed.

The other thing that occurred to me at the time was, when I’d found out a little more about it quite soon after, I realised there was this huge contention in the profession about what to do with this wretched disease. And I, I imagined and I think I’d heard from a nurse somewhere – I can’t quite think how. And I realised that within a team, within an institution or a clinic that was offering a trial, you could perhaps have a radiologist, and a surgeon, and a couple of breast care nurses, and anybody else you like and they might have different views on this trial. And I thought how are they going to present a sort of united front on, ‘We are doing this trial. Particularly as I’d found out, as is quite obvious, that this was a very contentious trial. It fascinated me to think how they could operate as a team when it was such a difficult thing.

I found that quite, quite interesting. And I found it to be the case. I even heard of cases, of nurses making faces at patients behind the surgeon, saying, ‘No. [shakes head] [laughs] And I thought, ‘Oops. [laughs].

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.

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.

We just have to advance by comparing in a very rigorous way how we go forward with treating patients, otherwise we’re going to be stuck in not knowing. So yes, I thought trials were a wonderful idea, but it did occur to me that if I’d been on the trial working party, I would have some things to say about the information sheet. I would have had things to say about the end points. I would have had things to say about the possible outcomes, and about the feasibility of this trial. Because a huge amount of money was spent on it. It was a very costly trial, because of all the contention, I suppose. So there are economic aspects that need taking account of. Yes, I’m totally for clinical trials but they must be good quality clinical trials.

And, as I found with the people that I have spoken with and worked with, and indeed the clinicians more locally, I think it can only come about by a partnership between patients and health professionals, because we each have something different to give to, to devising any project, concept, trial that needs to be done. And the prior-, prioritisation of topics as well. You know, what is important to patients? What do they, what would really make a difference to their care? What do they want to know? Because they’re at the sharp end. They know what they want to know. They know what research would benefit.

And I think those patients that have become involved in this are able to stand back. They don’t do it – they do it based on their own experience because they know what it feels like – but they do it in a sort of detached manner. They have to become professional in their own way, in order to realise that this is an activity that’s undertaken on behalf of future patients. You do it on the basis of what you’ve learned today, what you’re learning today, but you’ve got to go forward and I think to do it in partnership is really the only way to do it. So yes, I’m totally for it. But the trial has to be well designed, well balanced, and presented in such way as to make sense to those who are going to participate. Otherwise it’s pretty futile if they don’t understand what’s happening.

What do you think are the characteristics of a good, well-designed trial?

Hmm. It’s easier to describe a bad one, isn’t it? And this is why I got involved, because I was invited to participate in one that was not balanced. The first thing that springs to mind is of course that it should be, let’s call it a legitimate comparison. It has to be utterly legitimate. In other words it has to be a comparison with, that is based on first of all the best standard treatment, a thorough overview of what is known on that topic – you can’t just have a bright idea and plunge in and ask for money. You have got to do your homework and find out what is known about this particular topic, before you even go, go there. I think I suppose the next requirement is to sort out, prioritise the question itself. In other words, how are you going to frame the question? It has to, I think, accommodate what are the important things about the thing you’re researching.

So framing the question that means something to both the clinician – in other words the sort of scientific, clinical treatment aspects – together with the aspects that the patient wants to find out. It’s, I think, no good having a trial that’s got an outcome that is meaningless. How are you going to get people to participate if they can’t identify with the purpose of the whole comparison? So it has to be a fair comparison.