it’s very much a pity that the, the recent news – good news is not news, is it? So the trials where those volunteers were paid, and then had a really adverse reaction, I’d rather we didn’t get that kind of publicity. I think we need to get the more positive kind, yes. We need people to come forward and say, I did a trial. I didn’t suffer any- – well, maybe you did – but that it’s better, for the good of everybody it’s better that you should go through some discomfort yourself. Mm. Otherwise we’ll never make progress.

When a person is in the system it’s not always at diagnosis that’s the best time to talk to them about different things, because at diagnosis, you’re, Oh God, I’ve got this, I’ve got that, I’ve got the other Well, you’ve got to give people a chance for that to register, and it’s all very well saying, Well, we’ll give patients all the information there and then That is not necessarily the best time to do it. But I think in general, I think there could be more awareness made regarding clinical trials, whether it be through newspaper articles, or wherever where people get the opportunity of really understanding what they are and what they’re about, rather than, I suppose, the general consensus of opinion is still the guinea pig effect. And it’s not necessarily the guinea pig syndrome kind of thing, and I think that’s perhaps what needs to be more expressed and more explained to people.

Well, there’s a lovely opportunity now with the National Health Service at age 60 to start bringing in the concept of, Why can’t we afford everything we want to do? We’ve moved forward so fast and so far and we’ve got so many treatments for so much and so on, but what we’re really after is a healthy nation, which is what the Health Service wanted in the first place. And, you know, here is the story, a simple linear story about what’s happened in various obvious illnesses. Make it visually and intellectually simple to absorb, and say, This is all part of your legacy. Your Health Service is here. This is how it got to where it is. I mean, I went to a lecture given on leukaemia by my husband’s consultant, which was a lecture meant for a lay audience but – or maybe not a totally lay audience, but one with some interest and some knowledge in medicine. And it described the development of treatment for leukaemia from sort of the days when you dished out arsenic and, you know, how a lot of the medicines are still arsenic-based, none of which I knew. And it was visually easy to absorb and it dealt with an entire chunk of, you know, haematology, basically. It wasn’t the whole of haematology, but a whole lot of it. Well, that, you could do that story for a lot of things and explain how research has played a role and how that has been a plus and a minus. You know, We know more. We can deal with more. But it costs more. And it takes time to acquire this information. It’s a ten-year lead from, you know, thinking that something looks as if it’ll work to getting it working. And those sorts of information are, you know, that’s not around, generally. People, people are talking a little bit in those terms. But I think perhaps if you could get a bit more responsible journalism and a bit less sort of knee-jerk journalism, which you could build on now, at this moment, it’s a terrific opportunity.

I think public awareness needs to be raised and I remember thinking at the time that they missed a fantastic opportunity in Eastenders because – I can’t think of her name now – was diagnosed with breast cancer Peggy Mitchell was diagnosed with breast cancer, and they could have brought that into the storyline brilliantly, fantastic education opportunity, because millions of people watch that. But that, that was a missed opportunity. So I think things like that that are in the public culture could be used for education and raising the awareness and people’s willingness to participate. But I think if approached properly and if it’s explained properly I don’t think many people would refuse to participate.

I think raising awareness within the professions is as important as raising awareness within the public.

Do you think there’s still work to do there?

On the – I think so on the non-medical side. I think physicians are used to clinical trials, they expect clinical trials, they know they’ve got to test drug A against drug B, but anybody outside medicine, so in any of the therapies, physiotherapy, or surgery, or anything like that were they don’t have to go through a trial to get a licence, it’s probably not in their professional culture to do trials.

Well, it’s [sighs] it’s probably difficult to raise – well, to raise awareness about any scientific issues in the general public. So, well, I mean there are occasionally nice programmes on television about various aspects of science. So if this brilliant doctor who is very passionate about medical trials and who can also present it in a Royal Institution Christmas lectures or anything of that kind, I mean I would gladly watch, and I’m sure the general public would gladly watch. And what else can you do for, to expose science to the public? I haven’t thought about this, so I don’t know, no. I mean.

Schools or things in, in school science lessons? I don’t know.

Well, that’s for – well. I mean, well, clinical trials obviously they are a very complicated mechanism and I’ve only seen a tiny glimpse of it from sort of my own experience. And well, it involves all of medical science, as I understand. You know, in every branch of medicine you run trials, more or less. It involves maths and statistics, right? So, well, obviously you can raise public’s awareness about all those issues first and foremost. You know, I don’t think you should concentrate on teaching clinical trials to people but, you know, I mean, I wish I was taught more at school. I was in school, at school in Russia in completely different times and a completely different country, but still as a member of general public here in the UK, I wish there was more exposure to important issues in medicine, on the whole. Social issues related to medicine, right? Scientific issues related to medicine.

Yeah.

Maths and statistics is very important and a lot of people underestimate how important it is, right? So that would do a great, a great help to medical science, if, if people were more aware of statistics and statistically based decisions, not just playing the lottery, but actually knowing what probability means, and what is their chance of winning the lottery as opposed to dying at an operation. And, you know, they, these are the issues.

These, this is the, this is I think the, the link that’s slightly missing from an average, even from educated people, people’s knowledge often. And after that, after people have got better exposure to medicine as a whole, to maths and statistics as a whole – there must be other aspects in clinical trials that I don’t even know about – then all these components put together will already give people slightly more understanding of clinical trials, and they will be slightly more prepared when they are in a situation when they have a medical problem and they are asked to take part, to take part in a medical trial.

I suppose one of the things I think about now is that for thirty-five years I, you know, I didn’t think about trials at all, and yet I just expected my doctor to sort everything out. And that’s almost childlike, but I didn’t have time or the inclination to think about anything else, really. And I, we live in a more enlightened time now, I probably wish that I had known more about this sort of thing. And, and, you know, it’s sort of one of those things, we talk about citizenship, I think it could easily come up in sort of, in education now, really. Not to make a big deal of it, but just so that people are aware of what a, a trial is. So that people would be more ready to make some decisions if, if the opportunity came along or the chance came along.

I don’t think they are aware of the, what goes into the trial, and how long it takes for it to, the product to be developed, and all the machinations of the, the lab work and everything like that. I mean it’s just, you know, they just think it’s I know I’m being generalistic now – but they, I think, I don’t think they believe what, they understand what goes on, in actual fact.

Do you think there’s more that we should be doing to educate people about trials and clinical research?

I think there could be lots that you could be doing, but I don’t know whether anybody would actually be that interested [laughs]. But you know what I mean? I mean, I’m interested because of my background, and I’m very passionate about all this sort of thing, but a friend of mine well, I mean, a lot of my friends wouldn’t even, you know, they would be more interested in horses or, you know, whatever they’re doing. I don’t think – I think it depends what makes your pump thump.

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].

After that time I chaired the, one of the charities for people with human BSE founda-, human BSE*, called the Human BSE Foundation. And it was at the time where there was a lot of media attention, and the Medical Research Council and the Department of Health knew they had to do something, because basically every time somebody mentioned CJD it would get on to the front page of the tabloids. So they held a workshop, a CJD trials workshop, where they invited carers of people who were still alive with CJD, bereaved parents or friends, and researchers, trialists. And it was a well-facilitated meeting, where they explained to us all what they meant by trials. So the whole, this was for the first time the world opened up. Randomised, double-blind, placebo-controlled – all those phrases that meant nothing to me came tumbling out. And they were just seeking our views, which I thought was excellent really. And they explained what trials were. And the question they were asking mainly was, What sort of trial structure did we think would be acceptable to people suffering from variant CJD And we gave our opinions and they produced a report. And at that time there was no known therapy that would be of any help. But there were some trials going on in America. And in fact it was one of those trials that a UK father saw on the website and flew his daughter over to America so that she could participate in this trial. And it was quite a well-known case. So really this was a bit awkward for the government, because they, it was known as a British disease but here they were without any form of trial or learning structure, and people were going to America. So they realised that we really ought to crack on and have a trial. And the best bet at that moment was something called quinacrine.

*FOOTNOTE’ Human BSE is human bovine spongiform encephalitis, an alternative name for Creutzfeldt-Jakob disease (CJD).

But anyway, the trial was decided. It would be run in England and, or in the UK, and they set up what they call a trial steering committee. I didn’t know what that was, but it’s just like the overview group, the group that sits above, if you like, the researchers, the chemists, the scientists, and has a range of people on it who can actually give advice and say, Well, this doesn’t feel right. This is.. – not in respect of the data. Not in terms of the scientific stuff that’s coming out, but more, Does this feel right? Does it feel right for people Anyway the, I was asked if I’d sit on that committee and I said, Absolutely Ellis by then was, had died, so it was just an interest of mine. And they asked a man called Iain to head up the trial steering group. And he’s, you’d call him an academic, I guess, but an interesting man, and he agreed to do this job, but only on two conditions. One, he wanted what’s called a systematic review done of all other therapies, so that we could see if quinacrine had been trialled before and what the results were. And he also insisted that he’d only do it is if a layperson co-chaired it with him, on the basis, What does he know about the disease Well, the Medical Research Council suggested he might like to meet me. We met, we got on. And so for the trial steering group there were two chairs, myself and Iain.

And what did we do? As the trial was set up, what happens is that the researchers design a protocol, a sort of a set of rules of what they’re going to trial, and also importantly what they’re going to look at as important indicators if something’s working or not. And it’s a very, very complicated document. It starts with what is going to be done to people on the trial and it ends up with what they will look at to see if there is any benefit. So you could say I suppose in its very simplest form with something like CJD, where people always die, Do people stop dying You could use that as a marker. Do they live longer So all of that sort of thing was brought in. It then has to go through to an ethics committee, a group of people, a broad range of people who sit two or three steps away from all of us, and look at it and say, Look, does this feel right Because I guess people who are going into a trial, participate in a trial, need to be reassured that there’s no self-interest at stake here, that the researchers, it’s not just one of their pet themes, a little idea, Let’s give it a go So therefore the structure around setting up a trial, before it even gets going, before even the first person gets into it, is very pure.

I guess sometimes it could be too pure. There could be times where an ethics committee would look at something and say, Wow, that’s just too risky. We don’t think that’s fair Whereas the people who were going to take part in it would say, Actually, it is fair. There’s nothing else going on for us. We want it And again, CJD would have been a good case in point, because if you are caring for somebody you love and they are definitely going to die, you may well feel it’s better to take a bit of a chance than no chance at all. So when we went to the ethics committee, I went as an observer and sat at the back, not commenting. But had the ethics committee said, Well, we’re not sure about thi, I would have been happy to stand up and represent the families, if you like, and the patients, and say, Well, look, actually just think about it. Let’s take a balance on it So ethics committee sets up, everything gets going and the trial starts.

Something I was going to ask you a while back when you were talking about the Mental Health Research Network. Was it your experience with the trial that kind of inspired you to get involved in that?

Yes, it was actually. My, it was basically because my psychiatrist was very active in clinical research. He was always writing papers and doing presentations and stuff. And I wanted to be part of that buzz. I would go to a lecture or something and think, Wow, this is really interestin because a lot of research had gone into stuff and it fascinated me. So basically I found out a bit more about it, and I made some contact. And it was really nice getting in touch with my local office. I was welcomed in. I wasn’t treated as, Oh, you know, you’re not importan or anything. Because in actual fact now, basically the way governance arrangements are around research is that you have to have obviously service user involvement. So, and they didn’t just accept me because they knew they had to involve me to get their funding – because I know that that happens, where clinicians say, Here, sign here. Fill in that box. Then I can get my mone you know [laughs], type thing. I’ve heard that happen, I’ve heard where people have been taken out for dinner and, you know. It rarely happens now. But we are still having a bit of tokenism, though, where actually the meaningful involvement is still not quite there. However, I was fully, fully involved and, you know, and I’ve got my place within the department, and I’m involved in all aspects of stuff. I’ve even, I even thought up my own proposal for a research project, which got a whole team together. And I sat in this room with all these academics. I could not believe it. There must have been about seven or eight psychiatrists all sitting in a room, and with a statistician and everyone, and all sitting there. And I’m sitting there thinking, Wow

And I said to the one psychiatrist, I’m thoroughly embarrassed. I’ve got you all here for half the day And the one psychiatrist said, No, I think this is absolutely wonderful And we got actually shortlisted on one of them, but then we didn’t get past shortlisting. And I was really, really upset. And I remember the one researcher who had put the proposal together said, O he said, don’t worry He said, Research for Patient Benefit will be here for years, so we can keep trying And I just thought [laughs], you know, it was just so lovely the way he said that and kind of, you know. And so it’s on the back burner. But we haven’t finished yet. So, you know, so for as long as, as the Institute for Health Research will be there, my proposal will be on the back burner. So that, that was lovely. And also I go on courses and stuff and I’m encouraged to do training and, you know, I help out on stuff. And I do have my own specialist area, which is around personality disorders and eating disorders. However – and psychological therapies – however I recently was approached by a professor who specialises in schizophrenia research, and it was quite nice to be asked to, to help out on that. And that wasn’t tokenistic because he was applying for money, but he genuinely wanted my advice knowing that I worked with other mental health service users. And it was really nice, you know, and it, it was a nice feeling. And I also went away and learnt more. And I also got given a great big textbook as well. So it was great.

Yeah, I’d had so many bad experiences in my treatments and I felt that – well, I wanted to know, really, how research, how research was being conducted into cancer treatments. And I saw, in one of the journals I get, there was an advert for consumers, patients, to join the consumer liaison group which is part of the NCRI, which is National Cancer Research Institute, I think. So I applied. I rang up and asked them what it entailed, and so I joined the consumer liaison group. I really wanted to go into – they have study groups, and each study group has two or three consumers in it, but mostly they’re research scientists, doctors, nurses, professional people. And of course I wanted to go into the lymphoma one, or the haematology one, but they already had enough consumers in those, so I ended in the complementary therapies group. And I must admit, during my treatments I tried every complementary therapy under the sun [laughs]. So I knew a little bit from that point of view about them so, so I went into that group. And that’s where I’ve stayed.

And what do you do?

So – it’s a good question, really. Sometimes I wonder if I’m, if I’m any use at all, but when we have our meetings, any issues that come up we simply give our own experiences and our own opinions, as patients on these, these issues. That’s about it really. Some of the people are involved in research, even the patients, but I’m not. But they don’t seem to mind that.

Mm, so.

I just give my opinion as a patient.

So do they bring kind of research proposals to the group or–?

Yes, that’s right. Yeah. Yes, research proposals are brought and discussed within the group and then it’s decided whether they can, pass them as, you know, let them carry on, sort of thing.

I mean it is almost inevitably a form of tokenism, but it can still be very useful just to have a few people who are not, who don’t have a vested interest in recruiting as many women as possible to the trial, who, you know, don’t have a vested interest in the questionnaires all being filled in completely without any kind of missing questions and this sort of thing. Just people who have got a common sense approach to what it’s like being asked to take part in this kind of research, and who can raise questions to which it would be helpful to have answers early on rather than having people, you know, turning round later on and saying, Well, I don’t think this trial is very well organised, so I’m not going to take part. Now I have no idea what the drop-out rate in this trial is, you know, whether twenty per cent of women in the control group are just not bothering to fill in the questionnaires because they think they’re quite silly [laughs]. I don’t know.

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.

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.

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.

Thinkwells an idea that came up with some of the patient groups that I work with. There’s a lot of ordinary members of the public out there who, who actually are interested in research and who would like to participate, like myself. You know, you never get invited by your doctor, and lots of questions out there about health, you know, Is it better to do, to really do a lot of exercise three days a week or a little bit every day? you know, and whod be interested and willing to participate. So the idea was we would set up a website where people could come together, and it’s, and it’s called The International Network for Knowledge about Wellbeing. So we’re concentrating on things that make you healthy, things people can do for themselves. And the idea is that the public come, they have their questions, we can look at the evidence and give it to them. We’ve also got a risk communication website so that people can have a look. If someone tells you Oh well, you know, there’s a one in 10,000 chance of, of dying from cervical cancer, and it reduces tenfold if you go, if you have screening, well, what does that mean? Is that a big risk? Is that a small risk? What other risks do we take like that? So there’s a database, you can compare it.

I prefer to give people information, but they need to be able to use that information sensibly. So this is part of what’s on the Thinkwell website, a risk communication website, so they can go and play with risks and if people tell them it’s a 0.006 risk, Well, what does that mean? Well, it will translate it back into, Well, that means that six, you know, in every 10,000 people might have it. So it translates it into more meaningful formats for people, and also enables them to get together and if they want to run a trial we’ll help them run a trial, and they can sign up to a trial. So one of the things we’re exploring for example is there’s – we don’t know, what we have in this country now, if you have a baby they have what’s called active management of labour, so there’s these things that they do to you, it’s all predetermined. Okay? And one of the things that they will do is the moment the baby’s born they clamp its cord. And there are people who argue that’s not a good thing. A third of the baby’s blood is in the placenta and cord and the argument is if you leave it a little bit, more blood will go back to the baby and it’s less likely to be anaemic. There’s an argument for delayed cord clamping but we don’t knows what’s right.

But health care professionals haven’t done this trial, but women would like to know. So our idea is that we’ll get women to randomise themselves on the internet, women who are having babies who are interested in the question will say, Yeah, I’m interested in participating in this research. I’m willing to be allocated by choice to choose delayed or early cord clamping. They’ll come on, we’ll say, Now toss the coin right, go and ask for delayed cord clamping in your birth plan. You go and ask for early cord clamping. And then we can compare the results because we’ll have two groups of – but it’s the women who are doing that trial, really, and we’re just taking their results with their permission to see if there is actually any difference in outcome.