Clinical Trials

When the findings had been analysed they sent you the report with a covering letter saying that, “This is the report that we’ve made”, you know. “It was published in the British Medical Journal.” And it gave you an overview of what the results were, and then it gave you the actual, the report that was submitted to the BMA [British Medical Association]*, or whoever it was. I think - no it was the BMA. So that they, so they sent you, they sent you the medical report, and sent you an overview so that you understood any medical jargon or anything that was in it. So they just, you know, it was very clear what they sent to you, so you’ve, you know, you fully understood and, you know, you understood the results of the survey or the trial.

 

 

Not really, because, well, because extra information helps you. You know, it was extra information in a straightforward way, very easy to understand, no jargon in it, you know - or if they did have some jargon in, they explained what, you know, the words meant. So it was very simple to understand, so it was good. So no, I mean it was almost like a foregone conclusion. You know, give you more information in a way that’s easily accessible and easy to understand, and it’s going to make it easier for you to understand it.

 

So, you know, I think it was. I mean, I’m glad I took part in the trial because, you know, it proves that it was worthwhile and hopefully now people will understand it, and they’ll be able to give people more information, and it will make other people’s decisions so much easier. And you just get a clearer way, some of them, you know - ‘Should I or shouldn’t I?’ or ‘What if I do? What if I don’t?’ kind of thing. It just clears it away and gets it clear in your mind about what you’re going to do next time.

 

*FOOTNOTE' The British Medical Journal is the journal of the British Medical Association.

 

Well, we had a big meeting about, about three or four years ago. And they were saying that the, you know, the results had come through and from what knowledge they’d found, certain drug companies were now changing some of their methods and going over to making, you know, the new type of tablets. I think a general feeling was that the new type of tablets they were using were more, more beneficial, you know, the sort of ACE inhibitors, that sort of thing. And also the, there was a lot of information about the cholesterol lowering, which was much more, I think it was more beneficial than they’d realised, it had more of an effect than they’d probably realised before, and that cholesterol lowering was a much more important aspect now than it used to be - because it had never really been sort of looked into in conjunction with lowering blood pressure. That was the first real major trial where it had been, been tested. So I think that was probably the, the major breakthrough.

 

 

Yeah.

 

 

Yeah, I was. Oh, yes, certainly, yeah. Yeah, I mean having taken part in it I was, you sort of, I don’t know, you feel part of the whole thing, so it’s interesting to know what they, what they found. And it’s also good to know that they, they now realise what an important aspect, as I say, cholesterol is. So that’s, yeah, it’s pretty satisfying.

I was very, very delighted and impressed when my psychiatrist told me at a follow-up appointment that I went to, that the paper he had written up had been accepted into the American Journal of Psychiatry, because I’d heard that, that it’s very, very difficult to get a paper published in there and that only the very best get stuff published. And I felt quite, quite touched that I was part of that process to help inform about a treatment. I hadn’t read the paper yet. So I was, I mean I think I was a bit nervous. But I was given a copy of the paper when it was published. And it was very rewarding for me to see that not only had I got better but also on paper that a whole group of people had got better. And it was evidence-based through the research. And it was published in a very eminent journal. And that for me felt like something quite special, because I knew I was then helping other people. And also spread the word about good treatment, because I knew then that other psychiatrists would be reading that, and thinking, “Oh, you know, this is something new. I didn’t know about it. This is really good news because before we thought people maybe didn’t get better.” Because traditionally BPD [borderline personality disorder] was seen as untreatable. But this ground-breaking research had shown that it was actually treatable. And this for me was quite important. 

 

I [sighs] I don’t remember. I actually asked to be given the results of that, just because, because I was curious, yes? So.

 

 

So if it’s published, then I would like to have a copy of that for sure, yes.

 

 

They should have an option. Maybe not everybody would think about it. I, it was obvious to me, again because I was a scientist, and, you know, and I knew this research would be published, and that’s why I asked. I mean, for somebody who’s not familiar with research maybe there should be a tick-box which asks them if they want a copy of the actual final outcome of it.

No. [Laughs] I’m very tempted, every year that they ring me up I’m very tempted to say, “How’s it all going? Is everybody alive still?” It’s not the sort of thing you ask really [laughs], and they wouldn’t tell me if I did ask that, so I never ask it. But of course the trial goes on. I think I would probably ask that sort of thing at the end of the trial because it’s actually a ten-year trial and I’m only in the fourth year now, so it’s quite early on in the trial.

But as I say I get very tempted to ask [laughs].

 

I would, I would, I would. Yeah,

 

But probably a few more years towards the end of the trial, because obviously four years is quite new.

 

No.

 

 

No, no.

 

I think it would be nice, but maybe somebody else wouldn’t want to know, but I think it would be nice for it to be offered if somebody, you know, does want to know.

 

Yeah, yeah.

As a person I would like more. I would like more information on the results. Perhaps that’s the type of person I am. I like to know results. Like I said earlier, I worked in research, and the results to me are quite important. Some people wouldn’t want to know the results. My husband’s one of these people that, you know, “Okay that’s what you’re going to do, so carry on and do it.” I’m a bit like a dog with a bone really [laughs]. I like to, I like to know how things are working, and I do ask, I do ask those questions. My husband sort of says to me, “You always want to know the ins and outs of everything.” I said, “Well, it’s my body. I’d like to know where we go from here. I like, I’d like to know what the results are.” And they’ve been, especially on this trial, they have been very, very good, and I know that I am the only one that has gone more than six weeks. So…

 

They are very open about this trial.

 

 

They are giving me feedback because I, because I’m asking. I think if you’re not asking, then perhaps you wouldn’t be getting that information.  

 

Well, it wasn’t automatically sent to me, but it was offered in the sense that my psychiatrist did tell me at one of my appointments that it was going to be published, and he did tell me about the results, very basically talked to me about the results, just to inform me. But I - and, you know, and he said to me did I, asked me if I wanted to see the paper and I said, “Yes” and, you know, and then, then I was, you know, given a copy. But I am also very aware that there are a lot of people who do take part in trials who never ever get to hear about the final outcomes, and also if the papers are written up and published, never given a copy of the clinical paper that’s published. And there are various reasons for that. One may be that, that the, it may be assumed that the patient doesn’t have enough knowledge to understand what a clinical paper is saying in terms of jargon and the way the statistics are presented. The other may be, of course, that, you know, clinical journals traditionally are held in the privy of medical school buildings or hospital libraries or, you know, online. Patients aren’t going to hold the privileged ATHENS number to get access to the journal.

 

So it, it is difficult. And if a patient - and some patients may also have this fear of contacting somebody, you know, like the great surgeon, surgical professor or, you know, the top-notch cancer specialist type thing, when actually they’re human beings just like us and, and they use our information. So I’m, I’m very aware that that happens.

 

 

I feel very strongly about this. One of the things that I do is I work with the Mental Health Research Network. And one of the regional areas, the north London hub of the network is, we’ve got, you know, I do work with, with them, and I’m very, very proactive in promoting the whole issue about discussing the outcomes with trial participants. In fact, I was discussing recently with one of the research professors, who was doing a trial which had a six-month gap in between when they did their first interviews and their second lot of interviews. We were discussing how they can maintain contact with patients and keep them in touch with it, without it being too formal. So instead of them getting a bland letter through the post saying, “Dear Mr Bloggs, how are you? We’re just checking you’re still participating”, how can we - and, you know, and keeping in touch right until the very end of the trial, and then obviously keeping in touch thereafter.

 

And one of the ideas we came up with was about a postcard. You know, you get a lot of junk mail in the post and these postcards that come in from companies selling themselves. Well, I had this idea that a postcard could be designed and it may be, the cost may be sponsored or incorporated into the trial cost. If it’s a drugs trial, the pharma company could sponsor that. If it’s a non-drugs trial, it could be incorporated into the costing. And this would be a really nice, bright coloured card, and it would just be pre-printed with a picture on one side and on the other side the researcher could just write a little handwritten note to that person. And then put it in a, a normal plain envelope, you know, and post it to all the trial participants.

 

And just basically keeping in touch with them and sending them a card every, maybe every eight weeks, right up until the very end. And then at the very end having a meeting to say, “This is what the outcomes were.” And this is kind of something we’ve taken on board, because it’s incredibly important not just to get people onto a trial, but to have respect and to share the information and the outcomes at the end of the process. And make it accessible information, so not just also dishing out a clinical paper that’s out of some journal that may be out of the reach of many, you know. So, you know, obviously arranging a talk or a discussion or an evening where people can come and just have an informal question-and-answer session and a brief presentation about what happened.

 

Well, not really. And that’s something that I also find very depressing, actually. Because again in the case where my husband was on a trial, they’d been trialling a particular drug for quite a long time on a European basis, and then they’d moved into just trialling it in one London hospital, but the European trial had pretty much closed, come to an end, and was being reported on. And I actually asked for the results of that, and I was told at the trial hospital that, well, they didn’t quite know when they’d be coming out but, yes, of course, possibly something could happen one day. I actually asked my husband’s consultant personally in a different hospital, and by return of email he sent me the results. They were there, they were possible, they were available, and they were not given automatically. And even when asked they were not exactly withheld, but it wasn’t made easy.

 

And that I do feel - I mean I don’t think my husband could have cared a pin what the results were - but I wanted to know. And in the ovarian one I certainly would like to know, because there are, there’s obviously, I mean, you know, plenty of opportunity for me at some later stage to be told I must be checked. And whether or not the blood test or the scan are a better way to do it, I would be very interested to know.

As far as the professionals are concerned, I think they do need to think very carefully about the problem that, yes, a lot of medical advance comes, has come through military sources and originally the soldiers needing one form of cure or another. But we aren’t numbers. We are individuals, who need to be taught to be intelligent about what we are doing, so that we can collectively be politically more sensible about our whole medical world. And I think that means they have to be much more careful about consent forms, and information about trials, and giving results back and discussing, and making sure that the trial builds in the funds for that - because it’s not a big amount of money that’s needed, but trials are always short of money. And I could never talk to the research nurse on [husband’s] trial because he was always too busy. He was sweet and very nice, but he was run off his feet, because there wasn’t enough money. And it isn’t a big amount of money needed to talk to people. So, you know, build that in to your funding.