Clinical Trials

Well, I knew it was only going to be a few minutes, because they went straight on to the main computer. It was a long few minutes, like, you know. And actually what happened was the computer was down when I went on it, you know. And she says, we made a joke of that. I says, “You see this?” and carrying on, and she had to go away and use another computer. And she came back and that’s how it was up, you know. I, as I said, I would have accepted, but I wouldn’t have accepted radiology. I don’t think I could have. It was, I think it was just the inconvenience – well, not the inconvenience, that’s the wrong word. It was having to go there every day for eight - and then again I said, I asked, she said, “It could come back. You could go through all that and it could still come back”, you know. And she explained the monitoring and she explained what radical surgery was, you know. She said, “Them’s your three options. You can have any one of them.” But I went with, well, I says, “Well, I’ll go for the computer”, thinking it would come up with monitoring, and that would take the decision away from me. But it didn’t. It come up with radical [surgery]. So the decision was made for us, you know, which was, in a sense, it made it easier. Because I know computers are not infallible but, you know, they’re, when they’re putting the right information in you should come up with the right answer, shouldn’t you, you know? So I mean I was, I was happy to go with that.

 

They put in all the - well, from what I, the way I take it, they must have put in all the symptoms and everything, all the tests they had done previous to that, you know. And they put it all on the computer and it come up with that. Because I’d done all the biopsies by then, you know, on the prostate. They had took a bit of the prostate away and, you know, and they cut it up, whatever they do with it, you know.

Well, I hate computers, you know. But I don’t know why I let, I don’t know why I let the computer make the decision. But I thought, I was putting, I put a lot of trust in the nurse who looked after us, and I knew she wouldn’t just go on the computer and say, “Oh, we’ve got a spare date for the, do a bit of surgery here. We’ll practise on Ronny” you know. But I knew, you know, I knew she would put every detail in that she had to and come back with a genuine - I knew by her face what she was going to say, you know, by the look, I thought, “Oh, yeah.” But I was happy to go along. I accepted her, I trusted her. I trusted her.

 

 

No, no. That never crossed my mind, you know. As I say, when they done my pre-ops, two weeks before I went, when they told, actually told us and they actually done all that, I think they thought, “Well, he mightn’t come back”, so they done them all, you know. But, no, I would, I’d made up my mind and I wouldn’t have.

 

 

Well, all the time I had been going I was a nervous wreck, you know. I was. I was very bad, like, you know, nervous. And they could tell. And we used to joke and God knows what about it, you know.

 

And, how can I say it? It’s, I was getting frightened and more frightened as it got nearer and nearer, because I knew, well, it’s going to have to be something or other, you know. 

FOOTNOTE: Randomised trials are done when we don’t know which treatment is best, in other words when the relative merits and disadvantages of different treatments are uncertain. It is important to realise that in about half of trials, the new treatment will turn out to be better, but in the other half it will turn out to be worse. This means that, going into a trial, everyone, regardless of which of the treatment groups the computer allocates them to, must have similar chances of a good outcome. If, in spite of the treatment uncertainties that the trial has been designed to address, people would strongly prefer one of the treatments being compared, they should not volunteer for the trial. 

People are allocated at random to one of the groups in the trial, often by using a computer programme. Their personal characteristics are not taken into account when they are allocated to one or the other treatment. Random allocation helps ensure we are comparing two very similar groups of patients, so if one group does better than another, it is very likely to be because the treatments being compared have different effects, and not because of differences between the people in the groups. That's why random allocation to the treatment comparison groups is so important. 

 

I was in the hospital and I was visited by the consultant, and the first thing he said was that I was in a good position, which was unusual because I’d been diagnosed at an early stage, but he was very keen for me to consider going on a clinical trial to see if one particular combination of drugs was preferable to what was the gold standard treatment at the time. He told me all the facts and figures about it, and gave me a sheet, told me to go away and think about it and come back to see him three weeks later with a decision as to whether I wanted to go on the trial. And I took the information away, and it was a bit of a shock because my husband hadn’t really realised that I was going to need some chemotherapy as well. And we got home and we considered all the pros and cons, and I was in two minds whether to actually have any chemotherapy at all, or not, but a midway house seemed to be just to have the ordinary treatment, rather than going on a trial.

 

My son at the time was very keen that I didn’t lose my hair, which I would have done if I’d gone on the trials section of, the trial arm of the trial. And there were a number of other reasons I chose not to go on the trial. I felt that I’d been diagnosed at an early stage, and it wasn’t appropriate that I should have any stronger medication than I was already going to be having. I also felt I needed to have something in reserve if it did come back at any stage, and I didn’t feel that I needed to go overkill with medication that I was, it was being suggested.

I was given an information leaflet about the trial, about the drugs and the options, but the, once the consent forms were signed, it was, the randomisation allocation was done over the phone, from because it was a Cancer Research Campaign trial, so it was done through their headquarters, and then after that I got my tablets and started taking them.

 

I was allocated to the tamoxifen alone group, and like any trial there are advantages and disadvantages. The advantages of that was that it was just a tablet every day for two years, whereas the Zoladex [goserelin] one was an injection once a month for two years, or you could have them both together. So in a way I thought I’d got off lightly. But actually now that the results of the trial have been published, I think people in my situation now are routinely given the Zoladex, so I was probably not in the winning arm of the trial. But you don’t know that when you go into the trial and… there are side affects and risks of the Zoladex, which aren’t particularly pleasant, so everything’s a balance. So it didn’t worry me whether I was in the winning arm or not. It was the taking part that mattered.

 

No, I’m quite philosophical about it. So they, they didn’t know at the time. It was a new drug, can have nasty side effects, meant an injection every month whereas I, you know - no, I’m not bitter about it, no, not at all. 

We’ve got to be sure that the patients getting Treatment A aren’t in any way different from Treatment B. Now, every clinician or patient has got their own in-built prejudices or biases, whether they’re aware of them or not, so to overcome those you have to rely on either a list of random numbers on a table or a computer-generated one where they haven’t got any feelings or instinct. They just spit out a load of numbers, and all the odd numbers get Treatment A and the even numbers get Treatment B. So it’s a way of ensuring that the people within each group are as similar to each other as possible, that there are no systematic biases or in-built differences, that they’re not all older or fatter or more educated or, you know, all blonde people or, you know, anything like that. They’re not systematically different.

Because every individual has probably got in-built prejudices against one or other of the treatment options, and it may be that if you are of a certain type of person you would choose Treatment B and a different type of person would choose Treatment A, and therefore you get different types of person having the different treatments, and it’s the differences between the people that make the difference in the outcome and not the treatments. And when you’re analysing the data you can’t account for every known factor between the two types of people. You’ve got the crude things like age, socioeconomic group, sex, ethnic origins and stuff, but there’re all sorts of other subtle things that you might not record or have a valid way of recording it. But with randomisation they will be randomly split between the two groups.