What trials mean to us?

Interview with David Collier, Research Fellow, Clinical Pharmacology Department

What do clinical trials mean to you?

They are often the best way to find out if a new medicine or treatment works in a particular condition. Because a trial involves comparing a new treatment or idea with an existing treatment it has the good effect of forcing everybody involved to think about how good the current treatment is. For many illnesses and conditions the current treatment can be quite good already and then the new treatment will be compared with this. For others where there is no current usable treatment then a dummy tablet or placebo may be used as the comparison. For most studies you get the new drug or treatment before the existing treatment which is decided by chance. Today it is less likely to be decided by the flip of a coin and much more likely done down a telephone or using a computer programme.

Because the results of clinical trials are used to decide whether new drugs or new treatments get accepted for use in the “real world” then it’s very important to be able to prove that the studies were done properly. To be able to show what happened during a trial there is usually a good deal more paperwork and far more checking of what happens during a study than there would be back in the “real world”. Fortunately most of this extra paperwork is done by the study staff and not by our patients. Clinical trials do often involve some extra checks, examinations or other tests, but at least these are easy to explain and many people find the extra information they provide reassuring.

The “deal”, if you like, with clinical trials is usually very simple:

You only have to do things in your study that you are comfortable with.
You are always free to stop taking part in research at any time should you no longer feel comfortable about taking part.
In some studies which involve following participants for some years we do ask patients that if for some reason they don't like us or they don't like the tablets then they don't have to keep on coming to see us or take the tablets. All we ask in this situation is to kindly allow us to check with their GP every now and again just to make sure they are still well and they haven’t had any major problems. This is because we do like to make sure that even at the end of very long studies that we know what has happened to all of the patients to make sure the treatment or method we used doesn’t carry any long term risk that we haven't thought about.
None of us is perfect and we can't expect our patients to be either, so if for some reason you can't make an appointment in the clinic then all we ask is you give us a ring before the time of the appointment and let us know that you can't come for some reason, or even afterwards so we know that you are well and we can re-book the appointment for you.
If you have any problems with the study treatment or anything that you think we should hear about then we're always happy to hear from you and we usually aim to see you on the same day in clinic if we need to, otherwise we usually book people in the next day or the day after depending on what fits in best for you.

What are the bad things about taking part in a clinical trial?

Most trials do involve people taking part and spending more time than it would usually take for standard treatment. This is usually mostly because of the extra paperwork needed to prove that what happens to you is well enough recorded to be able to convince people that never meet you that the study happened in the way it did. For some people, the extra time taken is often with the study doctors or nurses so some people don't always see this as a bad thing.
Most but not all studies involve extra tests or physical examinations than you would normally have in the usual run of treatment. Many of these extra tests are routine like extra blood tests, but some are more specialised like special x-rays or scans.
Many studies involve new drugs or new treatments of which we have limited experience and if so will explain how much we know about the drug already and how the new tests should help us learn more. Testing a new medicine involves carefully recording any bad or good things than happen during treatment and these all being collected together to make sure that the experience from all the people in the trial helps us to learn about how useful the new treatment is.
Obviously if we knew the new treatment we were testing was going to be effective then there would be no reason for a trial and we would give the drug to everybody. This does mean that there’s always the possibility that the new drug or treatment is actually harmful or is less good than the existing standard treatment. To protect you against this all studies include safety measures to ensure that the experience from all of the patients in the trials, especially if it is bad, goes back to the study headquarters and if a pattern of problems emerges this is used to protect the rest of the subjects in the study as soon as possible.

What are the good things about taking part in a clinical trial?

Many people take part in clinical trials because they want to help other people.
Some people do clinical studies so they can get access to a treatment which is the very latest and which might be better than the standard therapy.
Others help with trials because they like the fact that clinical trials staff often have more time to spend with then than would normally be allowed for in a hospital or surgery setting. The relationship between study staff and patients and volunteers is often more relaxed than is possible in a busy clinic setting.
It’s worth pointing out that we are very lucky here in the UK that our patients can get access to treatment for most of the problems that we think of treating for a clinical trial. This means that you always have a choice and don’t have to come to the trials unit itself if you don't want to.
Taking part in a trial is a good way to think about your health in general and may enable you to think about improving your health in ways which were not directly connected with the study.
Some of our study patients volunteer to join our interested patients group. 400 strong, these patients have helped us with all sorts of questions and contribute to focus group sessions, taking part in meetings, helping us with teaching medical students in our lecture theatres about what it feels like to have a particular problem, or even to take part in a study. Other patients have made video films about the experience of other patients and one of our patients has even developed as part of a school exam syllabus which covers the conduct of clinical trials as part of a course in science and society. We have a link on our website to there.

Past Studies
Current Studies
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But more importantly, this is what trials have meant to our patients.