What is it like to take part in a clinical trial?

Patient involvement in research is vital to improving care and treatment

Information kindly provided by Elka Giemza, Unit Manager at the NIHR/Wellcome Trust King’s Clinical Research Facility

Medication question mark graphicTaking part in a clinical trial or study can be daunting, but at the same time extremely rewarding. However, without patients helping us with our research, we would not improve the care and treatments we can give.

I have been asked to write a few words to tell you about clinical trials and what is involved. Here is a little information on several aspects, including finding out about clinical trials, advantages and disadvantages of taking part and what happens when you are in the trial. I go on to discuss the process of giving your permission to do the trial and if you do, the options you have to discontinue the study if you want.

In the UK, we have an organisation called the National Institute for Health Research (NIHR), which is the NHS branch of research. The mission of the NIHR is to maintain a health research system in which the NHS supports outstanding individual working in world class facilities, conducting leading edge research focused on the needs of patients and public. They fund a great deal of research and training for professionals wishing to enter this field of medicine.

A clinical trial is any research study that allocates human volunteers or groups of people to one or more health-related intervention to measure and assess the effects on health. Clinical trials are sometimes called interventional trials. Interventions include pharmaceutical drugs but also include cells and other biological products, surgical procedures, radiologic procedures (like x-rays and scans), devices (like a blood glucose monitoring device), behavioural treatments (like psychological therapy), and preventive care, etc. This definition also includes Phase I to Phase IV trials.

We run trials to increase our understanding of how to treat a particular disease or condition, which may benefit you, the participant, or others like you, in the future. You might learn more about your disorder by attending and having more opportunity and time to discuss your condition with your doctor. You may, or may not, be the first to benefit from taking part in a trial.

If you are unwell and interested in taking part in a clinical trial, your doctor or other healthcare professionals may know of research being carried out that may be right for you. However, the most convenient way to find out more is to use the Internet. You can find information on the online registers of clinical trials, such as the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) or see the clinical trials information from NHS Choices. These sites collect information from different registers to provide a central database of clinical trials.

Several charities also keep details about trials for specific conditions. For example, The Migraine Trust works closely with researchers investigating migraine and provides details of current trials here. Other health charities also have user-friendly information about some clinical trials. Some charities may not formally publish lists of clinical trials, but may know of some that are relevant to patients with particular conditions.

There are advantages and disadvantages of taking part in a clinical trial. The main reason for carrying out trials is to assess whether one treatment is better than another. During the trial, your treatment and progress may be monitored more closely than if you were receiving the usual treatment. Trials are very important in helping find better treatments. By being involved in a trial, you will obtain information and evidence that may be helpful to you in the future, as well as helping to provide others with the best possible health care.

One of the disadvantages of being in a trial is that, as with any treatment, you can’t be sure of the outcome. You may be given a new treatment that turns out not to be as effective as the standard treatment. It is possible you will experience unexpected side effects. You may have to visit your place of treatment more often, or have more tests, treatments or monitoring than you would if you were receiving the standard treatment in usual care. You will, however, be informed of all the visits you would be required to make, before you agree to take part.

It is important that you fully understand what is involved before joining a trial. If you are asked to take part in a trial you are free to say yes or no. For people under the age of eighteen, a parent or guardian may have to give permission. The doctor or nurse organising your treatment will talk to you about being involved. They should explain the possible risks and benefits. If you take part, you should make sure you understand and receive all the information you want before you give your permission. This may mean taking some time to think about it and talk it over with family or friends, unless a decision is needed urgently because of your medical condition. If you decide to take part, you will be asked to sign a form to say you agree to take part in the trial and have understood what it involves. This is called giving your informed consent.

Sometimes it may not be possible for you to be involved in a particular trial. For example: your condition may need to be at a particular stage; you may not be allowed to receive another treatment at the same time; some trials seek people with certain illnesses and conditions, while others need healthy people; some trials need people of a certain age; there may already be enough people in a particular category who have joined the trial.

Before you join a trial, you may need to have tests to see if you can take part. This is generally known as a screening or baseline visit. This will give the researchers more information about your health before you start treatment, which will allow them to tell whether there has been an improvement at the end of the trial. During the trial, you may have more tests to see whether the treatment is working. It may be possible for the tests to be carried out as part of your routine care, or you may have to make more visits than usual to your GP or hospital.

Whilst being on the trial you may wish to stop taking part if, for example, your condition is getting worse, but you can also choose to leave at any time without giving a reason and without it affecting the care you receive. Alternatively, if there are signs that the treatment in a trial could be unsafe, the research team or the regulators will stop the trial.

I hope this explains a little about taking part in a trial and what is involved. If you would like to know more, another source of information is the King’s College Hospital website.

This text is taken from Migraine News journal, Issue 113, September 2016.