Beating bowel cancer together

Clinical trials

Medical research trials that involve patients are called clinical trials. Clinical trials aim to look at whether the treatment being tested is safe and how well it works compared to what is currently available to patients. They can look at a range of different areas including prevention, diagnosis, treatment and quality of life.

Some clinical trials test new treatments or interventions but others involve new ways of using existing treatments, for example, by comparing different doses, timings and treatment combinations to maximise patient benefit.

This page tells you how you can find a trial and what things to think about before you give your consent to take part in a trial. We’ve also suggested some questions you might like to ask.

Finding a trial

The researchers will be looking for people who meet a list of criteria, such as a certain stage or type of disease or treatment history.  If you would like to take part in a clinical trial, ask your healthcare team if you are suitable for any current trials in your area. You can also find a list of trials on the UK Clinical Trials Gatewayand the Cancer Research UK websites.

What are the different phases of treatment trials?

Treatment trials go through a series of phases to test whether they are safe and if they work. All new cancer drugs are tested in the laboratory before they are given to people.

Phase 1 trials involve a very small number of people in a specialist research unit. They aim to discover what the most appropriate dose might be, and what the side effects are. If the drug is effective and a safe dose is found after a number of phase 1 trials, it could progress to phase 2.

Phase 2 trials, still involving a small number of patients, aim to discover which types of cancer the treatment is going to be most effective for. They may also check the best way of giving the treatment, the ideal dose for effective treatment, and the side effects and consequences of this pattern of treatment.

Phase 3 trials compare how well the treatment works compared to current, standard treatment. This phase often involves much bigger groups of patients from many different hospitals, often in different countries. They can gather much more information on the effectiveness and side effects of new treatments, and often last several years or more. They often involve ‘randomisation’.

Phase 4 trials are carried out after a drug has been given a licence which proves it to be safe and effective for patients. These studies usually investigate the long term risks / side effects of treatment in standard use. Phase 4 studies are not required for every medicine.

What is randomisation?

Randomisation is a way of randomly allocating people to treatment groups. This is often done by a computer in order to avoid bias. If there is no current treatment, a new treatment may need to be compared with a placebo (dummy treatment). Randomisation aims to make sure any difference in results is due to the treatment received.

Taking part in a trial

The advantages of taking part in a clinical trial include:

  • possibly having access to a treatment that isn’t normally available
  • having extra check ups and support
  • feeling you are taking control over your cancer
  • helping to improve treatment and care for people in the future

The disadvantages include:

  • not necessarily being able to choose which treatment you have
  • possibly not knowing whether you are having a real drug or a dummy (placebo) drug
  • finding the extra check ups tiring or difficult to fit into your everyday life
  • possible additional procedures, such as blood tests
  • the risk of unknown side effects

The research team may send you a copy of the results once the trial is finished.

Giving your consent

If you decide to take part in a clinical trial, you will need to sign a form to give your informed consent. This means you understand what the trial involves and you agree to take part.

You will usually have time to ask questions about the trial and to speak to your family and friends before you decide whether to give your consent. If you change your mind, you can leave a trial at any time without giving a reason.

If you decide to take part in a trial, the research team will send details to your GP and hospital healthcare team. Nobody else will have access to your medical information. The trial results will not identify you or give any personal details about you.

Cancer Research UK have detailed information about taking part in clinical trials.

Questions to ask

The research team will give you detailed information about the trial before you agree to take part and they will answer any questions you might have.

Here are some suggested questions >>

 

  • What is the trial testing? For example, a new treatment or combination of treatments?
  • How long will the trial last?
  • How long will the follow up period be?  
  • Will I need to visit a hospital or GP for follow up or can it be done via telephone?
  • Will I know which treatment I’m getting?
  • Does the trial include a dummy (placebo) drug?
  • What are the benefits and risks of taking part in the trial?
  • What support will I get during the trial?
  • What treatment would I get if I decide not to participate in the trial?
  • What expenses can I claim?
  • Will I still see my usual healthcare team during the trial?

 

 

Updated August 2018. Due for review March 2019 

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