What you should be told about a clinical trial

Before you take part

The trial team must tell you:

• what the trial is trying to find out

• what the different treatment groups are

• what the likely risks and side effects are

• what the benefits may be

• what tests or check ups you will have

• how often you will have follow up appointments and for how long

• whether the researchers would like to keep any blood samples, tissue samples or other samples to use for research in the future

• what will be done with your personal information and who will have access to it

They should also explain where you are likely to have treatment and whether you will need to stay in hospital or not.

The patient information leaflet

Full information about a trial should all be included in the patient information sheet (PIS) or patient information leaflet (PIL). A member of the research team will go through the information with you. And they will give you a copy to take home so you can read this in your own time. It will cover all the points listed above.

You can refer back to the PIS when you are deciding whether to take part in the trial or not. You can also discuss it with your friends, family, GP, cancer specialist or nurse. The research team should give you plenty of time to think about things and ask any questions you have.

Giving your consent

Before entering the trial, you must sign a statement to say you have been told, and understand, what taking part in the trial means. This is called informed consent.

You can't enter a trial without signing your agreement. You will have a chance to ask any questions you like if there is anything you don't understand. You may want to bring someone along with you to help make sure all your concerns are addressed. Please remember that you can say no to joining the trial if you don’t want to. It is entirely voluntary.

Informed consent is an ongoing process throughout the trial. So you should always be able to ask questions, and get answers to them, while you are in the trial. You can also choose to stop taking part in the trial at any point.

Information about side effects

If the trial is looking at a very new treatment, the research team may not know much about the side effects yet. But you should be told everything they do know that is relevant.

What if I want to leave a trial?

Remember that you can withdraw from a trial at any time, without giving a reason. This will not affect your ongoing care in any way. Your doctor will discuss other treatment options with you.