Whatever the treatment, test or intervention that is planned as part of the clinical trial the details will be explained both in the written information you receive and by your research nurse or clinical trial practitioner. They will support you and your family throughout your time in the trial.
Every trial has a set of strict guidelines about who can take part and who should not be included. These are called eligibility criteria and they make sure that trials include the sort of people who may benefit from the treatment.
Inclusion criteria determine who can take part; some trials only include people in a certain age group or at a particular stage of their illness.
Exclusion criteria state who cannot take part. For example, many drug trials do not allow pregnant women to take part as there may be a risk to the unborn baby.
Before you start a trial you may have to have to some extra tests to see if you are eligible or to make sure that you are not likely to be at risk of being harmed by the treatments being tested. These screening tests could include having a scan or a set of blood tests. None of these tests or procedures can take place until you have given informed consent by signing the consent form.
You will be monitored regularly during and after the study. You will have regular tests and you may be asked some extra questions about how you are feeling. Sometimes this means going to your hospital or GP more often than you would normally, so bear this in mind before you agree to take part. You may want to ask how many extra visits will be needed and consider how convenient this will be for you. Sometimes you will be able to claim back any extra costs you have. This will be explained if it applies to you during the informed consent process at the beginning.
You may also be asked to fill in questionnaires or keep a diary and quite often have extra blood tests. All of this will be explained fully in the patient information sheet.