Inclusion criteria determine who can join a trial. For example, some trials only include people of a certain age, or at a particular stage in their illness. You may have to have a medical examination before a trial to assess whether you are suitable to take part. (See also eligibility criteria and exclusion criteria.)
You cannot be entered into a trial without signing a form saying that you have given your informed consent, except in extreme circumstances (for example, if you’re admitted to hospital in an emergency and you’re unconscious). If you sign this form, you are saying that you believe you have been given all the important facts about a trial, you understand them and that you have decided to take part in the trial of your own free will. Even after giving your informed consent, you are free to withdraw from the trial at any time without giving a reason and without it affecting your healthcare.
Within the context of healthcare, an intervention is something that is given to a participant as a treatment. For example, giving a drug is an intervention. Counselling and surgery are also interventions.
Within the context of a clinical trial, the ‘intervention arm’ is the name given to the group of people receiving the new treatment or treatment plan.
Investigational Medicinal Product (IMP)
Investigational Medicinal Product (IMP) is a term used by regulatory agencies to describe a trial drug used in a clinical trial
Individual participant data meta-analysis is a specific type of meta-analysis where the researchers go back and look at the records for each participant who took part in every trial, instead of using summary information about groups of participants (records are anonymised so the researchers don’t know participants’ names). Then they bring these individual results together. This makes the results of the meta-analysis more reliable and enables researchers to look at how treatments have worked in different groups of participants, e.g. age group or sex.