There are lots of specialist words used in cancer research and cancer care in general. To help you to understand how research is described, we have explained some common words and phrases you may come across.
Arm of a trial describes a group of patients taking part in a clinical trial. For example, there could be a treatment arm with participants getting the new drug and a control arm with participants getting the standard treatment.
Blind trials are trials where the participants do not know which drug or combination of drugs they are receiving, or if they are not getting the drug at all but are receiving a placebo instead.
Chief Investigator is the person responsible for leading, designing, and reporting on the entire study. This will always be a senior clinician or academic.
Cohort is simply a group of participants taking part in the trial. There can be more than one cohort or group in a trial, each receiving a different specific treatment.
Consent is the participant agreeing to part in a clinical trial after they are sure they understand the study, its risks, and their rights. It involves detailed discussions with the clinical team running the trial and the participant having the opportunity to ask any questions before they sign a form agreeing to take part in the trial. Even after giving consent, the participant can still withdraw from the trial at any time.
Control group is the group of patients taking part in the clinical trial who are not getting the new treatment. They will still get the standard treatment and perhaps a placebo. The control group is vital to a clinical trial as it lets researchers compare the new treatment to the existing treatment and measure any differences in results.
CTIMP stands for Clinical Trial of Investigational Medicinal Product, which is a research study that is testing a new drug or medicinal product in humans to assess its safety and whether it works.
Double blind trials are clinical trials where both the participants and the researchers running the trial don’t know who is receiving the treatment being studied and who is not.
Early Phase trial is a Phase 1 clinical trial that looks at whether a new treatment is safe, has any harmful side effects and tries to find the best dose of the treatment to use.
Efficacy means how well a treatment or drug works in the clinical trial and whether the participant is experiencing the benefits the researchers think should happen.
Funder is the organisation that is paying for the research to be carried out. Funders can include government agencies, charities, or industry organisations such as pharmaceutical companies. Some trials may have more than one funder and sometimes funding is given to individual researchers as a grant to carry out the trial.
Host or research site is the organisation where the research takes place, like a hospital or clinic, and which is responsible for the day-to-day running of the trial. There could be lots of sites taking part in a trial both in the UK and around the world.
IMP stands for Investigational Medicinal Product, the drug or medical product that is being studied and tested in clinical trials to assess its safety and efficacy.
Informed consent is the participant agreeing to part in a clinical trial after they are sure they understand the study, its risks, and their rights. It involves detailed discussions with the clinical team running the trial and the participant having the opportunity to ask any questions before they sign a form agreeing to take part in the trial. Even after giving consent, the participant can still withdraw from the trial at any time.
Interventional trials are where researchers give a treatment or new drug to see what effect it has on participants.
Multi-arm trials have several treatment groups and a standard treatment or control group. Individual treatment groups might be getting different treatments or drugs, and researchers may add new treatment groups as new drugs become available for trial.
Observational studies are where researchers watch and collect data from participants without influencing what treatments they have to find out what happens naturally.
Open label trials are studies where both the participants and research team know which drug participants will receive before the trial starts.
Overall survival means the length of time a patient lives, regardless of whether their cancer grows.
Participant or Patient Information Sheet is a leaflet that explains the trial in plain language. It includes what will happen, how long the trial will last, and what the risks might be. You should read the information carefully and ask questions about anything you don’t understand.
Participants are the people who volunteer to take part in the study.
Personalised medicine means tailoring treatment to each patient’s unique situation instead of giving the same treatment to everyone with the same type of cancer. If your clinical trial is using personalised medicine, your treatment will target your cancer’s specific genes and proteins making your treatment more precise.
Placebo is something that looks like the real treatment, but it has no active medicine in it. It is used so researchers can compare whether the treatment being tested works better than no treatment. Sometimes the researcher and the participant won’t know who is getting the treatment and who is getting the placebo.
Principle Investigator is the person in charge of the trial at a particular hospital or site.
Progression-free survival means how long patients live without their cancer getting worse.
Randomisation means putting trial participants into different groups by chance (like tossing a coin). This makes sure the groups are made up randomly at the start to ensure fairness. You cannot choose which group you are part of in a randomised trial and there is a chance you might be put in the control group that does not get the active treatment.
Recruitment is the process of finding and enrolling patients who are suitable for the clinical trial.
Regulatory Authority in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA). They are responsible for checking that all trials are safe and follow the law.
Research or host site is the organisation where the research takes place, like a hospital or clinic, and which is responsible for the day-to-day running of the trial. There could be lots of sites taking part in a trial both in the UK and around the world.
Research team are all the people involved in running a research study including consultants, doctors, research nurses, pharmacists and other health professionals, as well as the data managers and clinical trial coordinators.
Side effects are unwanted effects caused by the treatment. They can be mild like nausea or more serious. All side effects are carefully monitored and recorded so the researchers can assess their impact on the effectiveness of the trialled treatment. You must tell your research team if you experience any side effects, no matter how mild.
Sponsor is the organisation that has legal responsibility for the study and that oversees all the sites involved in the study. They could be a health organisation like Velindre, or a government body, charity, or industry organisation.
Standard of care is a term used to when your team talk about the best treatment currently available for your type of cancer. If you are in the control group of a clinical trial, you will usually receive the standard of care treatment – the same treatment you would have got if you had not joined the trial.