What are clinical trials?

All new treatments have to be thoroughly tested. Researchers test possible new drugs in a laboratory to begin with. If they look promising, they are carefully tested in people.

• Risks and causes – how genetics, lifestyle and other factors can increase people's risk of cancer.
• Preventing cancer – using treatment or lifestyle changes to reduce risk.
• Screening – tests for the general population or people with higher than average risk of cancer before they have symptoms.
• Diagnosing cancer – new tests, scans or procedures to improve diagnosis and pick up cancer earlier.
• Treatments – new treatments such as cancer drugs, radiotherapy or surgery. Trials also look at different doses or combinations of treatment. 
• Controlling symptoms or side effects – new drugs or complementary therapies might help with this.
• Support and information - for people with cancer and their carers, families or friends

Read the full video transcript.

Trials are a part of routine cancer care. Taking part can involve different things. For example:

• trying a new medicine or treatment
• giving samples, such as  blood or tissue
• filling in a questionnaire
• having a scan

You might have just one appointment, or you could be part of a trial for a few years.

Why do we do clinical trials?

Clinical trials are important for learning more about cancer. They help us find out what causes cancer, how to prevent it, treat it, and how to diagnose it earlier. Trials also create new treatments with fewer side effects and improve life for people with cancer.

Many trials involve a new treatment or explore using an existing cancer treatment in a new way. These trials aim to find out if a new treatment:

• is safe
• has side effects
• works better than the current test or treatment
• affects quality of life 

What trials tell us

Some trials will show that a new treatment works better than an existing treatment. Others will tell us more about the side effects, or what happens to a drug in the body.

• the treatment being tested does not work or
• that it has side effects that are worse than with existing treatments. 

It all adds to our knowledge of cancer and how best to treat it.

Are trials safe? 

Your safety is a very important part of all clinical trials. You are closely monitored by a team of doctors and nurses who are experienced in research. They follow strict rules and guidelines to protect you. But there are some risks with any clinical trial. The possible risks and benefits will be clearly explained to you. 

If you have any concerns or problems, always talk to your research team. We have more information about safety in clinical trials.

The research team 

A research team includes many specialists who work together to make sure the trial is safe and runs smoothly. All team members are trained in clinical research.

The team might include:    

• research nurses – your main point of contact during the trial
• the principal investigator (PI) – the doctor in charge of the trial
• research doctors – these might be consultants, registrars, and fellows
• research coordinators and officers – they help organise and run the trial
• laboratory staff – they look at blood and other samples
• data managers – who collect and record trial information and results
• clinical trial administrators – they support the running of the trial
• research pharmacists – they prepare and manage trial medicines

The team may vary depending on the hospital or research centre. Some team members do research alongside their regular jobs. You’re most likely to meet research nurses and doctors during the trial.

Where you see the research team
If you join an early phase trial, your treatments and tests might take place in a special trial unit where you see the team regularly. 

For late phase trials, you may have your treatment on a ward, or a day unit. So you will probably talk to the research team less often.

Your research team will give you contact details so you can contact them with questions or concerns about the trial.
 

References

Oxford Handbook of Clinical and Healthcare Research (1st edition)
R Sumantra, S Fitzpatrick, R Golubic and others
Oxford University Press, 2016

ECMC: Successful nursing in a Phase 1 environment
P Cambell and others, 2019
 

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