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We answer your questions about participating in a clinical trial for ovarian cancer. Find out more about how they work and how you can participate.

How do clinical trials work? 
What are the benefits of joining a clinical trial? 
How do I find out about clinical trials available for me? 
How do drugs get approved for use in the NHS? 

How do clinical trials work?

Clinical trials are research studies that test new medical treatments and procedures. Drugs and treatments are usually assessed in three phases before they can be considered as a ‘standard’ treatment option.

Phase I

This is the first time the treatment has been tested outside of the laboratory. Around 30 patients, or fewer, who have no standard treatment options available, are chosen to participate. 
 
The aim is to find a safe dose and look at possible side effects. If the treatment is safe and appears to have a positive effect, it will go into Phase II.

Phase II

Builds on the findings from Phase I, improving knowledge of potential side effects and on the best dose to give. 

It usually involves up to 100 people and looks at which type of cancer the treatment might work best for. If the tumours respond to treatment (either by slowing down growth or reducing the tumours), it moves to Phase III.

Phase III

This phase recruits the largest number of patients with hundreds or even thousands of people taking part, often from hospitals across the country. 
 
It compares the new treatment with a standard treatment and will look to see if the new treatment improves overall survival or progression free survival (how long patients stay free of cancer). Each clinical trial phase is designed to answer a specific set of questions about a new drug or treatment, which means there are strict guidelines about who can participate.

What are the benefits of joining a clinical trial?

Many women view taking part in a clinical trial as a very positive experience. Some of the benefits include:

  • getting a new treatment before it is widely available
  • being one of the first to benefit if the drug or treatment works
  • receiving additional monitoring and care – you will need to attend regular tests and check-ups
  • helping advance medical knowledge for the benefit of women now and in the future

rona-clinical-trials

Rona's story

“I would absolutely recommend women to take part in trials if they feel it is right for them. I was very keen to take part in it because I want to try and increase the different drugs that are available for use with ovarian cancer.”

Studies show that people benefit from taking part, whether or not they actually receive the trial drug. This could be because trials involve additional care and monitoring at the hospital. 

However, you also need to consider that new treatments are not always better than standard treatments; the new drug or treatment might not work for you; and sometimes there are unexpected side effects. 

As trials compare new treatments with standard treatments, you may be selected to receive either the new treatment or the standard treatment. So by agreeing to be in a trial, it does not necessarily mean you will receive the new drug being tested. 

How do I find out about clinical trials?

Speak to your oncologist, who will be able to tell you about the trials in your local hospital suitable for you. If there isn’t a trial, they may be able to give you information about trials in other hospitals. 

You can also find out about trials across the UK by visiting our Clinical Trials Information Centre.
As well as a helpful search tool, you’ll find information on:

  • how trials are designed
  • safety
  • useful questions to ask your oncologist

You may need to consider travelling to another hospital for treatment. 

Having discussed the possibilities for treatment with your oncologist, you may want to seek a second opinion, either at your current hospital, or one which is more involved in research and trials. Your CNS should be able to advise you on how to get a second opinion.

How do drugs get approved for use on the NHS?

A drug is given a license by the European Medicines Agency (EMA) or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK once it is deemed safe to use in a certain group of patients, and has shown to be of some benefit. 

Drug manufacturers generally submit applications for licenses once the results of clinical trials are published. This process can take up to a year.

Once a drug is licensed, the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium will, if asked, assess whether the drug should be used by the NHS. 

They look at the clinical and cost effectiveness of the drug. In other words, does the drug in question work better than standard treatments offered (either for all patients, or for a particular group of patients)? Is the price to the NHS acceptable for the amount of benefit seen?

This process can take some considerable time, and countries within the UK may reach different conclusions. 

This means it can take up to two years, or more, from results of trials being announced to the drugs being approved for use on the NHS.