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“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.”

Find out about ovarian cancer clinical trials – what they are, how they work and how you can find out more. 

What are clinical trials?

Clinical trials are research studies that investigate potential new drugs, new ways of giving treatments or different types of treatments and compare them to the current standard treatments.

How do clinical trials work?

Drugs and treatments are usually assessed in three phases before they can be considered as a standard treatment option. 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.

Phase I

The aim of a Phase I trial is to find a safe dose of the treatment and look at the possible side effects. If the treatment is safe it will go into Phase II to see if it has a positive effect on the patient.
 
In many cases, this will be the first time the treatment has been tested outside the laboratory. A small number of people - around 30 or fewer - who have no standard treatment options available, are chosen to participate. 

Phase II

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

It usually involves up to 100 people and looks at whether the treatment is having a positive effect on the type of cancer being studied. If tumours respond to the treatment (either by slowing down growth or reducing in size), it moves to Phase III.

Phase III

This phase recruits the largest number of participants 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 someone stays free of cancer). 

Phase IV

This happens after a license has been granted, and involves studies to monitor the medicine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain categories of people. 

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.

Often studies are randomised, so you will not know whether you are receiving the new or the standard treatment. Some research has shown that taking part in a trial improves long-term survival, even if you do not have the drug/procedure being tested. The reasons for this are not clear, however it has been suggested that hospitals which undertake medical research provide better treatment.

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?

You may be eligible to take part in a trial. They have strict criteria for joining them to make sure that the results can be relied upon by comparing like with like, and not all treatment centres are involved in trials. Your oncologist should know what is possible, but sometimes you may need to ask specifically about clinical trials. 

You might want to ask:

  • What trials are you eligible for at your treatment centre? 
  • If you’re willing and able to travel, what is available at another centre?
  • What is the aim of the trial? 
  • What is the evidence that this new treatment might be effective?
  • What are the possible risks and benefits of taking part?
  • What taking part would involve compared to not taking part?

You may also be asked to take part in research studies, for example into your wellbeing, which may involve taking part in interviews and surveys. 

Remember, if you are suitable, it is your decision whether or not to join a clinical trial. 

You can also find out about trials across the UK by visiting our Ovarian Cancer Clinical Trials Information Centre.

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 Clinical Nurse Specialist (CNS) should be able to advise you on how to get a second opinion.

Funding and access to drugs across the UK

The approval process for cancer drugs

Licensing

Once a cancer drug has completed clinical trials and there is evidence to show it is effective, it must be granted a licence before it can be widely used in the UK. A licence indicates all the proper checks have been carried out during its development and manufacture and the benefits of a medicine are believed to outweigh the risks. It must also demonstrate that it works for the purpose it is intended for it to be licensed. This licence is also known as a marketing authorisation.

In the UK, licences can be granted by:

  • the Medicines and Healthcare Products Regulatory Agency (MHRA) - which can grant licences for medicines only in the UK
  • the European Medicines Agency (EMA) - which can grant licences for medicines in the European Union (EU)

Funding

Once a drug is licensed it must be approved either by the National Institute for Health and Care Excellence (NICE) for use in England or the Scottish Medicines Consortium (SMC) for use in Scotland. Northern Ireland and Wales have processes in place for approving decisions made by NICE on new treatments and these are typically implemented in each nation.

In England, the manufacturer of the new treatment will apply to NICE for the drug to be approved for use by the NHS. This assessment is called a Technology Appraisal. As part of the assessment process NICE consults with stakeholders, including Target Ovarian Cancer, to ask them about the difference the new treatment would make. The SMC in Scotland follow a similar process. New treatments are assessed on the basis of how effective they are and how much they cost. 

Previously, cancer drugs in England could also be approved for use under the Cancer Drugs Fund (CDF). However, following reforms in 2016 the CDF has changed and now only provides interim funding for new cancer drugs until they are able to complete their full NICE approval. 

Standard drugs and treatment 

Most women with ovarian cancer will be offered standard treatments by their oncologist. This means drugs that are licensed for treating women with ovarian cancer in the UK and approved for use within the NHS on the grounds of clinical and cost effectiveness.

Read more about standard drugs and treatment for ovarian cancer for women recently diagnosed here, and for women if their cancer has come back here.

Non-standard drugs and treatments

Some women may wish to ask about other ways to access different drugs that have not yet been licensed to treat ovarian cancer or not approved for use on the NHS. Sometimes oncologists prescribe drugs to treat women with ovarian cancer (outside the clinical trial setting) that are not yet licensed for ovarian cancer if they believe she may benefit, for example, the drug may have been licensed for use in a different type of cancer. This is referred to as prescribing ‘off licence’ or ‘off-label’. Such drugs are not automatically funded on the NHS in any part of the UK.

An oncologist may also choose to prescribe a drug which is licensed but not yet approved for NHS funding. In either case the oncologist may well have to make a special application for funding for the drug which may or may not be accepted.

Occasionally manufacturers of the drugs in question will run a compassionate access scheme for patients who meet certain criteria, meaning the drug company meet the cost; however approaches to the drug company must be made by your oncologist.

It is important to note it can be quite stressful going through this process at a time when you are unwell. If your oncologist is reluctant or unsure about discussing other drugs, you can always ask for a second opinion. You will always need the support of an oncologist, as they have to make the applications for funding on your behalf.

 

The information on this page is approved by the Information Standard scheme to ensure that it provides accurate and high-quality information.

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Last reviewed: August 2017
Next review: July 2019