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Clinical trials are medical research studies where an intervention or treatment is offered to people to test how well it works compared to the current standard.
|What is a clinical trial?||Making a decision|
|What types of trials are there? The Phases||How to take part in a clinical trial|
|Pros and Cons||Where Can I Find a Clinical Trial?|
Clinical trials are medical research studies where an intervention or treatment is offered to people to test how well it works compared to the current standard. Trials are carried out because the benefit of a treatment or intervention is currently unknown. It may be better, the same, or sometimes not as good as standard treatments.
Clinical trials are the end of a long research process. Before a drug is ever tested on humans it will have been developed and tested in a laboratory. The trial will only take place if it is believed that there is likely to be some benefit for patients. Trials may show whether new approaches to prevention, screening, diagnosis or treatment work better or worse than those currently used, and whether they are safe or practical to use with patients.
Depending on how far through the testing process a drug is depends on the kind of trial you may be asked to take part in. Clinical trials usually have up to three phases, and information gathered in each phase helps researchers decide whether the study can move on to the next phase and the best way to do so. In phase one and two clinical trials, the intervention is received by everybody taking part (single armed trial). The third phase can involve comparing to existing treatment, a placebo (such as a sugar pill) or no treatment.
Phase one of a human clinical trial only takes place once a drug has been tested in a laboratory and researchers believe it may be beneficial. The aim of a phase one clinical trial is to introduce the drug to a small number of (normally healthy) volunteers for the first time. It looks to see how well the drug is tolerated, how it should be delivered (mouth, injection, etc) and what side effects occur.
Phase one trials help to decide on the correct dose, starting at a low dose, increasing and trying to find a balance between dose and side effects.
Phase two trials often involve larger groups of people (ideally 100-300) and aim to get a better understanding of the dose required for the treatment to be effective. The trial usually focuses on people with the disease, often hospital patients who can be closely monitored.
By monitoring how the drug needs to be given, how often and the side effects it is possible to begin to understand if it is a practical and acceptable alternative. It examines how well the intervention works, in the case of pancreatic cancer the effect on the tumour compared to any side effects. Results allow the final phase of the trial to be designed most effectively.
Phase three clinical trials involve the treatment or investigation being administered to many people, ideally in multiple locations. The intervention (or treatment) is given to one set of participants and a control group is used to compare to the current standard of care.
Participants are randomly assigned and where possible researchers do not know who is in which group (this is called a double-blind clinical trial and is the gold standard of medical research).
The analysis of this stage of the trial determines whether or not a treatment or intervention is effective in a practical form. At the end of the trial the results are analysed and published. At this stage it may be possible to continue the intervention (or treatment) you were on in the trial, however, not in all cases..
Changes to practise or your treatment being made available on the NHS following a trial may take years or never occur. An independent body, the National Institute for Health and Care Excellence, makes final recommendations on which treatments should be available based on cost as well as how well the treatment works.
It is important to know that there is no right or wrong decision when considering if you want to join a clinical trial. It may help to talk things through with your doctor or nurse, family and friends. Many people say that they would like to take part in a trial to benefit themselves or others, but the type of trial may be something that you want to consider
If you would like someone else to talk to about this, you can call the Macmillan Support Line on 0808 808 00 00 to talk to their cancer support specialists as well as your healthcare provider.
Do not be afraid to ask questions. The more you know about the specific clinical trial you would be in, and what it will involve, the better able you will be to decide if joining the trial will be right for you.
See our Clinical Trials FAQ section for guidance on some helpful questions to ask.
If you think that you would like to take part in a clinical trial, there are many places which hold databases of trials who are currently recruiting. Trials take place in different locations and are looking for different types of patients, so it is important that you find the right one to suit you. Cancer Research UK publishes lists of clinical trials and where they are taking place as does the UK clinical trials gateway. This is a database using information from researchers up and down the country and is a good place to start.
If you would like to take part in a trial, you need to discuss this with your doctor or cancer specialist. They are able to refer you for the trial or they may advise that the trial you have found is not right for you and help you find one that is. Bringing information about trials you are interested in to your appointments may help you explain your thoughts and open the conversation.
You should remember that a trial is being carried out because the benefit of the treatment is unknown (it may be better, the same or sometimes not as good as the standard treatment).
You can always ask your medical team if there is a pancreatic cancer clinical trial operating in your area that you may be eligible for. Applying for a trial does not automatically mean that you will be accepted. Trials often have specific patient groups that they are looking for and you may find as the process goes on that you are no longer eligible.
|UK||UK clinical trials gateway|
|Europe||EORTC Clinical Trials Database|
|International||World Health Organisation|
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|Information Product №||PCA0031v1||Published||15/10/2019|
|Last Updated||08/09/2022||Next Review Due||15/10/2022|