Clinical Trials

As a bladder cancer patient, you might be asked by your doctor whether you wish to take part in a particular clinical trial.   Or you might want to find out yourself what trials are available and may be appropriate.

Clinical trials are vital to develop new and better treatments.  For patients, they can be a way of accessing a new treatment before it becomes generally available.  There are many types of clinical trial designed to test a medicinal product (a drug), a procedure, a device or another type of therapeutic intervention.

How Clinical Trials Work describes a typical process for a drug based clinical trial, although the process is similar for all types of clinical trial.

New treatments will typically be developed within a research laboratory and at that stage they are experimental and are not available for use in patients.  Experimental treatments will also be tested within the laboratory before they are submitted to clinical trial.

Not all patients will be suitable for a clinical trial. Some trials can also only be run in certain hospitals either because of their complexity or because of the particular type of treatment.

Finding a Clinical Trial

If you want to join a trial, you will usually need to be referred by your doctor, so the best place to start is by asking your specialist.   They will know from your records whether you might be suitable and will be able to direct you to any locally based trials, or know about larger national studies.   You could also search for a potential trial and take the details to discuss at your next appointment.   If you are suitable for a particular clinical trial and are willing to travel to the hospital where it is available, your specialist can potentially refer you for this.

You can see some of the current bladder cancer trials on our list. 

Please do let us know on if you are aware of any other current trials which could be included.

How Clinical Trials work

Clinical Trials are carried out in stages or phases - most often phases 1 to 3 (sometimes written I, II and III), although occasionally there is an earlier phase 0 or a later phase 4.  Phase 1 is usually the earliest trials in patients.  These phases cover issues from what side effects a drug might cause through to testing whether a new drug is better than an existing treatment.

Phase 0

This phase looks at whether a drug behaves in the way researchers expect it to from their laboratory testing and will usually only involve testing in a small number of people.  The dose of the drug used will be too small to treat your cancer, however because the dose is small you would also be less likely to experience side effects.  The tests would look at things like how the drug affects the body, and how cancer cells in the body respond.

Phase 1

These trials will usually only involve a small number of patients. These patients will often have advanced cancer and have already had other treatments which are available for them. After a treatment has been tested in the laboratory, a phase 1 trial would be done to look at things like: the safe dose of a drug, the side effects and how the body copes with the drug, and whether the drug will affect the cancer.  This testing has to be done first before moving to the phases of the trial which test the effectiveness of the drug in treating the cancer.  Phase 1 trials can take a long time to complete even though a small number of patients are involved.   The trial will work with small groups of patients increasing the dose of the drug slightly with each group, providing the results go well - called a dose escalation study.   The results of these studies will indicate the best dose for this particular drug.  A patient participating in a phase 1 trial will be monitored closely to see how the drug is affecting you and how your body is coping and any side effects.  Patients in a phase 1 trial may benefit from the new treatment, but others won't.

Phase 2

Not all treatments will progress to a phase 2 trial.  These trials might be for people with the same type of cancer or who have different types of cancer. These trials are larger with perhaps around 100 patients taking part.  A phase 2 trial might compare an existing treatment with the new treatment or with a placebo.  It will move into a phase 3 trial if it proves to be as good as or better than an existing treatment.   Some phase 2 trials might be a randomised trial, where participants are put into groups at random.  One group receives the new treatment being trialled, while the other receives the current, standard treatment eg by giving a placebo (or dummy drug).  This is so that the effects of the new treatment can be isolated from other factors. Phase 2 trials will look at: which types of cancer the treatment works best for, further studies of the best dosage and side effects and how they might be managed, and whether the treatment works well enough to go to a larger phase 3 trial. 

Phase 3

These trials will compare the new treatment with the existing standard treatment (that is, the best treatment which is currently available) and might compare a new treatment with the standard treatment or giving a standard treatment in a new way or in different doses. These trials are usually much larger than phases 1 or 2 and might involve thousands of patients in hospitals across the UK and even abroad.   Success rates or percentage changes may be small, so a much larger trial group is needed to show these differences accurately.   Most phase 3 trials are randomised trials.

Phase 4

A new treatment may have a Phase 4 trial which will be done after a drug has successfully progressed through a phase 3 and has been given a licence for use.  This trial could study: any long terms risks or benefits, further study on side effects and safety, and the effectiveness when it is used widely.

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