Most clinical research that involves the testing of a new drug follows an orderly series of steps, called 'phases'. The trials at each phase have a different purpose and help researchers answer different questions.
Phase I clinical trials involve testing new drugs, often for the first time, in a small group of patients and help doctors find out:
- If a new drug is safe
- If it has any side effects
- How much of the drug can be given safely, and how often
These trials may be offered to patients with advanced cancers; who have already exhausted other standard treatment options.
Phase I clinical trials also involve experimental drugs which target particular genetic faults within cancer and you may be asked if you wish to be tested for one of these genetic faults. If your cancer appears to have one of these faulty genes, you may then be invited to take part in an experimental therapy trial either before or after receiving standard therapies.
All Phase I clinical trials are carried out according to a strict set of rules (called a protocol), to ensure that they are safe for the people taking part and that they measure the right things in the right way. They go through robust checks, from Research Ethics Committees and other regulatory bodies (for example the Medicines and Healthcare Products Regulatory Agency - MHRA), as well as from The Christie's own Research and Development Department, before the clinical trial can begin.
Personalised Medicine at The Christie
A growing number of new treatments are now 'personalised' to an individual's cancer, moving away from the traditional "one size fits all" approach, as cancer is not an individual disease.
The most appropriate treatment is selected based on the unique molecular make-up of the patients own cancer. This is called personalised or precision medicine. If you would like to know more about the options available, please speak with a member of the team.
How do I take part in a Phase I Clinical Trial at The Christie?
You will need to speak with your own Oncologist about the treatment options available to you and he/she will refer you to us for further consultation if appropriate. Because of the strict criteria defined in the protocol, not all patients will be suitable to take part in a Phase I clinical trial and there may be other treatments or further trials that are more suitable. Your Oncologist will discuss this in more detail with you.
Once you have been referred to the Experimental Cancer Medicine Team, you will be invited to attend one of our clinics at the Christie Clinical Research Facility at The Christie Hospital. A member of the team will then explain in more detail what is involved in a Phase I clinical trial and may discuss a particular trial with you that they feel might be suitable.
Please be aware that only a small number of patients take part in Phase I trials and sometimes you may need to wait for a suitable trial