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Clinical Trials |
Why are clinical trials necessary? To find out how to improve the management of cancer patients, new therapies need to be tested formally within the tight legal boundaries of a clinical trial. In this way only new therapies that are better than the old ones are introduced into clinical practice. Trials also ensure new treatments are safe and well tolerated. More recently they are also used to see if there subgroups of patients who would suit one treatment over another (e.g. related to their individual genetic profile). Finally trials are needed to assess whether new treatments are cost effective.
What types of clinical trials are there? Those involving drugs are split into 3 phases:-
Phase one - Testing a very new drug. Usually in specialised centres.
Trying to find out the correct dose and how it reacts in the body. All patients
in the trial are given the drug. Tumour response is not the primary end point of
the trial and the average chance of a tumour response would is less than 5%.
However, all new successful drugs have to go through this route so there is a
chance patients may have a greater response.
Phase two - Testing to see if there is a tumour effect. Once the
correct dose has been established in phase one studies. Careful assessment of
the side tumour response and side effects are conducted. All patient in the
trial are given the drug.
Phase Three - Once evidence of tumour response has been established in
phase two trials (and appears to be better than current therapies or have less
side effects) then phase three trials are started. These compare the new drug
with existing drugs or strategies. They are usually randomised. This means that
the patient will either get the existing therapy or the new therapy and at the
time of entering the trial the patient or doctor does not know which therapy
will be given. They may also include placebos (blinded medication)
Phase
Four - These are called post marketing studies. They usually involve product
which already have a license. They are either being compared against other licensed
drugs or are being investigated for further indications or a different aspect of
its use.
Why enter a trial?
- You may have the opportunity to try new therapies.What happens if you are asked to enter a trial?
- You should be invited to enter the trial not told to enter it.How to find a clinical trial
Google remains a useful resource to search for news regarding clinical studies:-
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Alternatively, there are a number of UK, European data bases of ongoing and completed clinical trials. The best examples are:
How to register a clinical trial
How to design and conduct a study
Useful tools:-
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