About Clinical Trials
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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.
- It will provide vital information on new therapies for future patients.
- Patients in trials are generally better supervised and have closer attention.
What happens if you are asked to enter a trial?
- You should be invited to enter the trial not told to
How to find a clinical trial?
Google remains a useful resource to search for news regarding clinical studies:-
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
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