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.

Why enter a drug trial?

What happens if you are asked to enter a trial?

- You should be invited to enter the trial not told to enter it.
- You should be given a full verbal and written explanation by a member of the Oncology Team.
- If you agree to participate in the study you will be asked to sign a consent form.
- Agreeing to enter this study does not change in any way the treatment you will receive connected to your disease.
- You will be asked if we can inform your GP that you have entered this study.
-You have the right to withdraw form the study at any stage. 
- Although your doctor will consider the medication you received in the trial it does not effect your right for subsequent treatment. 

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:

• The National Cancer Institute Clinical trials register  - International  
• USA Government Clinical Trials Register - US and international
• National Research Register Register of studies involving the UK-NHS
• International Federation Pharmaceutical Manufacturers - register of ongoing studies conducted by the pharmaceutical industry. - Pharma trials
• Clinical trials at Addenbrooke's - Cambridge
• Clinical trials at the Primrose research Unit Bedford -Bedford

How to register a clinical trial

• European Clinical Trials Database -  EudraCT
• UK National Cancer Research Network - NCRN
• International Standard randomised Controlled trial Number Register -  ISRCTN

How to design and conduct a study

Useful tools:-

• Understanding clinical trials document to download
• Trials tool kit
• Patient information advisory body
• Patient safety advice
• Public guardian advice 
• Advice on public involvement
• Share experiences forum
• Human tissue Authority
• Patient confidentiality
• Consent .

Essential legislative bodies:

• EUdirective
• UK ethic (NRES)
• MHRA

Useful organisations: 

• EORTC
• MRC
• NCRI
• World Medical  Association