CLINICAL RESEARCH TRIALS

Why is clinical research necessary?  To find out how to improve the management of cancer patients, new therapies need to be tested formally in the form of a clinical trial. In this way only new therapies that are better than the old ones are introduced into clinical practice.

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. 

Why enter a trial?

• You may have the opportunity to try new therapies. 
• 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 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. 
  

For information on ongoing trials - we have linked three reputable sites which will provide you with information on ongoing trials in Cambridge, the rest of the UK and across the world and Bedford Cancer Research Unit.