CLINICAL TRIALS

Clinical trials are specialised research studies which test different treatments and medicines, in order to help discover more effective ways of treating cancer, and also look at specific aspects of cancer treatment, such as reducing unwanted side effects from chemotherapy drugs. Currently around 18% of all UK cancer patients participate in clinical trials

What different types of trials are there?
There are five main types of trials:

Diagnosing trials examine new methods of testing, and new technologies so that cancer may be identified and diagnosed sooner.
Screening trials test new cancer screening methods, again to help lead to more cases being diagnosed earlier.
Prevention trials look at ways in which cancer may be prevented, and they may study aspects such as diet, exercise, smoking etc. Or they may study certain agents within the body, such as vitamins and minerals, and whether a person with high levels of a certain vitamin may be less likely to develop cancer.
Quality of life trials measure how a patient’s quality of life is affected by any given treatment.
Treatment trials look at new ways of treating a specific form of cancer, or specific symptoms more effectively.

Why are trials necessary?
Clinical trials prove the effectiveness of a particular medicine or therapy, and also the safety and risk of a particular treatment. Without clinical trials there would be no way to measure whether a treatment was likely to be successful or not.

Will participating in a trial give me access to better treatment?
Not necessarily. Clinical trials do not offer any guarantee of any better treatment, or that you will be able to access new medicines not currently in use within the NHS in the UK. While some trials may indeed be using new forms of medicine, others may involve experimenting with different ways of using existing treatments and technologies.

Why should I participate in a trial?
There are a number of reasons for participating. Of course, participation is dependent on a number of factors including availability and suitability – but your specialist will be able to advise on the best course of action for you. We also recommend that you discuss with your family and friends, and consider every point of view before committing.

Clinical trials offer the chance to contribute to current medical knowledge and research, to receive treatment from leading specialists in a particular field of cancer research, and to have your health closely monitored during the trial, so even the smallest change in your condition will be picked up.

Can I leave a trial after signing up?
Yes, you can leave the trial at any time, and you don’t have to give any reason should you change your mind. However any course of treatment that you receive during the trial would likely be discontinued after you left.

It is important that you familiarise yourself with every aspect of the trial before signing up, as you may be allocated to any particular aspect of the research. So if there is one particular treatment being offered within the trial that you would rather not receive, then it would probably be best not to sign up for that particular trial.

How are treatment trials structured?
Treatment trials are split into a series of phases to ensure they are safe, and that the treatments will work. All new cancer drugs are thoroughly tested in the lab before being administered for human doses.

Phase 1 – involves only a very small number of people, and aims to discover what the most appropriate human dose is.
Phase 2 – aims to discover which types of cancer the treatment will be used for. At this stage they may also try different methods of administering the treatment, and optimise the dose for effective treatment while reducing side effects.
Phase 3 – compares the new treatment against existing treatments to determine which is more effective. This often involves much bigger groups of patients from all over the UK, and even in other countries.
Phase 4 – usually looks at longer term risks and side effects. Normally this involves drugs and treatments which have already been granted a licence.

How will I be allocated?
Patients are allocated to a certain treatment pathway (arm) via randomisation. This means participants are selected at random by a computer in order to eliminate bias, and to ensure criteria such as age and gender are as similar as possible over different arms of the treatment. This also means each patient has an equal chance of receiving a new treatment, as well as receiving an existing treatment or a placebo (dummy) treatment.

What is a placebo treatment?
A trial may use a placebo (dummy treatment) when there is no comparative treatment available for that particular trial. If you were taking part in such a trial then it would not be made known to you whether the medicine contained any active ingredient or not. The selection for those who receive the medicine vs. those who receive the placebo would be done via randomisation.

What are the risks?
Clinical trials are strictly monitored and controlled, but may still carry some risks. These may include
– The new treatment may not be effective for you
– The treatment may be less effective than the standard treatment
– Unwanted side effects that have not been noticed previously
Your specialist will go over any risk for a particular trial, and you will have to weigh up all the pros and cons before deciding whether or not to proceed.
How do I get involved?
You may be invited to take part in a clinical trial, or if you wish you can request to take part in particular trials. To find out more, speak to your clinical nurse specialist.

What is informed consent?
Informed consent basically ensures that you are given all the information that you need, before making the decision whether to take part in a trial or not. Usually your consultant or research nurse will cover all the different aspects of the trial, which should include the following:
– The reason the trial is being conducted
– Why you may be a suitable participant for this particular trial
– What is involved in the trial
– Whether or not the trial is randomised
– The other treatment options available if you decide not to participate
– The benefits of taking part
– The possible risks and side-effects
– How long the trial will last
– How your treatment will be monitored during the trail

What happens next?
You will be asked to sign a consent form to show that you have read and understood all of the information relating to the trial. Please remember that participation is strictly voluntary, and you can leave the trial at any time. You should only agree to participate if you have fully understood and are happy with what is involved.
Usually during the trial you will be asked to complete questions relating to your health after receiving the treatment. This will help the researchers control any side effects, as well as monitor the effectiveness of the treatment being offered. In some trials the effects of the treatment will be monitored for months and even years after the trial has been completed, so you will have to agree to attend the hospital for any future appointments.

Where can I find the latest Clinical trials and will I be accepted on them?

 Below is a list if contact’s where most of the Clinical trials are available. All trials will have a list of eligibility and should you meet that criteria there is no reason why you cannot  be accepted on the trial.

Sarah Cannon Research Institute UK
If Living in the Greater London area we would recommend our friends at www.sarahcannonresearch.co.uk/ who have some of the worlds leading clinical trial specialist’s. They are based in London’s Harley Street and if you mention Bowel Cancer Support UK to them I am sure they will do there very best to help your every need. All of their Clinical Trial’s are on their website so please check the list of trials available before calling.

Alternatively all of the clinical trials can be found on the following websites, these include trials in NHS hospitals and clinics throughout the UK.

www.cancerresearchuk.org/cancer-help/trials/

www.ukctg.nihr.ac.uk/

And finally www.clinicaltrials.gov/ have a list of clinical trials world wide. We understand that a particular clinical trial suited for you may not always be available in the UK but we would always advise patients if considering a clinical trial  choose one close to home.