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‘Clinical trials are the ‘lifeblood’ of research in cancer medicine.
Without them there can be no progress,’ says neuro-oncologist Professor Roy Rampling. 'A clinical trial is a medical test or experiment on people including a new treatment or a new way of giving an existing treatment.
'Most often the treatment is a drug, but it could be a medical procedure or investigation. The treatment will have been tested on animals or in the lab with positive results, before getting to the clinical trial stage.'
Professor Rampling answers your questions:
A scientist develops a new idea either as a result of clinical experience or from laboratory experiments, for example: ‘If I give chemotherapy and radiotherapy together will patients have better outcomes than with radiotherapy alone?’
The scientist then writes a detailed plan for the trial (a protocol) and independent, experienced people have to like the idea (peer review) before it can be developed.
The idea also has to be approved by various other regulatory bodies, mainly to ensure the patients’ well-being is looked after. This process can take several years.
Clinical trials can cost millions of pounds. The scientists have to find money from government, or more usually, from specialist charities such as Brain Tumour UK and drug companies.
The overall aim is to find out if a new treatment or procedure is safe, helps patients feel better, has side effects or is better than existing treatments.
Clinical trials are often defined in four phases. Not all ideas have to complete all four but a new drug having to do so can take 10 – 12 years to come into general use.
Ask the doctors looking after you or look on the internet for trials in the UK and abroad. You can search for a clinical trial close to you on the brain tumour hub.
The new treatment may not be better and could even be worse than existing treatments. You may experience side effects that the doctors had not anticipated.
The treatment might work and you could be one of the first to receive it. You are likely to be monitored more closely than if you were not on the trial.
Every trial has entry criteria or conditions for taking part to ensure you’re fit enough and to increase the chance of the trial being successful. Criteria might include: type and stage of cancer, age, health and other treatments. If you do not fit the criteria your doctor can’t commit you to the trial.
You will meet the trial doctor so that you can be given all the information and can ask questions. Your partner, carer or someone else can go with you for support.
If you want to go ahead, you will have to sign a statement to say you understand what it means to take part in the trial. The process is called giving informed consent.
You can withdraw from a trial at any time without having to give a reason.
You will stay on the trial until one or more of these things happen:
No, patients have to be reimbursed for any out-of-pocket expenses they have as a result of taking part in the trial, eg. travel fees.
Version 1.1 January 2012 - Review date: January 2015
Clinical trials often generate many questions. If you have further enquiries please contact us and we will be back in touch.