About clinical trials
Research is essential if cancer treatments are to be developed, and healthcare is to be improved. Clinical Trials are one of the last stages of meticulous and careful research and is a scientifically controlled process for assessing potential new treatments. Clinical Trials are vital to prove beyond doubt the effectiveness of new treatments.
New cancer treatments are first tested in the laboratory and if it seems they may help to treat a particular cancer, they are tested in a clinical trial setting. Many trials compare new treatments against current standard treatments. Each clinical trial has a set eligibility criteria to ensure scientific validity and patient safety. This means that not all patients are eligible for trials. However, if a patient is thought to be eligible, they will be offered trial information including what the trial aims to achieve, what treatments etc are to be used and how, what procedures will be included, and how often they will be expected to attend the hospital. Patients will also have numerous opportunities to ask questions, and if they are happy to take part, they will then sign consent. Patients have no obligation to participate in trials and can be assured that their decision will not affect the standard of care they receive
If a patient does decide to take part in a clinical trial and signs consent, they will be monitored very closely. This can be done in numerous ways, including regular check ups at the hospital where they will be seen by their doctor and / or research nurse, blood tests and scans. It is also important to mention that before the hospital agrees to run a clinical trial, it is fully assessed by a UK ethics panel that determines the safety and that the research questions the trial seeks to answer is ethical.
The aim of the Clinical Trials Unit is to:
- Ensure access to varied high quality research for patients
- Present trial information for patients, relatives and NHS professionals
- Provide high quality care for patients involved in research
- Provide excellent research support to clinicians and cancer teams to facilitate research
- Co-ordinate national and international trials at Velindre Cancer Centre and other hospitals across South East Wales
- Collect accurate research information
- Maintain close links with national research organisations and pharmaceutical companies
- Promote cancer research across SE Wales
For a new treatment to be granted a UK drug license and used in the clinical setting, it has to go through each of the 4 phases and show to be safe and effective.
Phase 1 trials test a new cancer treatment or drug which has already been extensively tested the laboratory. It is the first time the treatment will be used to treat people and usually involve a small number of patients. It aims to find out:
- The safe dose range
- The side effects
- How the body copes with the drug
If the treatment is safe, it will then continue to the next phase and be tested in phase 2 trials.
Phase 2 trials include a larger group of patients and aims to find out:
- The effectiveness of the treatment on the cancer / symptoms
- the types of cancer it is most effective in
- more information about the side effects
- the best and safest dose to use
If the results are positive the treatment will proceed to a phase 3 trial
Phase 3 trials include hundreds of patients, and aim to:
- compare the effectiveness of newer treatments with that of standard treatments
- compare doses or ways of giving standard treatments
- determine how well the drug works and how long the effects last
- continues to collect information on side effects
Phase 4 trials are carried out after a drug is shown to be effective and has been granted a license, and aims to determine:
- how well the drug works when it’s used more widely than in clinical trials
- the long-term risks and benefits of the drug
- more about the possible rare side effects and safety of the drug
Our well established Clinical Trials Unit here at Velindre Cancer Centre has been running since 1994. Working with Cancer Clinicians, we participate in over 200 national and international clinical trials, and have specialist research teams to cover most cancer sites.
If you would like any further information, please contact the Clinical Trials Unit on 02920 316222.