At the consent meeting, you will discuss the study with the research doctor and can ask any questions you may have about the study or the information you have been given. If you are happy to go ahead with the study, you will be asked to sign a consent form and the doctor will countersign it. You will be given a copy of the form to take away with you and keep.
Once you have consented to enter the study, we will start the screening investigations.
These are the tests that need to be conducted to assess how suitable you are to enter the study. This means we will need to perform blood tests to assess your organ function, scans (usually a CT scan but can be an MRI/PET or ultrasound scan), ECGs and any additional tests that are required for a particular study. For example, some studies require patients to have a heart scan (such as an echocardiogram), eye test or skin or tumour biopsy.
Once we have the results of these tests, we will contact you to confirm you are eligible to enter the trial and arrange for you to start treatment.
Treatment is given on the Early Phase Clinical Trials Unit which is located on level 1 of the Cancer Centre adjacent to the Oncology ward.
Some trial protocols require patients to stay overnight. You will be informed of these stays during the consenting process for the study.
If you are required to stay overnight you will be transferred to either the inpatient Oncology or Haematology Wards, depending on your diagnosis.
A placebo is a something that looks like a drug but that doesn’t contain any active ingredient. Placebos are used in clinical trials only where there is no standard treatment for a particular type of cancer. These trials aim to test whether the drug being studied is more effective than no treatment at all.
To make a fair comparison and reduce bias, patients receive, on a random basis, either the drug being tested or a placebo which looks the same as the drug. Usually neither the doctor carrying out the trial nor the patient knows whether the patient is taking a placebo or the active drug. In the term used in research, this is a ‘blinded trial’. At the end of the study, the trial is ‘unblinded’ and the patient (and the doctor) are informed whether or not they were using the active drug. If the patient becomes unwell during the trial, doctor and patient will be unblinded earlier if necessary.
Patients taking part in a clinical trial will always be informed if it may involve use of a placebo.
We assess the efficacy of study treatments by conducting regular scans (like CT or MRI scans) throughout the study to measure the size of your tumour. We compare these tumour measurements to the size of your tumour measured at the scan conducted at the start of the study (baseline). If your tumour has shrunk in size or if it has neither shrunk nor grown (stable) we invite you to continue taking the study drug and will continue to monitor your tumour with regular scans. Some treatments are given for a defined time period (6 months for example) and others allow patients to stay on treatment indefinitely until disease progression. This is stated in the information sheet given to you at the start of the study. If you are unclear how long you can remain on the study drug, the study team can tell you. If the study protocol allows you to stay on treatment indefinitely, you will continue to have regular scans and your tumour will be measured at each time. Provided your scans do not show significant tumour growth, or you do not display worsening symptoms or side effects, you can remain on study throughout. If you wish to stop treatment regardless of the scan results, you are welcome to do so as all our studies are voluntary.
If a scan conducted during the study shows that (compared to baseline) your cancer has significantly grown or your blood tests or symptoms suggest the study drug is not working, we will discontinue the study. This means we will stop giving you the study treatment. We will arrange at least one other appointment to reassess you after you have stopped the study and will refer you back to your main oncologist. If you are keen to try another clinical study, we will add your name to our trials waiting list and let you and your oncologist know if another study becomes available in the future.
Most trial drugs can cause unwanted reactions known as side effects. It is of high importance to report any side effect you may experience while on a trial. Please refer to the patient information sheet (PIS) for specific side effects of the trial drug/s.
We would like you to call us immediately on the number provided on the PIS or call 999 when advised to do so if you experience the following symptoms:
- Chest pain
- Difficulty breathing
- Generally unwell
- Shivering episodes or flu like symptoms
- Temperature above 37.5oc or a Temperature below 36oc
- Being sick (vomiting)
- Diarrhoea (4 or more times in 24hrs)
- Swollen or painful legs
- Sore mouth that makes eating and drinking difficult
- Bleeding or unusual bruising.
Call us on the EPCU numbers provided within 24hrs if you experience the following symptoms:
- Itching or painful skin changes/rash.
- Sore watery eyes
- Increase pain
- Nausea (feeling sick)
- Diarrhoea 2-4 loose stools/bowel movement in 24hrs
- Sore mouth, but able to eat and drink.
Please monitor the following symptoms and report if things get worse:
- Skin changes that isn’t itching or painful
- Mood changes
- Difficulty coping with the treatment; Loss of appetite.
These are a guide – with clinical trials there is always the possibility of coming across side effects which have not yet been seen, if you feel a change in yourself from normal, please contact us on the phone numbers provided:
We would like you to call us immediately on the number provided on the Patient Information Sheet (PIS) or call 999.
Randomisation is a way of preventing bias in research, and so helps make sure that the research results are valid. Patients taking part in the trial are chosen randomly by computer to take either the new drug or the standard treatment, with an equal chance of being chosen for either.
A phase 2 trial might use randomisation to compare two different ways of giving the same treatment. As an example, in a trial of a new tablet, after randomisation half the patients would be asked to swallow two tablets in the morning, the other half to take one tablet in the morning and one in the evening. Randomisation is also used in placebo-controlled trials.
The key standards that people who want to participate in a clinical study must meet.