What do I have to do?
Healthy volunteers are given the new medicine as part of the clinical trial. The clinical trial is to test:
- How long it takes for your body to absorb and then get rid of the medicine.
- How the medicine interacts with food and other medication.
- How much can be taken without any undesirable side effects.
Once you have taken the study medication, blood samples are collected for analysis. Other tests may be performed such as blood pressure, temperature and heart rate measurements. These tests determine what effect the medication is having on your body. Your health is very important and you will be monitored very closely. Your full co-operation is essential for safety reasons and to ensure accurate results.
Do I have to stay in the unit during a study?
The answer is usually yes! The commitments of a particular trial will be explained to you before you are asked to give written consent to participate. Normally, we require all volunteers to stay in the Unit for the duration to make sure you have the best possible medical supervision while taking part. Sometimes we will ask you to refrain from smoking or drinking alcohol for example, and by asking you to remain in the unit we can make sure these requirements are complied with.
Will I be paid for taking part?
Again, the answer is yes! Up to £100 per day. The payment is proportional to the time you spend on a study, so for example, you will be paid a lot more if you take part in a 2-week study with lots of extra visits than if you take part in a single overnight study. This will be paid to you by cheque once you have undergone a follow-up visit usually 1–2 weeks after the study.
Will I have to give blood during the study?
Yes! Every study will require some amount of blood (and urine!) sampling. This is to ensure your liver & kidneys are functioning properly both before you take part, and during a study and sometimes to measure the drug concentration in your blood to see how your body breaks it down.
Can I take part if I am on medications from my doctor?
Usually, the answer would be no. Because in Phase I research we are looking at the actions of research medicines, we may not know what would happen to your body (medicine interactions), or how your body responds to the research medicine if you have any underlying condition. Besides, it would not be ethical of us to ask you stop taking medications you need in order to take part.
I’m female and take the contraceptive pill, can I take part?
Yes! We require that all females who take part in clinical trials are using some form of contraception throughout the duration. This may be the pill, implantable/injectable contraceptives, or documented sterilisation. We will also test you for pregnancy before and during a trial.
