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.
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 of the clinical trial to make sure you have the best possible medical supervision whilst 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.
Yes! Every study will require some amount of blood and urine sampling. This is to ensure your liver and kidneys are functioning properly both before you take part, and during a study and sometimes to measure the medicine concentration in your blood to see how your body breaks it down.
Again, the answer is yes! Up to £120 per 24 hours you spend with us. 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 21 days after a follow-up visit.
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.
Yes! We require that all females of child bearing potential who take part in clinical trials are using at least two contraceptive methods from which one must be a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) 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.
It is important for volunteers attending an appointment to learn as much as possible about the clinical trial before deciding to take part. Read the Informed Consent Form in full before attending for your appointment. You will learn about the type of care that can be expected and the various procedures involved. You can discuss any issue or ask any question with the recruitment team over the phone, or with the research staff during your appointment.
All clinical trials must follow disciplined and practised procedures to ensure the utmost safety for all involved, that medicines are assessed in comparable conditions and that the highest quality data is obtained from the trial. This means that your meals, medication and clinical procedures may be subject of a specified timetable.
All our volunteers, visitors and staff are tested for COVID-19 each time they visit the unit using a lateral flow test. Only those with a negative test are granted access. We have also implemented a number of safety measures including mandatory wearing of masks and strict limitations to the number of people in the unit to ensure we can safely practice social distancing.
Screening for a study determines your suitability to take part but does not necessarily lead to automatic study inclusion. Study inclusion is something which is determined by a number of factors, which differ for each study. A member of the research team will talk you through these.
Admission for a study following successful screening indicates a high chance of being dosed but this is not absolute, as for every study a number of volunteers are selected to be reserves and do not go forward for dosing.
The administration of the study drug will vary from trial to trial. Medicine is most often administered in oral form, or on occasion intravenously via drip or injection. This information will be clearly provided to those considering enrolment onto each study.
This may be the first time that the trial medication (drug) has been administered to humans, so there may not be any direct knowledge of its side effect profile. However, the risks involved in all studies have been carefully assessed in animal studies, using doses that greatly exceed (on a dose per body weight basis) those that will be given to volunteers in a study.
The Medicines and Healthcare products Regulatory Agency (MHRA) closely scrutinise the protocol and safety of participants in all clinical trials. Every clinical trial must receive approval from MHRA before it can go ahead.
It is possible for any medication to cause side effects. You need to know and understand the side effects that could occur in any study before you agree to take part.
The purpose of clinical trials is to test a medication, whether it is new or a variation of existing products. The most important factor in clinical trials is the safety of participants. Secondary is the collection of high-quality data to show the efficacy of the medication.
This enables and informs decisions on further testing which is necessary until a decision can be made on the licensing, manufacture and distribution of the medicine being tested, or not if this is the case.
To fulfil these objectives, it is necessary for the application of strict and well-practised guidelines and procedures to maximise both safety and data collection.