Trials and safety
We need approval from the MHRA and a Research Ethics Committee (REC), an organisation independent from pharmaceutical companies and us. The MHRA checks that there is the necessary information available to do the trial, and that the study is safe and well designed. The REC considers the safety, health and ethical implications of doing the trial in the chosen participants.
At HMR, we do trials in healthy volunteers only when our experienced doctors decide if it’s safe to do them. For new medicines, we don’t know all its side effects. We give volunteers an information and consent form (ICF) in advance. The ICF is approved by the REC and it contains the information you need, to decide whether to take part or not, including expected side effects. So, you have plenty of time to read and decide what to do. We have members of staff and doctors in the unit 24/7 available to look after volunteers.
For both over-the-counter medicines and study medicines, some people will experience side effects. For example, some medicines to treat cold and flu symptoms may cause drowsiness. These side effects are usually minor and wear off without causing any harm. Serious side effects are extremely rare, as the study medicine is usually given in much smaller doses than have been shown to be safe in animals. The REC ensures that our consent form for subjects includes all the important information about any known side effects. Remember, there will always be a doctor available, and medical staff to advise volunteers about any side effects.
Different drugs are removed from the body at different rates. But most drugs are undetectable in the blood by 3 months after the last dose – that’s one of the reasons why we ask volunteers to leave a 3-month gap between studies.
The number of participants varies depending on the trial, usually about 8 – 24. The number of volunteers who will be given a definite place on the trial is stated on the information sheet for the trial, so please check.
A ‘definite place’ on a trial means that you’ve passed screening and you have a place on the trial. If you pass all of the admission tests when you come for your first stay on the ward, you’ll do the trial. If you don’t pass the tests, we’ll ask a reserve volunteer to take your place.
If you’re a reserve volunteer, we’ll admit you to the ward as if you were going to take part in the study. You must be willing and able to take part in the whole study, so make arrangements to do so – for example, bring enough clothes and book enough annual leave for the whole study session. But we may not know whether we can give you a definite place until all the study participants have taken the study medicines. You can leave the ward as soon as we know we can’t give you a place.
If you’re a reserve on more than one occasion, we’ll do the above procedures, and the procedures before dosing on Day 1, each time we admit you to the ward. If we do offer you a definite place, we’ll reduce your payment if you refuse it.
If you choose not to participate there is no penalty or loss of benefits to which you are otherwise entitled; you won’t suffer in any way. If you do take part, you need to know the following.
You can withdraw at any time without giving a reason and without penalty, although you may not be paid in full. If you withdraw, we’ll stop collecting information about you, and you can ask us to destroy any of your samples (such as blood and urine). But we’ll keep any information that we’ve already collected. We’ll ask for your consent to follow you up to make sure you’ve come to no harm as a result of taking part in the study. We’d do all the tests planned for the final discharge day. If you drop out of studies repeatedly, we may not allow you to take part in future studies at HMR.
If you participate in a trial, you’ll have to wait for 3 months before you can participate in another one (usually from the last dose of study medicine). However, sometimes the study medicine or its effects last longer than 3 months, so there are many outpatient visits scheduled for several months after your last dose of study medicine. If your outpatient visits are scheduled over more than 3 months, you can’t take part in the next trial until you complete the last follow-up visit for the current trial.
Who can take part?
You can take part in most of our trials if your weekly alcohol intake is less than 21 units if you’re a man and 14 units if you’re a woman. However, if you drink too much, you may not pass the screening blood tests. We recommend that you try to drink less, don’t drink too much, it isn’t good for you!!
Eligibility criteria depend on the trial. We often have trials for just non-smokers, but sometimes for smokers and non-smokers.
Trials for smokers have restrictions such as ‘only up to 10 cigarettes per day’ and you cannot smoke while you’re at the unit.
Caffeine, alcohol and substances in grapefruits may affect your body. For example, alcohol, like medicines, is broken down in the liver, and can affect blood tests. If you drink alcohol while you’re on a trial, we won’t know whether it’s alcohol or medicine affecting your results. So, you need to follow the study restrictions.
It is important for us to check how much study medicine is in your blood and how long it takes to get rid of it. Therefore, it’s rare that we don’t take your blood at all. The number of blood samples depend on the trial, but we use a cannula (like the tube used to inject medicines into a vein) so, we won’t use a needle every time we take blood from you. Sometimes, we might need to take your blood in the middle of the night.
If you’ve been hospitalised before, you might have seen one. It’s a plastic tube similar to the one that’s used to inject medicines into a vein in hospitals. You use it when we have many blood samples on a day so that we won’t need to take as many blood samples with a needle. One of our experienced doctors will put it in one of your arms, after local anaesthetic so you don’t feel pain.
You’ll come back to HMR usually between a few days and a week after your discharge after your last dose of study medicine. The procedures for the follow up visit are similar to what you did at screening. If you have no problem with your follow-up results, that’s it and you’ve completed your trial!
You may need to come back to HMR after the follow-up visit if you need a repeat test. Because of this, we recruit people who’ll stay in the UK for at least 2 weeks after the planned follow-up visit.
During your stay
We have 3 wards (A, B and C) across 3 floors. You’ll be allocated to stay on one of them, depending on the trial. The wards are like a big open hospital room. We don’t have separate rooms for men and women. You can check the details from ‘our facility’. Each bed has a curtain so you can maintain your privacy.
You have to bring your own towels and toiletries, so please bring anything you think you need for staying on the ward. We have books, magazines, comics and DVDs but you can also bring your own entertainment. A short trial can be very busy, but for longer trials you’ll probably have plenty of free time. So, please think in advance how to use your free time.
We have lockers for your valuable items. We won’t be responsible for your belongings so we’d recommend you to use them.
We can take you for a walk during the stay on the ward, if you’re on a long trial. But usually, you’ll stay on the ward without leaving, until you’re discharged. That’s because we document any events that occur while you’re on the ward. Also, we’d like all volunteers to have the same environment and to be safe.
We’re sorry, but you can’t have any visitors (not even family) for security reasons, as well as for the privacy for other participants.
Yes, you can. you can use our WIFI for free.
We provide HMR standard meals. We can also provide vegetarian meals, depending on the trial. However, you cannot bring any food with you.
We won’t give you schedule in writing, to avoid confusion with documents. You can check what’s happening on a given day by checking the information sheet. Your schedule is set in advance so, if you want to know what’s happening on a particular day, please feel free to ask a member of our staff, who’ll give you details of your schedule for that day.
If you stay on the ward longer than a week, we offer laundry service. However, please note that we’ll launder all the clothes for a group together.
Your study payment includes all your travel expenses. We won’t pay any extra travel expenses unless we’ve specifically agreed that with you.
Payment is according to the length of the trial. It doesn’t change according to the type of study medicine. Payment is for your time and inconvenience and is never a reward for risk. It’s a ‘thank-you’ for seeing the clinical trial though to its completion.
We try to encourage bank transfer for study payments, as they’re the quickest and safest way for you to get your payment. But if you make it clear that you’d like to be paid by cheque, then we’ll do that.
We’ll pay you about 2 weeks after we discharge you from your final session, if your results show that you don’t need any more tests. If you still need more tests at 2 weeks after your final session, we’ll pay you half your study payment then. We’ll ask you to come back for repeat tests. You won’t get the rest of your study payment until the doctor decides that you don’t need any more tests. Wherever possible, we’ll pay you by electronic transfer into your bank account. If we can’t do that, we’ll write a cheque in your name, and mail it to the address you give us. We won’t make any other arrangements for payment.
We’ll keep information about you, such as your name, address, photograph and medical details, in paper form and on computers. We’ll keep the information for at least 15 years. We won’t give your name, address or photograph to anyone outside HMR, except your GP, or hospital staff. But people who work for the sponsor may see our records of your name, address, photograph and medical details, including information about ‘sensitive’ things such as your health, race or sex life.
We’ll give a code to any samples (such as blood or urine), and information about you, that we send outside HMR (apart from any we send to your GP, or hospital staff), so that people won’t know they come from you. We’ll do the same if we write a study report or present the results at meetings outside HMR or in medical journals.