FAQ

The trials conducted in our unit require that you are at least 18 years old, you’re registered with a GP and you do not have an allergy severe enough to require the use of an epi-pen. We run numerous healthy volunteer trials and we also conduct trials requiring volunteers from certain patient groups. If you are on medication, your eligibility will depend on what medication you are taking and the clinical trial design, which varies from trial to trial. For each clinical trial to provide the level of information needed to understand how a new medicine works, volunteers can only take part in one trial at a time; there is usually a ‘wash out’ period of 3 months between the end of one trial and the start of another. After that, you’re free to apply for another trial. If you have questions about your eligibility for a trial, please contact our recruitment team and they can discuss which clinical trials may be suitable for you.

Our studies can sometimes require one or more overnight stays at the research facility, and may require multiple outpatient visits. The number of visits depends on the requirements of each trial. When you stay at the research unit, you may have multiple blood draws, physical exams or vital sign checks for example. Between procedures, you may have time to read, study, watch TV, play games, etc.

Depending on the type of trial, there are certain conditions we may ask you to meet to ensure accurate results. These could include restrictions on exercise, smoking, medications and alcohol. We’ll give you full details before you apply to take part in a trial so you’ll always know what’s expected.

Taking part in our clinical trials is always voluntary. You are free to withdraw your consent at any time. If you decide to withdraw consent after receiving a dose of the trial drug our doctors may need you to come back for a visit to check that the drug is no longer in your system.

This is our opportunity to meet you, gather necessary information from you and perform basic screening tests; you will also have the opportunity to ask any question you may have to one of our doctors. You will be screened for each trial you wish to take part in as we need to make sure you are eligible on a trial by trial basis. On average, a screening appointment lasts 2 hours and a member of our recruitment team will advise you about the requirements for each trial when scheduling the appointment.

Here’s an example of what you can expect:

• We’ll take a copy of your photo ID as soon as you arrive
• Our medical team will explain the clinical trial and answer any questions you may have
• If you agree to take part, you’ll be asked to sign a consent form before any tests are done
• We’ll take a detailed medical and social history and verify these with your GP for safety
• We’ll take blood and urine samples
• We’ll perform a drug and alcohol breath test
• We will measure your blood pressure, pulse and record a heart trace
• Once we have your results, we’ll be in touch and inform you of the next steps.

Whilst you may not be suitable to take part in that particular clinical trial you can register with the consent 4 consent (C4C) database. This enables the recruitment team to contact you if we think you may be suitable for an alternative or future trial.

Not at all, we are like any other department within the hospital.

Our staff respects your privacy and follow the same data protection guidelines as the rest of the trust. No information will be given out about your participation and/or your medical information unless required by law. The sponsor, regulatory agencies, or an independent ethics committee may inspect your clinical research trial medical records which may include your name, address or other information that identifies you. If necessary, some or all of your records may be copied during these inspections. Because of this, absolute confidentiality cannot be guaranteed. The results of the clinical trial may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.

If you decide you wish to register your interest in clinical trials please complete the online enquiry form. Once submitted, a member of our friendly recruitment team will call you to discuss the trials currently available. They’ll ask you questions to check that you’re suitable for a trial, so we don’t waste your time. If you’re interested and suitable, the team will give you an appointment for a ‘screening’ visit. During your screening, you’ll have an interview with a doctor, who’ll explain the medical aspects of the trial in more detail.

Some of these costs may be reimbursed depending on the trial.

Whenever possible you will have a private room, however, some trials may require constant observation. If this is the case, you will share a room with other same sex participants.

This will depend on the trial; we don’t usually allow visitors during an inpatient trial stay due to volunteer confidentiality, however, some trials may specify visitors are permitted. Family and friends can be contacted at any point during your stay via the phone and internet.

Of course, any regular appointments with your GP or treatment team within the hospital should still be attended. We will write to your GP to inform them of your participation in any trial and it will also be made clear in your hospital case notes.

We reimburse volunteers for their time and inconvenience for the majority of the trials we conduct. Studies which are considered to give direct patient benefit by taking part don’t, however, we may be able to reimburse some of your expenses in these trials. The final sum varies from trial to trial and will be disclosed before you give consent to participate.

That depends on the trial you’re taking part in. Sometimes our trials can be conducted as out-patient appointments whilst others may involve overnight stays with follow-up visits to the unit.

Yes. It is very important to collect information or samples at set times. In order to do this, you’ll need to attend at the times and dates on the calendar given to you at screening. However, we’re aware many participants have outside commitments and adopt a flexible approach to appointments whenever possible. This is unique to each trial, so please discuss any commitments you may have with the recruitment and/or research team.

This depends on the trial you wish to take part in; each trial has its own list of inclusion and exclusion criteria that you will be provided with upon enquiry. It may be possible for you to continue taking all your regular medications and take part in a trial on our unit.

There are a number of online resources available. CISCRP.org: The Centre for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organisation dedicated to educating and informing the public, patients, medical/research communities, the media and policy makers about clinical research participation. The Over-volunteering Protection System: This UK database records when anyone participates in clinical research studies, including at the Royal Liverpool Hospital. This is required for scientific, medical and ethical reasons. Declaration of Helsinki: The Declaration of Helsinki, developed by the World Medical Association (WMA), is the ethical principles to which all human clinical studies must conform. Medicines and Healthcare products Regulatory Agency (MHRA): All clinical trials in the UK are approved by the MHRA. The website contains further information regarding their role in UK clinical trials. European Medicines Agency (EMA): The EMA provides policies and guidance documents on how clinical trials are conducted in Europe and the UK. National Research Ethics Services (NRES): A branch of the National Patient Safety Agency, which approves all clinical studies conducted in the UK.

If you are registered on Consent 4 Consent (C4C) we will contact you when we are opening a trial we think you may be eligible for. Alternatively, you’ll find more information by browsing our list of open trials; a brief summary of what the trial involves, the type of participants we’re looking for and the compensation you can expect to receive upon completion of a trial can be found here. Or if you prefer, call us. You can also find trial information on [insert links] Facebook and Twitter.

If you are interested in participating in a specific trial, any potential risks will be explained to you before you give your consent to participate. You will also be able to discuss any concerns you may have with a member of our medical team.

The medicines we trial are all tested thoroughly before we give them to volunteers. All our trials are reviewed by an independent ethics committee, who ensure that the information we give you is as complete as possible, and that our trials are ethical. A UK Government agency reviews them to make sure all trials are as safe as possible.