Frequently Asked Questions About Clinical Trials
Clinical trials play an important role as we help advance medicine. Get answers to your most common questions here.
About Clinical Trials
Before a drug can be prescribed, it must go through a long testing and approval process, including clinical studies. A clinical study is used to test new drugs (medications) and develop new uses for existing drugs. At our research clinics, we work with some of the world’s leading companies on studies to answer questions like:
- How is a drug absorbed into the body?
- How does one drug react to another drug?
- How is a drug affected by food?
The studies conducted at our clinics require that you are at least 18 years old. Medical eligibility requirements vary with each clinical study.
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 study at a time, usually with 3 months in between the end of one trial and the start of another. After that, you’re free to apply for another study.
If you are on medication, your eligibility will depend on what medication you are taking and the clinical study design, which varies from study to study.
If you have questions about your eligibility for a trial, please contact our recruitment team and they can discuss which clinical studies will work for you.
If you are interested in participating in a specific study 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.
There are plenty of urban myths about what happens on a clinical research study. These are just that: myths. Your safety is our number one priority. Drug development is highly regulated with strict safety and ethical guidelines and we take those regulations very seriously.
Participating in Clinical Trials
Yes. You’ll be paid for your time and participation during the clinical study. The payment you receive varies from study to study, depending on its length and type. You will receive a cheque at your last study visit on completion of the study.
Our studies usually require one or more overnight stays at the research clinic, and may require multiple outpatient visits. The number of visits depends on the requirements of each study.
When you stay at the research clinic, you will have multiple blood draws, physical exams and vital sign checks. Between procedures, you may have time to read, study, watch TV, play games, etc. Other recreational items such as a pool table, DVDs, board games and internet service are available.
Depending on the type of study, there are certain conditions we may ask you to meet to ensure accurate study 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 study so you’ll always know what’s expected.
Our clinical studies are always voluntary. You are free to withdraw your consent at any time. Once you’ve already started the clinical study, our doctors may need you to come back for a visit, just to check that the drug is out of your system.
You’ll receive between £15 and £100 per visit, depending on where you live, to help cover travel costs. There is limited parking available in the areas around the clinic. However, we advise that you use public transportation, such as the Leeds City Bus, which will drop you off outside the clinic. We will reimburse you up to £6 for parking. The closest car park is Woodhouse Car Park, LS2 3AX.
This is our opportunity to meet you, gather necessary information from you and perform basic screening tests. You will be screened for each study you wish to take part in as we need to make sure you are eligible on a study by study basis. On average a screening appointment last 2 hours. A member of our recruitment team will advise you about the requirements for each study.
Here’s what you can expect:
- We’ll take a copy of your photo ID as soon as you arrive
- Our medical team will explain the study 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
- 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.
There are many reasons why applicants don’t pass the screening stage. You can ask if it may be possible to reapply in the future or screen for a different study.
That depends on the study you're taking part in. Sometimes it's just an overnight stay with a number of follow-up visits to the clinic, but other times we may need you to stay longer to monitor the results of the medical trial.
A complete list of items you may and may not bring with you will be provided at the screening visit. You may bring personal care items and clean clothes sufficient for the period you will be required to stay at the clinic. Footwear is to be worn at all times when you are not in bed. You may bring:
- Comfortable clothing
- A personal cell phone, laptop computer or tablet
- A personal video game system
- Books and magazines
- Craft items
Covance will not be responsible for loss or theft of personal items.
You will share a room with other same sex participants.
In order to protect volunteer confidentiality we don't allow visitors during your time with us. However you are free to contact family and friends via the phone and internet.
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, when you’re not staying overnight, sometimes the visits can be flexible to fit in with other commitments you may have, such as work, errands or childcare. This is unique to each study, so please discuss any commitments you may have with the recruitment team.
Protecting Your Rights and Welfare
We only use licensed medical staff and physicians to conduct our clinical studies. An independent ethics committee reviews each study including all procedures. This review is conducted to make sure the study is scientifically and ethically sound.
This independent ethics committee oversees the processes that we use for informing you about clinical research studies, including the following:
- The purpose of the study
- What happens during the study
- Risks and benefits of study participation
- Background information on the drug itself
- Other studies involving the drug
Our staff respects your privacy. No information will be given out about your participation and/or your medical information unless required by law. For example, the sponsor, regulatory agencies, or an independent ethics committee may inspect your clinical research study medical records. This 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 study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.
There are a number of online resources available:
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 Covance. 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.
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