What is a clinical trial?
A clinical trial is used to test new drug products and existing medications to help develop new treatments. At the Covance Clinical Research Unit in Leeds, we work with some of the world’s leading pharmaceutical and biotechnology companies on Phase I/II studies to test things like; how a drug is absorbed into the body, how a drug reacts to other medications and how the drug is affected by food.
Taking part in a clinical trial may involve collecting blood samples. If you don't like the thought of giving daily blood samples then perhaps this isn't for you.
Is it safe?
Is anything really safe? Crossing the road, driving a car, drinking too much? Clinical trials do carry some risk, however all measures have been taken to minimise them. We have a dedicated team of medical experts, including doctors and nurses, who are here to monitor your safety at all times. You’ll also be reassured to know that an independent Ethics Committee reviews each clinical trial to ensure all the right safeguards are in place before a study can start.
The Leeds clinic is extremely experienced and has been working in clinical trials for 25 years. Last year there were ~9,000 new medicines in development globally (Source: www.abpi.org.uk), of which ~1170 were Phase I stage, like those in our clinic. Assuming an average of 50 people take part in each trial this equates to ~60,000 people around the world taking part in studies in clinics like Leeds last year alone.
In 2011 we were the highest recruiting clinic in the UK so you can rely on us to take care of you.
What if I change my mind? That's no problem. Our medical trials are 100% voluntary, so if you have a change of heart after you've applied, at the screening session or even during the clinical trial you are free to do so. If you've already started the clinical trial our doctors may want you to come back for a visit, just to check that the drug is out of your system.
Are there any side effects?
Sometimes, but you'll always be made aware of the possible side effects before your study begins. Part of our Phase I clinical trials is to evaluate any side effects that a particular drug may cause and is nothing to worry about. Because we build up the dose of any drug slowly, we can monitor and manage any effects in a controlled way.
If you have any questions or concerns during your study, we're always here to help.
What do you test?
We test a range of potential new medicines and also updated versions of currently used medicines.
We work on behalf of Sponsor companies who have researched and developed a new medicine that is now ready for testing in people. The medicines can potentially treat any condition that people could suffer with, from acne or Alzheimer’s disease to yeast infections.
These companies will either want to test a brand new medicine that treat diseases in different ways to any available treatments, or they may have improved a previous treatment by making a medicine which they think will have fewer side effects or work better than the previous version.
As many medicines are tested in small amounts in healthy people first, you do not always need to have the condition to take part in the study. On the flip side, by taking a medicine for a potential condition, you will not be given the condition nor develop the disease as a result of taking part.
For example, some of our volunteers have been worried that if they are taking part in a study to develop a treatment for Hepatitis C, that they will get Hepatitis C. This is not true however if you are at all concerned, please get in touch with our friendly team who can provide further information.
Do you always trial new drugs?
No, we do test new medicines but we also perform studies with existing medicines.
Clinical Research Units, like Covance CRUs, can perform studies known as ‘first-in-human’ (FIH) trials. These clinical trials are used to test new medicines in people for the first time to look at the safety of a new medicine before it is given to any patients.
However, there are other medical trials that can be performed at our units. Lots of the studies we do are with medicines which have gone through this FIH testing process and have also been tested in patients. Once the medicine has been shown to be safe and effective in patients, there are lots of studies which need to be done to provide the information for how future patients will take the medicine. These are called ‘labelling trials’ as they provide the information on the medicine leaflet.
These clincal trials include looking at what happens to the levels of the medicine in your body if you eat a meal before taking the medicine or what happens if you are already taking another medicine as well, perhaps for a different condition. For women, studies also look at the effect on the contraceptive pill to see if taking the medicine will affect it working correctly. At this point the medicine has been tested in hundreds, if not thousands of people and so it is no longer considered a new drug in terms of clinical trials.
How long does a clinical trial last? This varies depending on the type of clincial trial. It can typically be anything from 2 nights to a month. For more details see our list of current studies.
Can I take part if I'm on medication?
This varies for each medical trial depending on what medication you are on and the trial design.
Each clinical trial has different requirements for the volunteers that take part. Most healthy volunteer trials require just that – healthy volunteers – and therefore if you are taking long term medication, you may not be suitable. Often if you are on short-term treatment, for example, a week of antibiotics for a throat infection, you would be able to take part once you have finished the course of medicine and the condition it was treating has cleared up.
However, research is also conducted in patient groups who may need to take medication more frequently to manage their condition. In this case it will depend on the trial requirements, but the trial will often be designed to allow patients to still take their normal medicines.
As this changes from trial to trial, please contact our recruitment team and they can discuss what clinical trials you may be suitable for.
Do I need to be registered with a doctor? Yes, you need to be registered with a doctor that holds at least the past three years of your medical history.
Do you inform my doctor of my participation in the study? Yes, we'll let your doctor know you're volunteering as part of our standard screening process. We simply need to check that there’s no medical reason why you can't take part in a clinical trial.
Will my details be kept confidential? We totally respect your right to privacy. No information will be given out about your participation and/or medical information with the exception of your doctor unless required by law. The trial results may be presented in meetings or publications, but you will never be personally identified.
How do I get detailed information on a clinical trial? You'll find more information on all our studies by clicking on browse current studies. As well as the medical trial names, dates and payment, there are details about what the study involves and what type of volunteers we’re looking for. Or if you prefer, give our volunteer recruitment team a call on 0800 591 570 or 0113 394 5200.
How are clinical trials regulated? All our studies are carried out under safety guidelines issued by the Royal College of Physicians. We also meet the standards set by the Medicines and Healthcare products Regulatory Agency (MHRA), the government department that controls clinical trials in the UK. All studies have to be approved by an ethics committee before any work is allowed to be carried out.
Where can I find independent information?
There are a number of online resources you can use. We have included a list of a few to get you started below:
The Centre for Information and Study on Clinical Research Participation
This non-profit organisation dedicated to educating and informing the public, patients and policymakers.
Clinical Trials Portal
Anyone from volunteers to research workers can use this website to find introductory information on clinical trials.
The Over-volunteering Protection System
This database is used in the UK to record when volunteers take part in clinical trials at any unit, not just Covance. This is required for a number of scientific, medical and ethical reasons, such as high volume of blood taken in a short period or potential for medicine interactions. These and many other reasons are detailed further on this site.
Declaration of Helsinki
The Declaration of Helsinki, developed by the World Medical Association (WMA), is the ethical principles to which all human clinical trials must confirm to. This information will help explain some of the procedures on a clinical trial, such as the informed consent process that takes place before any samples or tests are done.
Medicines and Healthcare products Regulatory Agency (MHRA)
All clinical trials in the UK are approved by the MHRA and their website contains further information regarding their role in UK clinical trials.
European Medicines Agency (EMA):
The EMA also provide advice on how to conduct clinical trials in Europe and the UK and their website holds information such as policies and guidance documents.
National Research Ethics Services (NRES)
The NRES are a branch of the National Patient Safety Agency and all studies conducted in the UK must have approval from NRES to start the trial. This is a great source of publications and information about ethical research.
National Institute of Health
This is an American website that details ongoing US trials, but provides some useful information
To understand what happens next with the study medicine after they have finished being tested in clinics like ours why not try: www.guardian.co.uk/helathcare-network-nihr-clinical-research-zone
If you want to look even further into the clinical trials industry, the following magazines may be of use:
Applied Clinical Trials Magazine: www.actmagazine.com/appliedclinicaltrials
Clinical Discovery Magazine: www.clinicaldiscovery.com