A clinical trial is a research method that compares the effects of one treatment with another. The subjects of a clinical trial can be patients, healthy people, or both.
If you are interested to take part in a clinical trial, you can ask your doctor or a patient organisation if they know of any clinical trials that you may be eligible to join. Other ways of finding out including registering your interest in taking part in research online.
The UK Clinical Trials Gateway (UKCTG) website searches through different registers and pulls through information about clinical trials and other research from several different UK registers. When you sign up to it, researchers will get in touch about research that might be suitable for you.
While this is the main method of contact, you can also search the UKCTG site to find trials relevant to you, and you can contact researchers yourself.
If you are looking for something on a global basis, the World Health Organization’s Clinical Trials Search Portal provides access to clinical trials in countries all around the world.
Charities can also be a good source of clinical trials.
Some charities which look for people to take part in clinical trials include:
- Arthritis Research UK: current clinical trials and studies
- Cancer Research UK: find a clinical trial
- Multiple Sclerosis Society: MS clinical trials
- Target Ovarian Cancer: clinical trials information centre
- Parkinson’s UK: clinical research
Why would anyone consider being a human guinea pig? If we are brutally honest, that is what it amounts to. And if we were being very honest, we might fine-tune it down to two reasons: treatment and financial incentives.
Clinical trials help doctors to understand about how they can treat a particular disease or condition. It may benefit you, or others like you, in the future. And if you participate in a clinical trial, you may be one of the first people to benefit from a new treatment. However, you must be prepared that the new treatment may turn out to be no better, or worse, than the standard treatment, and that your participation is the method through which they find out. However, you may be placed in the control group, which means you not receive any treatment, but others who do have their results compared to you – and that can be very disappointing.
Some clinical trials offer payment, which can vary from hundreds to thousands of pounds depending on what is involved and expected from you. The majority of trials however are unlikely to offer payment beyond your travel expenses.
Before you sign up to a trial, it is important to find out about the inconvenience and risks involved and to carefully weigh up whether it is worth it. You have to remember that trials can be time consuming – you may be expected to attend a number of screening and follow-up sessions, and some trials require you to stay overnight. In addition to the constraints placed on your time, there may be restrictions on what you can and cannot do – for example, you may be asked to not eat or drink alcohol for a period of time. As trials are essentially the assessment of treatment in their experimental stages, you may experience unknown side effects from the treatment.
All clinical trials of new medicines go through three or four phases to test whether they are safe and whether they work. The medicines will usually be tested against another treatment called a control and the results compared to note any significant effect. The control will either be a dummy treatment (a placebo) or a standard treatment already in use.
The first phase of the trials involves a small number of people, who may be healthy volunteers, are they are given the medicine. In this phase, the drug is being trialled in human volunteers for the first time and the purpose is for the researchers to test for side effects and calculate what the right dose might be to use in treatment. Unfortunately if the doseage is too high side effects can be uncomfortable. Researchers start with small doses and only increase the dose if the volunteers don’t experience any side effects, or if they only experience minor side effects. Sometimes the threshold to which side effects occur is sought – not nice!
In the second phase, the new medicine is tested on a larger group of people who are ill. After having passed the side effects filter, this stage is to get a better idea of its effects in the short term.
The third phase involves medicines that have passed phases one and two. These medicines are tested in larger groups of people who are ill, and then they are compared against an existing treatment or a placebo to compare the benefits or side effects. Often after this stage the treatment is examined for its cost-effectiveness as well.
Some medicines undergo a fourth trial phase while they have been passed for use. The safety, side effects and effectiveness of the medicine continue to be studied while it is being used in practice. However, this is not required for every medicine. It is only carried out on medicines that have passed all the previous stages and have been given marketing licences – a licence means the medicine can be made available on prescription. You can find out about the whole process here in greater detail.
You cannot choose which group you are put in when you are accepted for a clinical trial. You will usually be randomly assigned to either the treatment group – where you’ll be given the treatment being assessed, or the control group – where you’ll be given an existing standard treatment, or a placebo if no proven standard treatment exists.
And while the treatments are different in the two groups, researchers try to keep as many of the other conditions the same as possible, so that the effect of the treatment can be fully quantified. The conditions may extend to the trial groups. For example, both groups should have people of a similar age, with a similar proportion of men and women, who are in similar overall health. In most trials, a computer will be used to randomly decide which group each patient will be allocated to, in order to avoid human bias in selection. In many trials, nobody knows who’s been allocated to receive which treatment. This is known as blinding, and it helps reduce the effects of bias when comparing the outcomes of the treatments.
If you do express interest in a trial, a doctor or nurse is likely to tell you something about it in person before you undergo it. You’ll also be given some printed literature to take away, and if you have concerns over the trial you may come back with some questions you feel haven’t been answered.
Some questions you may ask may include:
What is the aim of the trial and how will it help people?
Who is funding the trial?
What treatment will I get if I do not take part in the trial?
How long is the trial expected to last, and how long will I have to take part?
How long will it be before the results of the trial are known?
What will happen if I stop the trial treatment or leave the trial before it ends?
What would happen if something went wrong? It’s rare for patients to be harmed by trial treatments, but you may want to ask about compensation if this were to happen.
How much of my time will be needed?
Will I need to take time off work?
Will I be paid?
Will the costs of my travel to take part in the trial be covered?
If the trial is testing a new drug, will I have to collect it from the hospital, will it be sent to me by post, or will I get it through my doctor?
Will I have to complete questionnaires or keep a diary?
What are the possible side effects of my treatment?
How could the treatments affect me physically and emotionally?
Who can I contact if I have a problem?
Will someone be available 24 hours a day?
How do I find out the results of the trial?
There are many questions you may have and it is best to feel fully secure before you undergo a trial. As in the case with any treatment, you can’t be sure of the outcome. And if you are part of the treatment group, you may be given a new treatment that turns out not to be as effective as the standard treatment. As with all medicines, it’s possible you’ll experience unexpected side effects. And while it is rare, you must be prepared that you may leave the trial in a slightly poorer state of health than when you entered it! You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment isn’t helping you. Your departure can be at any point without giving a reason and without it affecting the care you receive.
A good thing to also bear in mind about trials, too, is that you may have to visit your place of treatment more often, or have more tests, treatments or monitoring, than you would if you were receiving the standard treatment in usual care.
At the end of the trial, the results are published by the researchers and are then made available to anyone who took part and wanted to know the results. If the researchers neglect to offer you the results and you want to know, you are well within your right to ask for them. Bigger agencies such as the National Institute for Health Research (NIHR), have websites where they publish the results of the research they have supported.
Trials are regulated and judged ethical by the MHRA. Before a clinical trial of a new medicine can begin, a government agency called the Medicines and Healthcare products Regulatory Agency (MHRA) needs to review and authorise it. One of the functions the MHRA performs is in inspecting sites where trials take place to make sure they’re conducted in line with good clinical practice.
Another body, the Health Research Authority (HRA) works to protect and promote the interests of patients and the public in health research. It is responsible for research ethics committees up and down the country.
All medical research involving people in the UK, whether in the NHS or the private sector, first has to be approved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial.
What are the benefit of clinical trials? Well, they can benefit us in many ways. For example, clinical trials can:
- prevent illnesses by testing a vaccine
- detect or diagnose illnesses by testing a scan or blood test
- treat illnesses by testing new or existing medicines
- find out how best to provide psychological support
- find out how people can control their symptoms or improve their quality of life – for example, by testing how a particular diet affects a condition
Many clinical trials are designed to show whether new medicines work as expected. These results are sent to the MHRA, which decides whether to allow the company making the medicine to market it for a particular use. The company usually applies for a twenty year patent to cover the research and marketing of the drug exclusively.
If research has identified a new medicine, the MHRA must license it before it can be marketed. Licensing shows a treatment has met certain standards of safety and effectiveness. The safety of the medicine must be monitored carefully over the first few years of a newly licensed treatment. This is because rare side effects that weren’t obvious in clinical trials may show up for the first time.
You may not have been selected for a trial but you may express interest in the results. You can find various results of clinical trials from sources such as:
- The Lancet medical journal
- British Medical Journal (BMJ)
- The New England Journal of Medicine
- Cochrane Library – a collection of high-quality evidence
- NHS Evidence database
Many of these publications offer abstracts, which are shorter summaries of the research. If you wish to delve deeper,
you usually have to take up a subscription to the journal. But before you do so, consider that research papers are not written in plain English and often use many medical, scientific and statistical terms which then make them possibly very difficult to understand.
The mainstream media offer a more readable version of the research. But do bear in mind, too, that while news stories are easier to read than original research papers, sometimes the findings are exaggerated or sensationalised in order to sell papers!