Research and clinical trials
A clinical trial compares the effects of one treatment with another.It may involve patients, healthy people, or both.
How do I take part in a clinical trial?
Why join a clinical trial?
Will I get paid?
What should I know before I sign up?
How are trials regulated and judged ethical?
How are trial results used to improve treatment?
Where can I find results from trials that are relevant to me?
You can askyour doctor or a patient organisation if they know of any clinical trials that youmay be eligible to join.
You can also search for information on a number of websites and register your interest in taking part in research. The main ones are described below.
The UK Clinical Trials Gateway (UKCTG) website pulls through information about clinical trials and other researchfrom several different UK registers.If yousign up to it, researchers can contact you about research that might be suitable for you.
You can alsosearch the UKCTG site in various ways to find trials relevant to you, and you cancontact researchers yourself.
TheWorld Health Organization's Clinical Trials Search Portal provides access to clinical trials in countries all around the world.
For some conditions, you can find out about clinicaltrials from the websites of charities.
Clinical trials help doctors understand how to treat a particular disease or condition. It may benefit you, or others like you, in the future.
If you take part in a clinical trial, you may be one of the first people to benefit from a new treatment.
However, there is also a chance that the new treatment turns out to be no better, orworse, than the standard treatment.
To hear other people's experiences of taking part in a clinical trial, visit healthtalk.org: clinical trials .
Some clinical trials offer payment, which can vary from hundreds to thousands of pounds depending on what is involved and expected from you. Some trials don't offer payment and just cover your travel expenses.
It's important to find out about the inconvenience and risks involved before you sign up, and to carefully weigh up whether it is worth it.
Bear in mind:
All clinical trials of new medicines go through a series of phases to test whether theyare safe and whether they work.
The medicines will usually be tested against another treatment called a control. This will either be a dummy treatment (a placebo) or a standard treatment already in use. Learn moreabout the placebo effect .
Phase one trials :
Phase two trials:
Phase three trials:
Phase four trials:
If you take part in a clinical trial, you will usually be randomly assigned to either the:
While the treatments are different in the two groups, researchers try to keep as many of the other conditions the same as possible.
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 randomlydecide which group each patient will be allocated to.
Many trials are set up so 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.
When you express interest in a trial, a doctor or nurse is likely to tell you something about it in person. You'll also be given some printed information to take away. You may come back with some questions you feel haven't been answered.
As with any treatment, you can't be sure of the outcome. You may be given a new treatment that turns out not to be as effective as the standard treatment. Also, it's possible you'll experience unexpected side effects.
And bear in mind 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.
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. You can also choose to leave at any point without giving a reason and without it affecting the care you receive.
At the end of the trial, the researchers should publish the results and make them available to anyone who took part and wanted to know the results. If the researchers don't offer you the results and you want to know, ask for them.
Some research funders, such as the National Institute for Health Research (NIHR) , have websites where they publish the results of the research they have supported.
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.
The MHRA inspects sites where trials take place to make sure they're conducted in line with good clinical practice.
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 tobeapproved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial.
Clinical trials can help:
Many clinical trials are designed to show whether new medicines work as expected. These results are sent to theMHRA, which decides whether to allow the company making the medicine to market it for a particular use.
If research has identified a new medicine, the MHRAmust license it before it can be marketed. Licensing shows a treatment has met certain standards of safety and effectiveness.
Safety 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.
In England and Wales, the National Institute for Health and Care Excellence (NICE) decides whether the NHS should provide treatments.
The results of clinical trials are usually published in specialist medical journals and online libraries of evidence.
Some of the most well-known examples are:
You can use a search engine such as Google to look for articles and read summaries (abstracts). But you can't usually see the full articles without a subscription to the journal.
Also, research papers are not written in plain English and often use many medical, scientific and statistical terms. They can be very difficult to understand.
You'll often see stories about research findings in mainstream media. But while news storiesare easier to read than original research papers,sometimes the findings are exaggerated or sensationalised.
The NHS websiteaims to make this clearer for you. Behind the Headlines is an independent service that analyses health stories that make the news.
It aims toexplain the facts behind the headlines and give a better understanding of the research that was carried out.
Research and clinical trials are an everyday part of the work carried out by the NHS.
When Sheila was diagnosed with breast cancer, her GP suggested she join a clinical trial for a new breast cancer medicine.
When Kathleen Pemberton developed rheumatoid arthritis, she decided to take part in a clinical trial of a new treatment.
Christine Gratus discovered she had breast cancer after attending routine NHS screening.
When Nigel Lewis-Baker was told he had advanced prostate cancer, it was too late for surgery or radiotherapy.
Karen Ayres has an aggressive form of multiple sclerosis (MS). The severity of her symptoms varies, but at their worst she was paralysed from the neck down.