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Medical research Content Supplied by NHS Choices
Introduction

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 happens in a clinical trial

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

How do I 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.

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.

UK Clinical Trials Gateway

The UK Clinical Trials Gateway (UKCTG) website pulls through information about clinical trials and other research from several different UK registers. If you sign up to it, researchers can contact you about research that might be suitable for you.

You can also search the UKCTG site in various ways to find trials relevant to you, and you can contact researchers yourself.

WHO International Clinical Trials

The World Health Organization's Clinical Trials Search Portal provides access to clinical trials in countries all around the world.

Charities

For some conditions, you can find out about clinical trials from the websites of charities.

Examples are:

Why join a clinical trial

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, or worse, than the standard treatment.

To hear other people's experiences of taking part in a clinical trial, visit healthtalk.org: clinical trials.

Will I get paid

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:

  • it 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
  • 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
  • you may experience unknown side effects from the treatment

What happens in a clinical trial

Testing a new medicine

All clinical trials of new medicines go through a series of phases to test whether they are 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 more about the placebo effect.

Phase one trials:

  • A small number of people, who may be healthy volunteers, are given the medicine.
  • The drug is being trialled in human volunteers for the first time.
  • Researchers test for side effects and calculate what the right dose might be to use in treatment.
  • 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.

Phase two trials:

  • The new medicine is tested on a larger group of people who are ill. This is to get a better idea of its effects in the short term.

Phase three trials:

  • Carried out on medicines that have passed phases one and two.
  • The medicine is tested in larger groups of people who are ill, and compared against an existing treatment or a placebo to see if it's better in practice and if it has important side effects.
  • Trials often last a year or more and involve several thousand patients.

Phase four trials:

  • The safety, side effects and effectiveness of the medicine continue to be studied while it is being used in practice.
  • Not required for every medicine.
  • 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.

Control groups, randomisation and blinding

If you take part in a clinical trial, you will usually be randomly assigned to either the:

  • treatment group - where you'll be given the treatment being assessed, or
  • control group - where you'll be given an existing standard treatment, or a placebo if no proven standard treatment exists

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 randomly decide 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.

What should I know before I sign up

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.

General questions

  • 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.

Practical questions

  • 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

Things to weigh up

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.

Leaving a trial

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.

Results

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.

How are trials regulated and judged ethical

Role of 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.

The MHRA inspects sites where trials take place to make sure they're conducted in line with good clinical practice.

Role of the HRA

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.

How are trial results used to improve treatment

Clinical trials can help:

  • 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.

Licensing a treatment

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.

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.

Where can I find results from trials that are relevant to me

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.

Coverage in newspapers

You'll often see stories about research findings in mainstream media. But while news stories are easier to read than original research papers, sometimes the findings are exaggerated or sensationalised.

The NHS website aims to make this clearer for you. Behind the Headlines is an independent service that analyses health stories that make the news.

It aims to explain the facts behind the headlines and give a better understanding of the research that was carried out.

'The nurse made sure I understood the risks'

When Kathleen Pemberton developed rheumatoid arthritis, it progressed rapidly. Within six months she was in serious pain. Most of her joints were inflamed and she had difficulty moving around.

At her first consultation at Whipps Cross Hospital in Leytonstone, east London, the specialist suggested she consider taking part in a new clinical trial.

''It was a trial of a new treatment that had been accepted for use in America, but needed to be tested in England,'' says Kathleen.

''I was keen to take part because the painkillers I was on weren't working and I was looking for a treatment that did work. I didn't get paid any money, but I wanted to see if it could help.

''I saw a clinical trial nurse and she was thorough and helpful. She made sure I understood the risks. There was a series of consultations at the hospital, but not too many.''

While Kathleen received the medication through a drip into her arm, she was in a pleasant ward with plenty of cups of tea. She was given one of a group of medicines called TNF inhibitors, originally developed through NHS research at the Kennedy Institute in London.

Kathleen's condition improved, and when the trial finished two years later she went on to another TNF inhibitor medicine that had already been approved for health service use.

Kathleen says that, looking back, she would take part in a trial again. ''Everybody was so kind and nice. I would recommend it to anybody. You're well looked after.''

It was a bonus for Kathleen to know she was a small part of the research that established TNF inhibitors as an important part of rheumatoid arthritis treatment.

''The pain and mobility problems of rheumatoid arthritis are beyond belief. You're in pain all the time.

''I'm pleased to have been one of the people who've shown how these treatments can help people with rheumatoid arthritis.''

'I'm here because of women who took part in research'

Christine Gratus discovered she had breast cancer after attending routine NHS screening.

She says she's one of many people who are grateful to women who had taken part in previous research.

''I'm here because of all the research that was done before I found out I had breast cancer,'' she says.

''I'm here with perfectly formed breasts thanks to women who took part in research that discovered that a lumpectomy (surgery to remove a small piece of breast tissue) is just as effective as a full mastectomy (removing the entire breast).

''I'm also here because of the women before me who took part in research on radiotherapy, surgery, and chemotherapy.''

In turn, she also took part in research. ''We have responsibilities as well as rights in this area. If we want treatment for breast cancer and other conditions to improve further, we have a responsibility to the women who come after us.

''People rightly make a fuss about getting the most effective treatments. But a lot of the time we don't really know what the best treatments are, and without more research we never will.''

Christine took part in a trial to see whether it was better to let fluid drain away from the site of surgery or to use a pump, and in another trial that looked at how radiotherapy could best be target=""=""=""ed and at what doses.

She acknowledges the main reason she took part in the research was because she thought she would receive the best possible level of care.

''When I was diagnosed, I read about breast cancer and found that I was likely to get the best standard of care, whichever arm of the trial I was in.

''I'm really pleased that I may have helped some of the women who are being diagnosed with breast cancer now.''

'I thought it might help me or someone else'

When Nigel Lewis-Baker was told he had advanced prostate cancer, it was too late for surgery or radiotherapy as he had probably had a fast-growing form of the disease for several years.

The only choice was one of two types of hormonal treatment. This worked for a while, but the cancer returned and he stopped taking the hormone treatment.

Nigel was then asked if he would like to take part in a trial for a new type of vaccine to treat prostate cancer. After careful consideration, he agreed. ''I thought it might help me, or it might help someone else,'' he says.

He never knew whether he was on active treatment or dummy placebo injections. But he says, ''I hope it was the placebo, because whatever it was, it didn't work for me. My PSA levels (which act as a marker for cancer growth in prostate cancer) started to climb again.''

Nigel was then switched to two types of hormone and the growth of his cancer slowed down again.

He has no regrets about being in the trial. ''I was glad I did it, even though it didn't seem to have helped me personally. I hope the findings will benefit other men. I would certainly not hesitate to do it again.''

'I'm lucky I found a trial that was so right for me'

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.

''I was in a dire situation,'' she says. Her doctor at the NHS Walton Centre for Neurology in Merseyside suggested she might be suitable for a clinical trial of a combination of treatments. One was a form of chemotherapy often used in cancer treatment, and the other was a medication already used for MS.

It was an untested and risky option. The chemotherapy part of the treatment posed a small but definite risk of leukaemia, and it was uncertain whether or not the combination would do any good.

''My doctor was very open and honest about the risks. He emphasised that there was no guarantee that the combination would work, and that if it did, it wasn't certain that any improvement would be sustained.''

Karen decided to take part in the trial. Her feeling that she was being told about the possible harms, as well as the benefits, helped her make her choice.

''I was running out of options,'' she says. ''Even so, you have to go into a clinical trial hoping it will work, but knowing that it might not. You can't go into a trial lightly - you need to know things and ask a lot of questions.''

She says she is fortunate to have been able to enter the trial. She was only the twelfth person to have the treatment. She also feels pleased to have been able, ''in a very small way'', to help find an effective treatment for some MS patients. ''I did my bit for science, and I hope the research will help other MS researchers.''

Sheilas-story

 
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