Understanding clinical trials
If you are being treated in the NHS you may be asked to take part in a clinical trial/study. Clinical trials/studies are different types of research studies that involve patients or healthy people. They aim to test whether different treatments are safe and how well they work. Clinical trials/studies are carried out to try to answer specific questions about health and illness.

Clinical trials/studies cover a broad range of different types of research for health interventions such as drugs, diagnostics, devices & therapy treatments. For example, trials are often used to test new medicines or interventions but can also be observational studies (no treatment/medicines involved) in which educational programmes designed to improve a person’s understanding of their medical condition and help them to manage it more effectively, or a psychological treatment, such as the use of cognitive behavioural therapy for the treatment of anxiety or depression. They can also be used to test whether giving a treatment in a different way will make it more effective or reduce any side effects. Some trials/studies are designed to try out ways to prevent a particular disease in people who have never had the disease, or to prevent a disease from returning.

Clinical trials/studies allow safety and efficacy data to be collected and can take place only after satisfactory information has been gathered and ethics committee approval is granted in the country where the trial is taking place. In the UK, review by an ethics committee is only one of a series of safeguards intended to protect the people taking part in the clinical research.

Choosing to participate in a clinical trial is an important personal decision. The following provides detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition.

The clinical trial/study team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Why are clinical trials important?

Clinical trials are the best way to compare different approaches to preventing and treating illness and health problems. Health professionals and patients need the evidence from trials to know which treatments work best. Without trials, there is a risk that people could be given treatments which have no advantage, waste resources and might even be harmful. Many treatments that are now in common use in health care were tested in clinical research.

What are the different types of clinical trials?

• Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy

• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

• Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Taking part in a clinical trial

Many patients voluntarily take part in research as ‘participants’ in clinical trials or other well designed studies. These trials aim to test how good beneficial treatments might be for people. Participants often have the particular health condition that the treatment aims to help. However, sometimes they can also be healthy volunteers.Treatments are tested on participants in strictly controlled ways to ensure safety and clear results. 

Most trials need many participants because they aim to find out what treatments are likely to be most helpful for the largest number of people.

If you would like more information about taking part in research as a patient in a clinical trial or other well designed studies take a look at our leaflets, 'Understanding clinical trials' and 'Clinical trials: what they are and what they are not'.

Research plays an important part in the development of new methods of cancer treatment and care. When the NCRN was established in April 2001 only about 4 in every 100 cancer patients took part in clinical trials. If more patients become involved, cancer research is able to move forward more quickly. New cancer treatments are usually studied in a sequence of clinical trials with increasing numbers of patients taking part as the sequence progresses.

• Phase I studies have a small number of patients and aims to work out what happens to the drug inside the body and what its side effects may be.

• Phase II studies then help doctors to work out the dose and frequency of a new treatment, and which particular cancers respond best to it. 

• Phase III studies compare the new treatment with the best treatment currently available to see if the new treatment is an improvement.

The Cancer Research UK website can help you to search for UK clinical trials including those that are currently recruiting patients, closed trials, or trials with results.

• Clinical trials contribute to knowledge and understanding.

• Many of the treatments available today have been tested in clinical trials.

• Clinical trials can improve patient care by developing new and effective treatments for cancer.

• Clinical trials establish whether promising approaches to cancer prevention, diagnosis and treatment are safe and effective.

The research team are the people who will initially talk to you about the trials that you can participate in, and can guide and support you during your treatment. The research team includes your consultant and their medical team, research nurses, data managers, trials practitioners/radiographers and the clinical trials pharmacist.

Members of the research team will outline what taking part in a clinical trial involves, the potential side effects, risks to you, other treatments available, and provide you with written information for you to take away and read. They will include a contact name and number so that as you consider the option of being treated on a trial you can contact them to ask any questions that you may have.

If you decide to take part in a clinical trial your research nurse or a member of the team will support you while you have your treatment. If you have any concerns about the treatment and its effects, you can talk to a member of the research team when you visit the hospital or you can telephone them. On completing your treatment, your consultant and the research nurse or research team member will monitor your progress and be available for advice.

If you decide not to take part in a trial or wish to withdraw from a trial, you will continue to receive appropriate treatment and care.

Other members of the team will be working more in the background collecting the information needed from your medical notes to monitor the effects of the treatment you are receiving. For example the trials pharmacist who will be preparing your treatment may speak to you about the drugs you are given.

We will work closely with any other health care professionals involved in your care and will be able to refer you to them should the need arise.

More information about getting involved in clinical trials can be found on the National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC) website.

NCRN is building a complete picture of the cancer clinical research which is currently taking place across the UK.

Details of studies which meet specific eligibility criteria are recorded in a database, known as the NIHR CRN CC Clinical Research Portfolio, which comprises the National Institute for Health Research (NIHR) Portfolio in England, and the corresponding portfolios of Northern Ireland, Scotland and Wales.

The NCRN promotes and co-ordinates clinical trials and other studies funded by the following organisations, who are currently members of the National Cancer Research Institute (NCRI):

- Medical Research Council (MRC)

- Cancer Research UK

- Leukaemia Research Fund (LRF)

- Department of Health

All clinical trials and other good quality studies, which have been approved by both the NCRI and NCRN, are available to PBCRN.

For further information, advice and support in your local area please visit our patients and carers page.

• Information from the NHS about clinical trials

• Searchable database of ongoing and completed clinical trials in the UK

• UK Clinical Trials Gateway

• Directory of pharmaceutical industry-funded clinical trials

• The U.S. National Institutes of Health

• Opportunities for public involvement in clinical research