What happens on a study?

How the process works in practice

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All studies are designed differently depending on what is being researched.  

This page explains the process around most clinical studies and what you can expect before, during and after. Other research studies such as surveys, may be organised differently.  

Regulation around research is tight.  The rules are there to ensure that every phase of a trial or study is run safely.  Read more about how trials are regulated, approved and funded in the UK.

Giving your informed consent

Before you take part in a study, a doctor or other researcher should make sure you have given your informed consent. Before you can do this, you will need to understand the purpose of the trial and what taking part will  involve, including the main risks and benefits.

You'll need to know how the trial might affect you before you can give your consent.  We've provided a helpful list of questions.

Who will I meet on a study?

In this series of videos, Helen Cooke, one of our Research Champions, interviews a study team based in Chapel Allerton, Leeds.  The following series of videos explain the different people typically involved in a research study. 

Research assistant

A research assistant supports the team in a number of ways. They gather and interpret information, monitor patients and document evidence. Humal Cassamoali is a research assistant working in Leeds. Find out more about her in the video.

Research Nurse

In the next video, Kate Russell talks about her role as a Research Nurse and her liaison between looking after the patients taking part and supporting the researchers.  The role of the research nurse can be more diverse and include carrying out follow-ups, collecting data, maintaining site files, gaining and managing consent.

Principal Investigator

Dr Md Yusof is a Principal Investigator who manages the day to day running of the study. He tells us more about his role in the next video. A principal investigator is the doctor who leads the conduct of a study. They will look after the rights, safety and wellbeing of the people involved in the study. They also ensure that the results of the trial are credible and accurate.

Chief Investigator

Finally, we talk to Dr Ed Vital who is the Chief Investigator. His role is to oversee the whole project.  This role could be carried out by a doctor, dentist, nurse or pharmacist and takes primary responsibility for the conduct of the study.  They design, conduct and report on the findings of the study.

The design of studies

There are many different ways to design a study, depending on what’s being tested.  The researchers always want to get the most reliable results as possible, but sometimes the type of medicine or side effects cannot be disguised and therefore blind trials are not always possible.

Randomised trials

This is the most popular design for trials. In ‘randomised’ trials, you’ll be allocated to one or more groups randomly.  Usually with the help of a computer program so that each group has a similar mix of people of different ahes. You might be in the control group. Researchers run these trials as they give reliable results.

Controlled trials

Control trials are designed to compare different treatments.  Most compare a new treatment with the standard or usual treatment. People in the control group are not given any treatment at all.  You’re still a very important part of the trial: the results from this group are needed to compare with the results of the test treatment.

Don't forget, the treatment being tested may be no better than the control, which is why the trial needs to be done.

Blind trials

In a blind trial, researchers won’t tell you which which treatment you are getting. You could be getting the new treatment or you could get a standard treatment or a placebo.  You will be monitored in the same way, no matter what you’ve been given.  Blind trials are important because they offer reliable results. Researchers design blind trials because if you knew which treatment you were getting, it might influence how you feel or how you report your symptoms.

It’s not always possible to have a blind trial, as the treatment being tested might be too obvious. Where possible, the treatments need to look exactly the same.

Double-blind trials

In a double blind trial, neither you or the researchers know which group you are in. You will be allocated a patient number at random and sometimes this is done using a computer.  These numbers are also allocated to the treatment and this is kept secret until the end of the trial. 

Double blind trials give very neutral results because the doctors cannot influence the results at all. You can only have a double blind trial when both the treatment and the effects aren’t very obvious.  

How trials for new treatments are made safe

New treatments, or new uses for existing treatments, are tested in various stages – also known as "phases". This helps establish what becomes a new medicine and what doesn’t.

Before being given to people for the first time, all drugs are checked for safety in animals.

  • Phase 1 involves a relatively small number of people.
  • Phase 2  is used to find out whether a drug works, whether it’s safe and what the side effects are.
  • Phases 3 and 4 involve larger numbers of people and are designed to assess how the treatment works, compared with existing treatments, while continuing to assess side effects and risks.

New treatments versus standard treatments

Not everyone receives a new treatment in a clinical trial.  Sometimes trials need to compare a new treatment with the standard treatment already in use, if there is one.

  • Some people in a trial will receive the standard treatment but, until the results of the trial are analysed, no one will know which treatment is better.
  • New does not always mean better, so you are not always worse off if you don’t receive a new treatment.

Using a placebo

A placebo is a medicine or a treatment that looks exactly the same as the medicine/treatment being tested, but is designed to have no effect at all.

We can be biaised without realising it, as sometimes we believe we feel better because we’ve taken something we think will make us feel better.  This is known as the placebo effect. You can find other common terms in our glossary.

During a trial

Regular tests and side effects

Once you’re in a trial, the researchers will want to carry out regular tests to find out how your treatment is working and lookout for any side effects – so will ask questions about any new symptoms, including psychological symptoms.

The type and frequency of the tests may vary according to  the research you’re taking part in so be sure to ask what’s involved.

You may also be asked to fill out questionnaires or keep a diary. This might mean going to your hospital or GP more often, so bear this in mind before you agree to take part.

Support for you and your family

Researchers will also look at the wider effects of a treatment on your life as a whole – in other words, your ‘quality of life’. So they may ask if you can take part in your usual day-to-day activities, or if you need any extra help around the home or to look after your family.

After a trial

How will trial results be used?

At the end of a trial, the results should be made available to everyone who took part if they want them. Researchers should publish the results, regardless of what they show, and also demonstrate how the results add to available knowledge.

The Department of Health and Social Care/National Institute for Health Research insists on publication of the results of all research studies that it funds. At NIHR, we publish the results of all the research we fund in our Journals Library.

Because some studies can run for many years, it may be some time before the results are known.

Continuing your treatment

If you are having a new treatment as part of a trial, you might naturally want to continue that treatment after the trial ends. But in practice, it may not always be possible for you to do this.

It may be some time before a new treatment is provided by the NHS or in some cases new treatments are not made available on the NHS. In this case, you will be given the standard treatment for the condition you have.

In some circumstances you may be able to buy the new treatment on a private basis; for example, if the drug has a licence, but is not available on the NHS.

How is it decided whether to make a treatment available?

The National Institute for Health and Care Excellence (NICE) is a public body and part of its role is to recommend whether the NHS should buy new and existing treatments.

It makes these decisions based on how well a treatment works and if it represents value for money. Sometimes, treatment costs only become entirely clear after a trial.

It is impossible to be certain, when a trial starts, about whether or not the test drug or device will be made available on the NHS following the drug trial or research study.

Patients can get involved with NICE's work.