What to expect
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 studies are regulated, approved and funded in the UK.
- Anyone - providing you’re over the age of 18.
- You might or might not have a diagnosis or you might care for someone who wants to take part and wants some more information.
- Each study has its own specific checklist for who can take part – this is called an eligibility criteria. You can find this information when you click on ‘full study details’ on every study on this site.
- Before enrolling in a study, the research team will go through this criteria with you.
Do I need to travel to a hospital to take part in research?
Research can happen in lots of places: at an NHS hospital or health centre, at a university or research institute, in a care home, or in some cases, in your own home. What the study involves will often determine where it will take place. For more on the practicalities, read about how to take part in a study. Find more frequently asked questions.
How much time does it take?
There are lots of different studies that take up different amounts of time. Some studies are online (you can search for these by typing online into the search box at the top of the screen) and some involve longer periods of time and are more involved. Decide what time you could set aside to help around your commitments and then find studies that fit with you.
Will I get paid to take part in research?
Most research studies in the NHS rely on volunteers to participate. The majority of studies on this website are based in the NHS. You may be reimbursed your travel expenses so it's worth talking to the study team about what financial reimbursements are available.
Before you take part in a study, a doctor or other researcher should make sure you give your informed consent. This means giving your permission. You'll need to know how the trial might affect you before you can do this. We've provided a helpful list of questions to ensure you have the right information so that you can confidently give permission to take part.
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 biased 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.
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.
Health and social care research studies are carefully designed to minimise the risks and maximise the benefits to all who take part, whatever treatment they receive. But this can be difficult, especially when you’re not a health professional yourself.
- Some trials will have very little risk, for example completing a survey or providing samples.
- The risks of a trial may be greater when less is known about the treatment being tested. The treatment may cause side effects that doctors and clinicians cannot predict. These may be unpleasant and, very rarely, can be life-threatening.
Risks and side effects
You should be told everything that the researchers know about any possible risks and side effects and why the trial is necessary, so that you can make an informed choice about whether to take part. All research studies are regulated and should meet ethical approval.
If you take part in a trial you will be monitored regularly during and after the study.
What happens if something goes wrong?
If you decide to take part in a drug trial or more agree to try a new procedure you may want to find out exactly what arrangements have been made for compensation before agreeing to take part.
- It’s rare for patients to be seriously harmed by trial treatments.
- Before any trial can start, arrangements have to be put in place in case something goes wrong and people are harmed.
- Research ethics committees can refuse approval for trials where there is no insurance or other provision for compensation. Visit how trials are regulated, approved and funded.
- Drug companies are insured so that, if a patient suffers because of a trial, compensation can be paid.
- Trials funded by other organisations may not have this kind of insurance, but a payment may be made if something does go wrong.
- Individual NHS trusts are responsible for ensuring themselves against damage caused by their own 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.
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.
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.
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.
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.
A research study team typically includes:
A research assistant supports the team in a number of ways. They gather and interpret information, monitor patients and document evidence.
The role of the research nurse can be more diverse and include carrying out follow-ups, collecting data, maintaining site files and gaining and managing consent.
A principal investigator is the doctor leading how a study is delivered. They will look after the rights, safety and wellbeing of the people taking part in the study and ensure the results of the trial are credible and accurate.
The Chief Investigator oversees 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.
How will my information be used?
- If you enrol in a research study, the research team will collect information as part of that particular study. This information is held by the research team and any information that is collected about you will be kept confidential, in the same way as your medical records.
- The researchers cannot tell anyone that you are in the study without asking you first.
- If your doctor or consultant is not the person who approached you about the trial, it can be helpful for them to be told you are taking part in a study as they will be responsible for your day-to-day healthcare; but they can only be told with your permission.
- Once the study has finished the results are usually published, and often presented at conferences. No name or any information that can identify you will be used in any reports about the study.
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 NIHR 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 find out more about their public involvement work and how it's used to develop new medicines and services.