If you have never taken part in a clinical trial before, it can be difficult to imagine what the process actually involves.
Will you need to visit the hospital every week? Will you have blood tests? Can you continue taking your usual medication? And what happens if you no longer want to take part?
Every clinical trial is different, but many follow some of the same general steps. We take you through what you can typically expect, from the first contact to the final follow-up.
First Contact and Initial Screening
The first step is often to find out whether a study could be relevant for you. This may involve a short telephone conversation or questionnaire, where you are asked about your age, diagnosis, symptoms, current treatment and any other medical conditions.
Clinical trials have specific criteria that determine who can take part. This means that being interested in a study does not necessarily mean that you will be eligible to participate. The purpose of the initial screening is both to identify people who may be suitable for the study and to help protect participants’ safety.
Receiving Information About the Trial
If the study appears to be relevant for you, you will receive more detailed information about the trial. Clinical trial participants are entitled to receive both verbal and written information before deciding whether they would like to take part.
This should include information about:
- The purpose of the trial
- What participation involves
- How long the trial will last
- Which examinations and visits are involved
- Possible benefits, risks and side effects
- Which treatment you may receive
You will have the opportunity to ask questions and take time to consider your decision.
You Give Consent if you Choose to Participate
If you decide that you would like to continue after receiving the information, you will be asked to give your consent to take part. It is important to remember that participation in a clinical trial is voluntary.
Giving consent also does not mean that you are committed to completing the entire trial. You can later choose to withdraw your consent and stop taking part.
Screening at the Hospital or Trial Site
The next step is often a more thorough screening. Exactly which examinations are carried out will depend on the individual study. They may include:
- Measuring your blood pressure, pulse or weight
- An ECG
- Scans
- Questions about your health and medical history
- A review of any medication you are already taking
The screening is used to assess whether you meet all the study criteria and whether taking part is considered safe for you.
If You are Included in the Trial
If you meet the study criteria, the trial itself can begin. In some studies, all participants receive the same treatment. In others, participants are randomly assigned to different groups. This is known as randomisation. For example, one group may receive the treatment being investigated, while another receives an existing standard treatment or a placebo.
The way the trial is designed should be explained in the information you receive before deciding whether to take part.
Visits and Examinations During the Trial
During the trial, there will typically be a number of planned follow-up visits.
Researchers will monitor how you are feeling, whether the treatment is working as expected and whether you experience any side effects. A visit may include conversations with the research team, blood tests, examinations, questionnaires or receiving trial medication.
Some studies require many visits, while others require only a few. Decentralised clinical trials are also becoming more popular, enabling parts of your participation to take place at home or closer to where you live.
Can You Stop During the Trial?
Yes. Taking part in a clinical trial is voluntary, and in the UK you can generally withdraw your consent and leave the trial without having to give a reason.
If you are considering stopping, it may be a good idea to speak to the research team first so that you understand what this means in your particular study.
When the Trial Ends
When your participation comes to an end, there will often be a final visit or follow-up.
The researchers may carry out a final assessment of your health, record any side effects and end any treatment or medication that formed part of the trial. In some studies, follow-up continues for a longer period so researchers can learn more about the treatment’s effects and safety over time.
Every Clinical Trial is Different
There is no single experience of taking part in research.
Some trials last only a few weeks, while others continue for several years. Some require frequent hospital visits, while others can be carried out with fewer in-person appointments. The most important thing is therefore to read the information about the individual study carefully, ask any questions you may have and consider whether taking part is right for you.
Would You Like to Hear About Opportunities to Take Part in Research?
As a member of the British Research Panel, you can stay informed about relevant research projects and have the opportunity to learn more about studies that may be relevant to you.
Membership is free and without obligation, and you always get to decide whether you would like to hear more about or take part in a particular study.
Sign up here: Survey
Additional resources:
Clinical trials – NHS