Public Involvement in Clinical Trials

What is Patient and Public Involvement (PPI)?

Patient and Public Involvement, or PPI, means working with people who have personal experience of a health condition or service to help shape and guide research. People who get involved are called 'public contributors'.

Who can take part?

Anyone with personal or lived experience of a health condition, care service, or life situation related to the research can be a public contributor. This includes patients, carers, parents, family members, or people from community groups or charities. You don't need any special training—your experience and views are what matter most. There are no right or wrong answers, everyone's input is valued and we welcome people from all backgrounds and with different life experiences.

Public contributors are vital to research, they can help by:

• Asking important questions – to make sure the research is easy to understand and not confusing.
• Sharing real life views – to help the researchers think about how the study affects people taking part.
• Giving advice and speaking up for patients and families – so their voices are heard during meetings.

You can find general information about PPI in the NPEU here https://www.npeu.ox.ac.uk/public-involvement

What are the PPI roles in a clinical trial?

There are several stages of a clinical trial and public contributors are involved throughout, from the initial trial design through to the final sharing of results. In a clinical trial, we are usually looking for people to take on one of three different PPI roles.

1. PPI Co-applicant

A PPI co-applicant is a public contributor who is part of the main research team applying for money to do a research study. They will be part of a group called the co-applicant group. A co-applicant means someone who helps write and plan the research project from the start.

A PPI co-applicant:

• Helps to develop the right research question
• Makes sure the study is useful and important to patients and families
• May help write parts of the application to get funding (money)

A PPI co-applicant will often be involved throughout the whole trial and whilst they meet more when the trial is being set up, once it is set up, they may meet up to twice a year to get an update on how the trial is going. Meetings normally take place remotely online, during office hours.

2. PPI Trial Steering Committee

Every trial has a Trial Steering Committee (TSC). A TSC is a group of people who help make sure a trial is being done properly. This group checks that:

• The trial is safe for the people taking part
• The researchers are following the agreed plan (called a “protocol”)
• The trial is being done fairly and to a high standard

The TSC will include people with relevant experience and knowledge (such as doctors, other clinicians, and public contributors). These people are usually independent (not part of the main research team). It will also include some members of the research team. Public contributors are vital to a TSC. They bring a different point of view that doctors and researchers may not think of.

A TSC normally meets once a year to review performance of the trial. There will often be a report to read before the meeting. Meetings typically take place online, remotely, during office hours.

3. PPI Parent/Public Advisory Group

A Parent/ Public Advisory Group is a group that brings together several public contributors with real-life experience of a particular health condition. A Parent/ Public Advisory group is like a focus group. It helps the research by:

• Sharing honest feedback on what matters most to families
• Checking study materials (like leaflets and consent forms) to make sure they are clear and easy to read
• Advising on how to invite families to take part in research in a kind and inclusive way
• Helping to interpret results – so the findings make sense from a parent's point of view
• Suggesting ways to share findings with families and the wider community

They normally meet up to twice a year remotely, although this can be more frequent when the trial is being set up. Meetings are usually in the evening, to make it easier to take part around family and work commitments.

Getting in Touch

If you have any questions about PPI please do get in touch via email: ctu@npeu.ox.ac.uk.