Clinical trials of new medicines or health technologies rely on patients, carers or even healthy volunteers agreeing to take part in research and it is therefore vital that patients have a say in how this research is done. For this reason, patient and public involvement (PPI) is heavily embedded into research conducted at the Southampton Clinical Trials Unit.

But we know that certain groups and communities are under-served by clinical research. We therefore need to ensure that PPI in the design and conduct of our trials is reflective of the whole population, to encourage more people from diverse backgrounds to take part in research.

With funding from the Univeristy of Southampton's Publice Engagment in Research Unit (PERu), we carried out a community-based study involving focus groups and online interviews to help us better understand the barriers that may prevent or dissuade people from under-served groups from taking part in PPI for clinical trials and learn how we can overcome these.

Using information and comments from these sessions, we have co-produced a video and resources that can be used by researchers to reduce these barriers when conducting PPI as part of their future research projects, improving the diversity and inclusion of patient and public involvement and making healthcare research better for everyone.

Resources

Through the Widening Participation project, we identified eight key themes that are important for making PPI inclusive and accessible to diverse communities:

Many of these themes overlap and require similar steps from research teams to implement change. We have created prompt cards to help you incorporate these inclusive practices into your PPI.

Download the themes and prompt cards

Watch the video

This video was co-produced with the team at Drop The Mask Productions CIC, a Southampton-based media and IT company who promote inclusive employment opportunities and who helped facilitate one of our focus groups. The video contains direct quotes from people involved in the Widening Participation project and is voiced by some of those who took part.

 

Study background

To make sure that the information we learn from clinical trials applies to everyone, we need to involve people from diverse backgrounds in our research. If we only include mainly white populations, it may mean that our findings won’t help the whole population, and this could increase existing health inequalities. For example, we know that prostate cancer is more common in Black men than in White men*. But if we only test a new treatment in clinical trials involving White men, how do we know that the treatment will work for everyone?

Despite work at the Southampton Clinical Trials Unit (SCTU) to engage and involve people from different ethnic groups, the people currently taking part in our studies do not always represent the race and ethnicity of the whole population or those affected by different diseases.

We’ve already looked into the challenges faced by ethnic minority communities in patient and public involvement (PPI) activities for clinical trials through our Widening Participation Project. This information helped us to understand the barriers some people face to participation and create materials to encourage more diverse people to join SCTU trial committees.

With funding from Research England's Participatory Research Fund, we have been able to continue this work and build on the relationships we’ve made with diverse communities here in the South. This project aims to improve the ethnic diversity of people taking part in clinical research by working with these communities to design patient-facing materials and an online forum.

 

Community engagement and co-production

The project used community engagement and co-production methods to bring together our research team and the local community through a series of face-to-face workshops with people from diverse ethnic backgrounds. Using creative approaches, small discussion groups and iterative feedback we discussed existing trial materials and how these can be improved and made more engaging to people from ethnic minority communities.

Together, we co-designed a template framework for research teams designing new patient-facing trial materials and a prototype for an online “safe space” to encourage a more diverse group of participants in our clinical trials. 

Patient-facing materials:

Through the creative workshops, we:

• Gathered feedback on our current patient-facing trial materials such as adverts, invite letters, participant information sheets, and trial videos.
• Discussed in-depth how to improve language, content, and specific information that may be important for diverse ethnic groups, as well as culture considerations and sensitivities.
• Together, we co-designed a template Framework to help research teams and patient and public representatives create and review updated patient-facing materials.

The template Framework was then reviewed by another, independent group of ethnically diverse public contributors from across the UK who provided feedback on its useability and usefulness from the point of view of a public reviewer of patient-facing documents.

Online “safe space”

Through the workshops, we also created a prototype design for an online “safe space” for new and current trial participants. This will be a website and community forum where people can ask questions about trials anonymously, increasing engagement and information exchange between researchers and people different ethnic groups.

Questions addressed during the initial workshops included:

1. How can we achieve a common goal/purpose?
2. What is the best platform for this “safe space”?
3. What are the ground rules or guidelines we should follow?
4. How can the “safe space” encourage participation and inclusion while building and maintaining trust?
5. How will feedback and support be provided?
6. How will anonymity be respected?
7. How many advocates for the “safe space” are needed for it to work as intended?
8. The group will work together to co-design the concept and look of the “safe space”, including any materials or videos explaining how to use the platform.

Working with a website designer, we then brought the group's ideas to life with a mocked-up website and held more workshops to gather further feedback and suggestions for how the "safe space" could work in practise. This led to the co-creation of a name and logo, a colour palette and basic website design, suggested content and essential information, as well as ideas for how to make the forum interactive and encourage two-way conversations between communities and clinical research teams.

Outcomes and next steps

The framework for creating and reviewing patient-facing materials will now be tested and evaluated in several SCTU clinical trials. We are also applying for impact funding to test the framework across a wider portfolio of trials and link with other Clinical Trials Units in the UK to gather further evaluation.

We are also applying for further funding to turn the prototype "safe space" design into a functioning website, through further co-production workshops within the community. Once created, we will carry out user-testing and evaulation of the website through community engagement events and through its use in SCTU clinical trials. 

The outcomes of this project will be showcased in an academic poster session at the International Clinical Trials Methodology Conference at the end of September 2024. This will include showcasing the template framework and prototype "safe space" for feedback from the clinical trials community. 

If you are part of a Clinical Trials Unit (CTU) or a researcher who would like to keep up to date with our project or help evaluate the project outputs, please contact the research team.

To learn more about our clinical trials and Patient and Public Involvement at SCTU, visit the Southampton Clinical Trials Unit website .

* Information from Cancer Research UK