Our work increasing diversity in clinical trials

English literacy as a barrier to participation in clinical trials

The MAPLE project

The MAPLE project, led by the Bristol Biomedical Research Centre and funded through the ICS Research Engagement Network (REN) development programme, aims to create accessible information for people who may be interested in taking part in research but find traditional patient information leaflets (PILs) too complex to engage with. 

For example, an evaluation of COVID-19 vaccine trials found the mean word count of PILs was over 8000, with an average reading time of 30 minutes to three quarters of an hour. 

Our work

We held a roundtable and a series of follow-up discussions with our members, and with people with lived experience, to identify how PILs should be improved and to understand wider barriers to participation in research. 

Our report, English literacy as a barrier to participation in clinical trials is the result of these discussions, and contains insightful quotes from participants.

Our findings and recommendations include:

• We saw positive support for the attempt to make PILs more accessible.  
• The ability to take away a written leaflet to consider the opportunity to take part in clinical research is a strong benefit.  
• Images make leaflets easier to understand, but they must be visually literate to the information provided.  
• Leaflet wording must strike the correct balance between being simple and making people feel patronised.  
• Leaflets need to contain more information around consent, side effects, and details around getting in contact.  
• People should be signposted to additional information or alternative resources after reading the initial leaflet.  
• There must be a clear commitment to providing alternative formats for those with additional communication needs.  
• Co-production is incredibly important – and needs to go much further, being extended to the entire research process. This could overcome wider participation barriers that were not within the scope of this project. 

Addressing inequalities in clinical trials

Our report, Addressing inequalities in clinical trials identifies key barriers to participation in clinical and research trials and potential ways to address these. While the data is imperfect, it is widely accepted that the majority of trial participants are white, British and affluent; this is not representative of the diverse range of people affected by the conditions for which medications and procedures are usually being trialled.

Fortunately, we are seeing a growing interest in, and commitment to, addressing these barriers among pharmaceutical companies, researchers, patient groups and others. 

Our work

To help inform the work currently underway to improve the representativeness of clinical and research participants, and to ensure that more people have the opportunity to participate in clinical and research trials, we undertook a consultation amongst our members, and Lived Experience Partners. 

Our report is the result of these discussions, and contains insightful quotes from participants, whilst also identifying the key barriers to participation in clinical trials, potential solutions to widen participation, and five key areas for improvement to promote inclusion and diversity across clinical research.

Barriers to participation in clinical trials

In our discussions, we acknowledged that the barriers to participation in clinical trials were different for different people, in different places, with different conditions and in different personal circumstances, and in relation to different trials.  

However, we identified three overarching themes, which were common across groups and which arose in relation to variation across trials:  

• Attitudinal barriers, including fear and mistrust from people and communities and failure from pharmaceutical and research companies to signal inclusion. 

• Communication barriers, including a lack of outreach and awareness and digital exclusion.  

• Practical barriers, including financial barriers, geographical barriers and a lack of support for carers.   

Potential solutions

We identified seven key solutions to widen participation in clinical and research trials: 

1. Demystify research. 
2. Use a range of communications tools. 
3. Work with the Voluntary, Community and Social Enterprise (VCSE) sector and community groups. 
4. Address bias and discrimination across research. 
5. Give people a fair deal. 
6. Shift the power dynamics.
7. Commit to co-production.

Taking action

There is much to be done to address inequalities in clinical and research trials and to improve inclusion and diversity across the clinical research world.  

We identified five key areas for improvement:  

1. Build capacity across the system. 
2. Improve communication around research trials.
3. Strengthen support for people who engage in research.
4. Engage the VCSE sector.
5. Shift the power dynamics by committing to co-production.

Shareable infographics

Alongside our report, we’ve also developed two infographics. They’re free to download and illustrate the key sections and themes from the report. We invite you to use these in your own work and share with anyone you think may be interested or find them useful. 

Acknowledgements

We would like to thank National Voices’ Associate Kate Jopling for her significant contributions towards both of these reports. 

We would also like to thank our member organisations and people with lived experience for sharing their insights and inputting into both of these pieces of work. 

English literacy as a barrier to participation in clinical trials

This activity was funded through the ICS Research Engagement Network (REN) development programme. The views expressed in this publication are those of the author(s) and not necessarily those of NHS England or the Department of Health and Social Care. 

Addressing inequalities in clinical trials

This work was made possible thanks to the generous contribution of Novartis who provided a grant towards this independent programme of work.