Inclusivity in clinical trials

There is growing commitment in the UK to address barriers to participation in clinical trials for diverse groups of people, as it is increasingly recognised that without doing so, trial results may not accurately represent the whole population.  

Last year, in this spirit, we undertook two projects which sought to address the issues surrounding representation and inclusion in clinical trials. Today, I am speaking at an event for ABPI sharing our work in this area, alongside Ailsa Bosworth, from member organisation NRAS, who will be speaking on this issue from a lived experience perspective. 

At the event I’ll be sharing some key insights from our work in this space so far and wanted to spread these messages more widely through this blog post. 

English literacy as a barrier to participation

English literacy as a barrier to participation in clinical trials looked at how patient information leaflets (PILs) could be improved to increase the diversity of people choosing to participate in research, and also sought to understand wider barriers to participation. 

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. This example is enough to discourage anyone from engaging with the material but puts up a very clear barrier for those 7.1 million adults who read at or below the level of an average 9 year old.  

We spoke with members and people with lived experience, sharing examples of two sample leaflets and discussing the peaks and pitfalls of each, and of PILs more generally. We heard a lot of support for PILs as a concept, our members told us how helpful it was to have something to take away for consideration. There was also recognition that steps needed to be taken to make them more accessible. 

Just some of what we heard: 

• Wording needs to strike the right balance between being simple but not patronising.
• Information about consent, side effects and details about getting in touch must be provided.
• A clear commitment to alternative formats is crucial; this could include large font, audio or video options. One participant noted:

With the INCLUDE study I was involved in, we took the patient information sheet and information produced five video podcasts in different South Asian languages as a way to make it more accessible to reach those communities.

Our discussions also reflected on the need for genuine co-production, which would help to ensure the leaflets addressed people’s real concerns and supported their real lives. 

Addressing inequalities in clinical trials

Our second report on this topic, Addressing inequalities in clinical trials, sought to further identify and understand key barriers to participation in clinical trials for underrepresented groups, and set out the key solutions and areas for improvements. 

Our workshop for this project was attended by a mixture of professionals working with communities via health charities and people with lived experience of long term health conditions and/or disability.  

In our discussions, we acknowledged that barriers to participation in clinical trials were different for different people, however we identified three overarching themes which were common across groups: 

Attitudinal barriers

Attitudinal barriers are identified as including feat and mistrust from people and communities, and failure from those conducting the research to signal inclusion. Just one example we heard was: 

There’s a real lack of trust of medical professionals and establishments within some parts of the trans community. Hence the need for someone to almost say ‘we’ve vetted [the professional] and they’re ok’.

Communication barriers

These include a lack of outreach and awareness and digital exclusion. We heard: 

The clinical trial units… and the researchers don’t reach out into the communities as well as they should do, so they don’t have awareness of where to go, how to reach those communities that they need to.

Practical barriers

Practical barriers include a range of things that may make it harder for some groups of people to get involved with clinical and research trials. This includes barriers faced by people on lower incomes, people who are carers, those living in rural areas, and barriers that arise due to the way trials are designed. All of these also interlink with digital exclusion. 

Around the barriers faced by carers, one participant said: 

Because they’re responsible for somebody else who quite significantly relies on them, [people will be] really worried about [whether the trial] will affect their ability to care?

Our recommendations

The report includes a set of seven key solutions to help widen participation in clinical and research trials, based on suggestions from participants: 

1. Demystify research – work is needed to explain the research process to people. 
2. Use a range of communications tools – information must be provided in a wide range of formats, in line with accessible communication standards. 
3. Work with the VCSE sector and community groups – these organisations have existing networks and established trusting relationships with the ability to act as vital intermediaries. This work needs to be valued and renumerated adequately. 
4. Address bias and discrimination – there is significantly more work to be done to break down damaging biases and to address discrimination across research. 
5. Give people a fair deal – those running clinical trials must make a more comprehensive offer of varied support to those taking part in trials. Participating in trials can be burdensome, especially for people who are living with health inequalities.  
6. Shift the power dynamics – gaps in representation will not be addressed without a move to more equal power sharing between all those involved. 
7. Commit to co-production – participants talked about a shift towards coproduction throughout the entire clinical trial’s process.  

Our shareable graphics

Our graphic below illustrates the key sections and themes from the report: 

This, along with a less detailed version is available to download via our website.

Next steps

When people and communities are missing from research, they are missing from results. At best, this can lead to missed insights about how different treatments work for different people, at worst, it can have potential patient safety implications. 

Through both of these projects, one key fact rang true, which was the need for genuine co-production, with the VCSE and community groups, and people with lived experience, in designing patient information and designing studies from the ground up.  

We are encouraged by the work being undertaken in this space to ensure that we do better when it comes to diverse representation in clinical trials, and stand ready to support other work in this space.