Vision for diversity

As we enter a new era of inclusivity are we really doing enough to improve health equity in clinical trials?

Ash Rishi, Founder and CEO of COUCH and Nina Vadjaraganian, Associate Director at Ketchum, share views from a recent health equity panel event.

Working in the healthcare industry we strive to ensure health equity for all patients in the delivery of care, however there is still a long way to go and none more so than in the arena of clinical trials.

Ultimately, clinical trials provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. The lack of diversity in clinical trials, however, is a global challenge and has real implications for public health.

For us to make progress in this area, we need to understand how historical barriers to participation have amplified this inequity and will help us to address key issues now and improve representation in the future. This is a key moment for health equity and an opportunity to find meaningful, sustainable solutions.

Diversity not only includes ethnicity and hard-to-reach populations, but also gender, socioeconomic status, education, different backgrounds and cultural nuances. We need to enhance representation in clinical trials to ensure the safety and efficacy of treatments are accurate in the specific patient populations. This is a moral, scientific and medical issue, and it is an area of critical need for change.

Weight of history

Trust and tailored educational information are key to encouraging patients to participate in clinical trials. Unfortunately, historical studies of testing on different ethnic minority groups bred considerable mistrust and many wrongdoings occurred in the name of science.

Also, for some, there is a feeling that treatments are only tested on and accessible to a privileged population, and that those from minority backgrounds are just being used as ‘guinea pigs’, unsure if they are getting the actual treatment or placebo.

Even now, we have mistrust in the COVID-19 vaccine and trial participation. We have seen that the fear created based on a lack of understanding and misinformation, has impacted trial participation and even uptake by certain minority groups and under-represented communities.

The way we communicate with patients, their carers and family members needs to be better. So, how can we stop history repeating itself?

Cultural shift

We have seen many challenges magnified further due to the COVID pandemic, including the delays in screening and diagnosis across many conditions, the lack of mental health services and support, the cancer backlog and even the plight of informal unpaid carers taking on additional responsibilities. But, if COVID has taught us anything it is that we need to review current practice and adapt fast. This was the case in clinical trials and how they were conducted to ensure patients on trials could continue, modifying enrolment processes and how trials are run.

Accessibility is a large proportion of the challenge in clinical trial participation. Even when we are able to conduct more ethically sound research, it can still be done with the wrong patient populations or miss out a subgroup completely due to the lack of access.

Failure to reach these people may be due to cost, the approach to recruitment and enrolment, the preferences of the clinical enrolment managers and pharmaceutical companies or the fact the trial is being promoted via the wrong communication channels.

To be more inclusive, we need to change the way trials are conducted in terms of recruitment, but also potentially in how they are run. For example, running them in community settings and local hubs, rather than at larger clinical or hospital sites could provide more patients with greater access, reduce costs for patients and ease travel requirements, but also allow more people to participate – making them much more inclusive.

It can even be as niche as considering if the patients are on benefits in the UK. If they take part in a trial that they get paid for, they could be at risk of losing their benefit, affecting their income, so it’s too big a risk for them. So, the system has to understand what the implications are for all patients taking part from whatever group they come from.

At its most basic, we need to look at the people most affected by the condition and do more to get the right patients enrolled the first time around to make sure they benefit from the newest innovative treatments.

What we are starting to see now is also a US and Europe divide, with the FDA improving diversity, as well as publications becoming stricter on the demographic data submitted. Europe is lagging behind and regulatory bodies need to take note of what the FDA has done and how this is improving diversity and need to make expectations more specific.

We need to ensure, however, that changes are not made ‘tokenistically’, but intrinsically applied to make access fair and make trials truly representative in efficacy and safety by selecting the right and diverse patient population.

The study must be carefully considered: its protocols, how it is run and its outputs, as well as think about what areas it may be limited by in trial selection including socioeconomic status, gender, ethnicity and cultural backgrounds.

Engendering trust

There are several practical actions we can collaboratively take throughout the healthcare ecosystem to advance diversity and inclusion in clinical trials. Here we share some thoughts on what can be done to create inclusive educational communications programmes, informed campaigns and support resources.

• Get ‘boots on the ground’: We must build relationships and go into the communities to enrol patients and educate patients, carers and family members about clinical trials to dispel myths and misinformation, which causes so many barriers to uptake.
• Think about co-creation and collaboration within communities: We should be working with key community groups, religious groups, community leaders and even social influencers to develop tailored solutions and create a level of understanding and trust. It is twofold for communicators as we need to work with them to create the right communications approach and then implement it across the right channels, communities etc. There is also the need for peer-to-peer conversations and ‘people like me’ to engage the right audiences. This seems very simple, but will pave the way to greater representation.
• Trials need local intel: You may be recruiting in seven different countries, but the information to encourage participation needs to be tailored to incorporate cultural differences and the right communications approach and channels should be used for each. There isn’t a ‘one-size-fits-all’ approach that will enable inclusivity.
• Get the messages to the right people – not just the patient: Consider providing information and tailored communication not only for the patients, but also for their carer or family members to help explain how trials work, improve overall understanding and health literacy, and encourage participation in clinical trials. There are several ways to reach the patients and help them understand what is involved and expected, which may alleviate some of the mistrust and help to rebuild it.
• Use the best channels to engage the right audiences: Traditional channels such as social media, radio and Google ads, are easy to use in order to reach and target the patient populations, but there are other ways that will ensure more inclusivity of broader patient communities. Although it may be more expensive, this can help to secure more accurate trial outcomes.

Turning up the volume

This isn’t something that will change overnight and maybe right now we’re just moving the needle to build trust and increase understanding and that is ok as long as we continue to make progress and make this a priority.

We all have a pivotal role to play. It requires addressing issues on a global and local level by governments, pharmaceutical companies, patient advocacy groups and patient advocates, community leaders and representatives, academics, healthcare providers, healthcare professionals, technology experts and clinical research organisations.

This is clearly both significant and sensitive work, requiring the building of trust and confidence, establishing health literacy and developing programmes that engage voices – the voices that need to be heard.