A call to action: increasing patient diversity in clinical trials

In recent years we have seen a notable focus on patient diversity in clinical trials. This increased attention has not only highlighted the need for greater inclusion, but also the challenges faced by the pharma industry in tackling this issue.

Between 2008 and 2018, of the 230 clinical trials that led to cancer drug approvals by the Food and Drug Administration (FDA) in the US, diverse ethnicity was reported in fewer than two in three (63%). This lack of diversity is a major issue as studies have shown that different groups can respond to treatments in various ways.

Reasons for this lack of representation can be complicated, ranging from cultural barriers to a lack of knowledge of clinical trials. Conversations about effective inclusion are ongoing, but the majority so far remain ‘top level’, focusing on the overall shift that needs to occur to make a systemic difference. The reality is that this must be approached in a much more granular way, seeking out the investment of industry stakeholders to promote a commitment for change.

There is no easy or overnight solution to achieve greater patient diversity in clinical trials, but we cannot allow this to prevent us from addressing the issue.
A 360° approach is required, involving all those in clinical research. For us as individuals, change starts with small, repetitive, intentional action to help drive progress. Think about what you can do in your daily practice to enhance diversity knowledge. Are you a leader with influence in your organisation or are you responsible for speaking to patients or reviewing study design where diversity inclusion should be considered?
More widely, the FDA has issued guidance and continues to develop tools to support the industry, while sponsors are beginning to think about inclusivity within protocol design, especially in regard to eligibility of trial participants. With this in mind, more research sites are being selected in areas with diverse patient populations. This deliberate selection of sites is crucial as we know patients are drawn to individuals who share similar characteristics and typically trust their nearby hospitals, community leaders and clinics. Trusted vendors, like Innovative Trials, can support this activity, offering education and solutions to sites, clinical research organisations (CROs) and sponsors.

As experts in community engagement and recruiting under-represented groups for research, we frequently speak to our clients and sites who want to become more inclusive but are unsure about where to begin.

Most seem to understand the information we provide and appear motivated to push for change; however, while these conversations are easy for industry leaders with a focus on diversity, equity and inclusion, they are not as easy for those who are just listeners or readers.

One of the simplest and most effective ways to reach individuals within the industry is to provide them with quick facts about diversity and tools that either help them to educate, spread awareness, or highlight where an issue exists. Begin with those that you work closely with and educate the people around you to spark interest and conversation before expanding to larger groups of people and deploying solutions to increase the momentum for change in the diversity space.

From our experience in the field, we know that change happens with repetitive actions. There is not a ‘one-size-fits-all’ approach. We deploy numerous solutions to bring intentional awareness, such as through coaching calls with sites exploring diversity-focused recruitment opportunities, site demographics and accessibility, education on diversity and minority inclusion, workshops and advocacy group interactions.

There will always be unique challenges, so we work closely to provide bespoke multidimensional solutions. Most importantly, we ensure our tactics are easy to implement, relevant and impactful.

Above all, we at Innovative Trials believe in a ‘boots-on-the-ground’ approach to develop and maintain relationships with community stakeholders in diverse communities to provide under-represented groups with the same opportunities to participate in clinical trials as others.

The answer to tackling low rates of patient diversity in clinical trials is to start small.

Diversity will continue to become increasingly significant and we, as an industry and as individuals, must be a driving force to create change and close the gap that currently exists. Intentional action is necessary; this may seem difficult at first but does get easier the more it is practised. We have a duty to make clinical trials more inclusive by targeting and connecting with diverse communities.

Do you need support to engage and recruit diverse patient populations for your clinical research studies? Find out more about the services we offer and how our practical and community-focused approaches deliver results at https://innovativetrials.com/

‘Reasons for a lack of diversity can be complicated, ranging from cultural barriers to a lack of knowledge of clinical trials’