Acknowledging and including diversity in clinical trials brings new approaches and the potential of more effective treatments for patients, says Labcorp
The pandemic has emphasised the huge importance of diversity in effective drug development. Labcorp has, however, long recognised the value of diversity both within its company culture and in activating innovative solutions to engage diverse communities in clinical trials.
Supporting a diverse workforce is core to the company’s ability to innovate and meet customer needs. Every person has a critical role in delivering the company’s mission of improving health and improving lives, and it is this foundational approach that it builds on as it implements strategies focused on diversity in clinical trials.
Labcorp’s company-wide diversity and inclusion strategy aligns to three overarching pillars: empowering inclusive leadership; developing and sustaining a diverse talent pipeline, plus creating an environment for engagement across the business and within the diverse communities it serves as both a diagnostic laboratory and a contract research organisation (CRO).
One vital area of engagement within these communities is a focus on increasing diversity in clinical trials. The importance, and challenges, of enrolling diverse patient groups into clinical trials are well known. At the same time, while approaches to changing this paradigm have been discussed extensively, there is limited evidence to date of a notable increase in diverse trial participation. The pandemic magnified the logistical barriers diverse populations face, and further highlighted the need to take actions to positively impact both patients’ lives and drug development.
Labcorp has long realised the benefits of not just working with the existing investigator pool and their patients, but also directly raising awareness of clinical trial participation amongst the patients it serves day to day through its diagnostics business. This investment in these communities has been in place since well before the pandemic. This means that the company can directly engage an ever-growing resource of people (currently over 50 million) across all communities and directly invite them to participate in clinical trials. These are people who might not otherwise have had the chance to consider such an opportunity.
Of course, simply being able to contact people is not enough, so the team also focuses on engagement at a community level to overcome historical precedents and improve levels of trust in clinical research. It is also working to increase the involvement of doctors as investigators from these communities.
An established and ongoing collaboration with Circuit Clinical – a US organisation that facilitates finding, understanding and choosing clinical research as a care option – gives Labcorp-supported doctors the opportunity to become investigators. This approach brings research to diverse patients in their local setting, with doctors they know, overcoming two of the key barriers to diversity and inclusion.
The firm then overlays its approach to decentralised trials, enabling more patient flexibility and less reliance on clinical trial sites. For example, Labcorp is leveraging its network of patient service centres (PSCs) across the United States to support blood tests close to home or work. This reduces the need for travel and/or time off work, removing potential conflicts with an individual’s life and responsibilities, which can also be key barriers to enrolment of diverse populations.
Recognition of diversity
The last few years have seen greater recognition of the importance of diversity in clinical trials. This has attracted investment and new operational approaches to support patient engagement and enablement from the industry. For example, there is now much more focus on using data to support identification of investigators who work with diverse communities.
Labcorp’s collaboration with Circuit Clinical recognises that enabling doctors who serve diverse communities to become investigators opens up the potential for clinical trials to be conducted near populations who might otherwise struggle to have access.
The importance of long-term community engagement has also come to the fore as a key enabler of tactical study enrolment. Of course, it is not just about access, but also about cultural attitudes towards trials. Historical events still shape current perceptions about trial participation, it seems, and education regarding current trials is therefore key. As a result of applying such insights, the first case studies of diverse enrolment are showing promise, largely within the US. There is much more that can and must be done to expand on these initiatives and incorporate a more global approach, but these studies give a glimpse of the future.
Challenges facing wider society
The challenges of diversity in clinical trials in many ways mirror those of diversity in healthcare and health equity overall. For example, it is known that some demographic groups have less engagement or access to healthcare, and consequentially less opportunity to participate in clinical trials. In addition, some demographic groups are more impacted by specific diseases. Consider the disproportionate impact that prostate cancer has on African American men, as an example. This combination of factors highlights the opportunity to increase the enrolment of patient groups that are more representative of the patients who could ultimately benefit from the treatment.
Recognising this, increasing engagement in clinical trials has the potential to support engagement in healthcare generally, and vice versa.
Embracing diversity to transform drug development
Embracing diversity also supports the engagement of broader groups of patients and recruitment from a larger patient pool. It will be interesting to see if this has a positive or negative impact on overall study timelines, specifically recruitment periods, over time. Moreover, it has the potential to accelerate the transition of research, from traditional investigator sites using traditional methods, to a much broader investigator base serving a broader population using more patient-centric approaches. This can only further support drug development and the concept of research as a treatment option.
Positive difference to operations
To minimise challenges for the patient, Labcorp takes the operational approach of supporting research in the setting where the patient is receiving their care, and that is most familiar to them. This is a core part of its strategy to enable diversity in patient enrolment.
The industry needs to see this as an evolution, not a revolution. Every stakeholder must ask itself:
- Is the design of the trial appropriate for diverse populations?
- Are we inadvertently introducing unconscious bias in our assumptions about what patients will tolerate?
- Are we doing enough to understand the nuances of the individual demographics?
- Are we doing enough to reach poorly engaged communities?
- Are we listening to the personal needs and medical needs of patients, and seeking to accommodate those in our designs?
- Are we doing enough to challenge misconceptions about trials?
Through this multifaceted approach, Labcorp continues to expand its mission to improve health and improve lives for everyone.