Driving diversity in clinical research

There are many potential reasons why ensuring diversity among clinical trial participants is challenging, including from the perspective of both sites and participants.

Site view
While many countries have regulations or guidance related to diverse clinical trial enrolment, this does not always translate into meeting diversity goals. For instance, according to the Society for Clinical Research Sites (SCRS) 2023 Site Landscape Survey, nearly 40% of site respondents indicated that they are either not aware of their country’s diversity regulation or don’t know what it entails.

Along with awareness about diversity regulations, many sites feel that they don’t have the resources needed to recruit diverse populations. In fact, according to the SCRS, nearly 60% of sites indicated that they don’t have the appropriate support regarding diverse recruitment.

Whether incorporating additional diversity-related budget line items, implementing support for community engagement or providing further educational resources, there are steps that can be taken to better assist sites in meeting diversity enrolment goals.

Participant view
According to the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2023 Global Perceptions and Insights Survey, when asked ‘in general, when discussing treatment or medication options with your doctor, how often do you consider clinical research studies as an option’, only 34% indicated ‘very’ or ‘somewhat often’.  Why are we not seeing more consideration of clinical trials?

From lack of trust or education about clinical research to cost, time and effort, there are many potential hurdles or negative perceptions that prevent prospective patients from participating in trials and these hurdles can disproportionately affect certain subgroups of the population.

Related to trust, CISCRP’s survey showed that ‘black respondents’ trust in pharmaceutical companies was more likely to be increased by knowing that the company employed staff that was diverse and that the company included a diverse set of participants in their clinical trials’.

Hispanic respondents were also more likely to show increased trust in pharmaceutical companies, knowing that the company employed staff that was diverse. Therefore, proving that diversity is being implemented in trials has been shown to increase trust among underrepresented groups.

In addition to trust, financial and logistical impacts are often cited as the top deterrents from participating in studies. In fact, according to CISCRP, when thinking about the logistics of the clinical trial, ‘potential costs and reimbursements’ along with the ‘physical location of the research study centre’ (distance from home or work) were two of the top three concerns.

For example, clinical trial research sites are often located in major cities. If patients don’t live in close proximity to the city or have a reliable means of transportation, getting to the clinic can be a major hurdle. Additionally, the time commitment required to participate in a trial can be significant, often necessitating participants to take extended time off from work. The costs related to transportation, lost wages, childcare and more are simply not sustainable and, again, disproportionately impact populations that are not equally represented in clinical research.

While technology has been a cornerstone in clinical research for years, it was the pandemic that fast-tracked the use of technology to support remote trial activity. There has been some concern about the increased use of technology, as not everyone uses or is comfortable with technology to the same extent. According to CISCRP, 95% of respondents to their survey indicated that they ‘always’ or ‘sometimes’ use a smartphone. As such, the increased use of technology has proved to be a viable solution to keep trials on track and enable participants to continue receiving care during the pandemic and beyond.

As the world and the industry rebounded, trial activity began to return to the clinical research sites; however, the benefits of the technology remained. The idea of ‘flexibility’ became a top focus, where some activities could be completed on site and other tasks completed remotely.

Offering flexibility is critical when it comes to addressing the innate barriers that stand in the way of trial participation, especially for certain populations. Some of the key challenges faced that technology continues to alleviate are financial, logistical, time and communication-related:

• If HCPs share important, easily digestible information and study-related resources in real time with the participant and their caregivers, they will feel more comfortable and more informed about the trial and what is expected
• If HCPs can arrange pre-paid transport for participants with the click of a button, the transportation hurdle and out-of-pocket cost are eliminated, supporting ‘financial neutrality’

‘Proving that diversity is being implemented in trials has been shown to increase trust among underrepresented groups’

• If HCPs can enable participants to complete eConsent, a telehealth visit or required survey, or eDiary from the comfort of their homes, this results in less time away from work, family and personal commitments
• If HCPs can automatically trigger a small payment to the participants for completing a required task or reimburse them for out-of-pocket expenses in real time and via a participant-preferred method (eg, card, bank transfer, direct deposit, digital payment), they will feel more appreciated and will be more likely to stay compliant and enrolled in the trial.

In summary, diversity in clinical research has been a hot topic and for good reason. Enrolling diverse participant groups in clinical studies ensures treatments are effective and safe for the broader population that treatments are intended for. In order to do this, we need to identify and understand the obstacles that stand in the way of achieving more diverse enrolment.

Technology has been and continues to be a critical component in supporting patient enrolment, engagement and convenience, especially to drive diversity in clinical research. This includes simplifying and easing many of the burdens faced by participants and prospective participants, such as financial, logistical and educational barriers. However, we must keep the conversations alive, gain feedback from those who face these burdens, and continue to innovate and drive our industry forward, making clinical trials more accessible for all.

Kim Boericke is Chief Operating Officer at THREAD and Tanya Kogan is Senior Product Manager, Greenphire