According to US Food and Drug Administration (FDA) data, in 2020, 75% of trial participants were white, 11% were Hispanic, 8% were black and 6% were Asian.
As the statistics indicate, historically, clinical trials have lacked representation from certain populations. This includes underrepresented racial and ethnic groups, but also individuals with disabilities, older adults and LGBTQIA+ communities.
Why is this problematic? Participants are critical to the success of a clinical trial by helping to bring new treatments to those who need them around the world. However, the participant population in a trial should reflect the broader population that will use the treatment. If trials predominantly include one demographic group, the results may not apply equally to others. As such, all races, ages, genders and socio-economic backgrounds need to be appropriately represented in trials to truly ensure efficacy and safety.
The challenge of enrolling diverse populations
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.
Read the article in full here.