A selling point of decentralised clinical trials (DCT) is that by easing logistical and geographical obstacles, a wider variety of patients can participate in studies, thus assisting in improving diversity.
Yet a study released on May 5 is sounding the alarm that it is still unclear if DCT will significantly improve participant diversity. In fact, trials with a digital element are at risk of unintendedly overfocusing on one single element of inclusion, such as race, and leaving other factors, like education or gender, behind.
Even then, there is an inherit hesitancy among minority subgroups related to structural racism even if there is work done in easing geographic inconvenience, researchers say. And these challenges are unlikely to be overcome by the technological approach alone.
Education, gender clinical trial diversity needs to be addressed
In the study published on the digital magazine Nature Portfolio Journal, study authors collected evidence pointing to opportunities and challenges in improving patient inclusivity and diversity when adopting and adapting DCT approaches. Researchers highlight how decentralisation can target certain cohorts and diversify patient populations. However, they argue that by simply using more technology driven DCT approaches in clinical trials, inclusion pitfalls may not be completely avoided.
Authors explain that clinical trials measure inclusivity and diversity in a unidimensional way by reporting percentages of a chosen category, such as gender, sex, disability, and so on. And focusing on one category can cause imbalances in others. For example, online recruitment campaigns zeroing in on racially diverse populations result in disproportionate enrolment of females, people with higher education levels, and with higher income.
Researchers found that DCTs are not immune regarding overrepresentation of racial subpopulation of patients. In a Covid-19 trial testing the efficacy of hydroxychloroquine, 821 participants were primarily recruited via social media and later followed-up using online surveys. While the decentralised study succeeded on gender parity (51.6% female), Black participants were under-represented and Asian participants were overrepresented when compared to other populations. This is in context of Black and Latino communities being significantly impacted by Covid-19.
Tech divide among potential participants
In an exclusive data-driven analysis by Clinical Trials Arena, uptake of DCT approaches, including tech-driven ones, are expected to further increase in 2022, with our latest update noting telemedicine had a notable utility uptick in the first three months of this year.
Researchers nevertheless noted digital divide can be seen as one of the most significant barriers among potential trial participants. Access to internet or even smartphones, especially in older, poorer, less urban, or in minority ethnic groups, is less prominent.
Delivering medicine to trial participants directly can be more of a challenge than as a solution from obstacles in pharmacy collection, researchers say. Clinical Trials Arena reported on February 10 about the slow uptake, as well as regulatory framework and logistical challenges, regarding remote drug delivery in clinical trials.
The study confirms how DCT can allow for swift enrolment. Researchers compared recruitment features between DCTs and traditional study approaches. They found that DCTs were enrolled from an average of 40 states in the US in four months, compared with traditional trials that spent 15.9 months focussing on one state.