DIVERSITY, EQUITY & INCLUSION


The results of this empirical study demonstrate an association between the inclusion of DCT solutions in clinical trials and the racial and ethnic diversity of patients enrolled in these clinical trials. However, in this initial study, this association was not uniform across all DCT solutions used. Specifically, the use of local labs was associated with a lower percentage of white patients enrolled, and the use of virtual visits and televisits was associated with a lower percentage of enrolled patients who identified as Black or of African Descent. Virtual visits and televisits, in particular,


require the use of technology and infrastructure (e.g., desktop or laptop computer or tablet, reliable, high-speed internet connectivity and computing power) that may not be available to a disproportionate number of people within select — and likely underserved — patient communities. The use of mobile and wearable devices showed no significant differences in the demographic distribution of enrolled participants. This may be due, in part, to varying levels of comfort among study volunteers by demographic subgroup with respect to the use of mobile technologies especially as a replacement for in-person interactions. Clinical trials that included the use of local labs had a significantly lower percentage of white patients than those which did not offer this DCT solution. Because no other single racial demographic showed a significant increase, it can be assumed the increase was distributed among all of the non-white racial demographics (except multiracial), resulting in a more diverse participant sample. This finding is partially explained by studies in the literature that have explored the relationship between participation convenience and willingness to enroll. The location of the research center has been shown to be one of the most important factors influencing a patient’s decision to participate in a clinical trial and a majority of patients are unwilling to enroll in trials that require them to travel more than 20 miles (Andersen et al, 2018). The use of local labs in clinical trials adds convenience and reduces travel burden. These benefits may improve the representativeness of trials by not discouraging patients with


The very low prevalence of home visits in our dataset may be explained by the high relative cost and the difficulty scheduling and arranging for home health care professionals to visit participants’ homes


limited access to personal and public transportation options. which may disproportionately impact patients of color and other marginalised groups. The very low prevalence of home visits in


our dataset may be explained by the high relative cost and the difficulty scheduling and arranging for home health care professionals to visit participants’ homes. There are a several study limitations to mention: This initial study is based on a relatively small convenience sample of clinical trials that provided data on the use of DCT solutions. In addition, further limiting our study sample size, demographic data were available for most of the Phase II and Phase III clinical trials, but not all of them. Our analysis also only looked at the general distribution by demographic subgroup in clinical trials without taking disease prevalence into account. Demographic differences may be due to lower or higher disease-specific prevalence rates among demographic subgroups, not due to the use (or lack thereof) of DCT solutions. Future research will look to increase sample size, and to control for disease prevalence by demographic subgroup. Future research will also look to understand the impact of DCT solutions use on other measures of patient diversity including social determinants of health. The results of this initial study provide


evidence supporting the value proposition that DCT use improves racial and ethnic diversity in clinical trials, but the improvement is specific to individual DCT solutions deployed.


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