Key ways to humanize trial design through patient and site engagement strategies

Purposeful focus on protocol burden assessments by race and ethnicity

To strengthen the R&D industry’s commitment to sufficient representation in clinical trials among the traditionally disadvantaged, it is essential to abandon assumptions about lack of will or that focusing on diversity adds time and cost.

Together with patient-centered survey insights, virtual or face-to-face focus groups, real-world data, etc., sponsors can apply advanced analytics to assess patient burden based on study design aspects. With analytics, protocol elements can be scored to quantify patient burden by race and ethnicity to identify and engage patient subpopulations. Sponsors can assess whether protocols require the expected level of burden compared to protocols for a similar phase, therapeutic area, disease, etc.

These nuances in study participation motivators can indicate how well a study design will work for certain subpopulations. For example, if a study requires an overnight stay or longer site visits, does that influence the willingness of Black/African American patients to participate compared to other communities (eg, Asian, Hispanic, or Caucasian)? Recent survey results show that there are subtle differences and that length of visits or overnight stays did not influence Black/African American respondents’ willingness to enroll as much as other groups.

As sponsors calculate and compare protocol assignments, considering the perspectives of diverse populations during study planning can help validate the study design or more quickly identify adjustments needed to increase potential enrollment among different populations.