One size does not fit all: Clinical trial investigator perspectives of disparities in racial/ethnic minority participation in oncology clinical trials.

108 Background: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients remain underrepresented in oncology clinical trials. Little is known about clinical trial investigator perspectives of REM participation in clinical trials. To our knowledge no published studies exist assessing differences in investigator perspectives based on their primary role in the clinical trial process. We hypothesized that differences exist in investigator perspectives regarding REM participation in oncology clinical trials based on having a more design-oriented (principal (PI)/co-investigator (co-I)) or recruitment-oriented role (sub-investigator (sub-I)). Methods: We conducted a cross-sectional, anonymous, pilot survey of oncology clinical trial investigators at an academic center. Over 5 weeks, 107 individuals received a survey assessing 6 domains about disparities in REM participation in clinical trials, including knowledge, attitudes, and prior training. Modified, previously validated items were used if possible. We performed a subset analysis of mid- and late-career investigators (>/= 10 years of experience) comparing those who opened at least 1 clinical trial in the past year as PI or co-I to those who did not (sub-I). Results: There were 60 respondents (56% response rate). Average time as a clinical trialist was 14 years (2-40). Average number of trials opened in the last year as PI/co-I was 4 (1-30). Among all respondents, 83% strongly agreed disparities exist in REM clinical trial participation and that lack of diversity is problematic (75%). Notably, 45% agreed this is a problem they cannot directly address. Among mid- and late-career investigators, those who opened at least 1 trial as PI/co-I were more likely to have received training about barriers/facilitators (OR=3.56; 95% CI=1.05, 12.04; p=.04) to REM clinical trial participation and about strategies for improving participation (OR=3.75; 95% CI=1.06, 13.29; p=.04). Despite this, they were more likely to endorse wanting help to improve in this area (OR=4.95; 95% CI=1.17, 21.02; p=.03). Conclusions: Our results suggest there is awareness among clinical trial investigators of disparities in REM clinical trial participation, but investigators do not feel they can directly address these. Investigators who are more involved in clinical trial design are more likely to want help to improve their ability to address disparities in REM trial participation despite being more likely to have received prior training on the topic. Our findings suggest training alone is inadequate support for investigators involved in designing clinical trials. More studies eliciting the needs of investigators with varying roles in the clinical trial process are needed to inform targeted interventions to enhance investigators’ self-efficacy for improving REM participation in clinical trials.