TRIALS AND TRIBULATIONS: DIVERSITY AND INCLUSION IN PANCREATIC DUCTAL ADENOCARCINOMA CLINICAL TRIALS
Kelly M. Herremans*1, Andrea N. Riner1, Steven J. Hughes1, Jose G. Trevino2
1University of Florida College of Medicine, Gainesville, FL; 2Virginia Commonwealth University Medical Center, Richmond, VA
Background: Pancreatic ductal adenocarcinoma (PDAC) remains a deadly malignancy with an estimated overall 5-year survival rate of 9%. Disparities in PDAC prevalence, treatment and mortality disproportionally affect underrepresented minorities (URMs). These disparities are poorly understood and are unaccounted for by socioeconomic means alone, with divergent tumor biology in different racial/ethnic groups potentially driving observed inequities. This study investigates the lack of diversity in PDAC clinical trial participation.
Methods: Clinical trial data was obtained through ClinicalTrials.gov. PDAC clinical trials with results were included. Trial data and participant demographics were obtained through reported study results and associated publications.
Results: 207 PDAC clinical trials including 13,448 participants were analyzed. Gender was reported in 99% of trials whereas race and ethnicity were reported in only 45.9% and 34.2% of trials, respectively. Hispanics (5.2%), Blacks (6.4%), and American-Indian or Alaska Natives (0.1%) were notably underrepresented in PDAC clinical trials. Whites (83.4%) were overrepresented while Asians (6.1%) were equivalent to national population statistics. Black participants were less likely to be included in phase 3 trials (2.7%) than phase 1 (9.9%) and phase 2 (9.8%) trials. Participants were 44.6% female and 55.4% male.
Conclusions: PDAC clinical trials do not adequately report or include URMs, which represent a significant portion of the US population. Black PDAC patients are more likely to be enrolled in early phase trials on safety and efficacy rather than therapeutic standard of care. A better understanding of biologic responses in diverse racial/ethnic populations, through the inclusion of URMs in clinical trials, is critical to reducing healthcare disparities and improving patient outcomes.
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