Maximizing the diversity of participants in a phase II clinical trial of optical technologies to detect cervical neoplasia.

INTRODUCTION

We compare the racial and ethnic demographics of our participants with the populations where our clinics are located (Texas and British Columbia) and investigate the reasons cited for participation.

METHODS

We compared the distribution of participants by race/ethnicity to numbers from the 2000 United States Census and the 2001 Census of Canada. Each participant recorded her reasons for enrolling in the trial in her own words. This information was then categorized for analysis. For participants who provided more than one reason for participation, their responses were weighted accordingly to sum 100% for each race. All analyses were performed using SPSS v12.0 (SPSS, Chicago).

RESULTS

In all, 1850 women participated in the study. Except for Asians in the Vancouver population and Native Americans in both populations, all minorities were recruited in proportions in excess of their respective proportions in the general population. Distinct differences in the reasons for participating between sites were noted. Houston patients were more likely to cite concern for one's own health as a reason for participating. On the other hand, Vancouver patients were more likely to cite helping others. This trend was found in both the screening and diagnostic populations.

CONCLUSIONS

We attribute our success in recruiting minorities to community outreach, our multicultural staff, and efforts to provide uniform care at all sites.