Clinical trial recruitment in rural South Carolina: a comparison of investigators' perceptions and potential participant eligibility.

INTRODUCTION Participation in clinical trial (CT) research can help decrease health disparities in rural communities. The purpose of this study was to examine the perceptions of principal investigators (PIs) regarding CT participation barriers and recruitment efforts in rural South Carolina, USA and to assess the actual pool of potential CT participants in rural and urban South Carolina. The ultimate goal was to evaluate the fit between PIs' perceptions and the pool of eligible participants in rural South Carolina. METHODS An online survey was conducted with 119 CT PIs from South Carolina's five main academic medical centers located in urban areas of the state, for a response rate of 31%. Secondary data analyses were also conducted using data from government health insurance plans, including the 2009 South Carolina Medicaid, the 2009 State Health Plan (SHP) data, and census data from the 2005-2009 American Community Survey (ACS). Both parametric and non-parametric statistics were used to analyze survey and secondary data. RESULTS Principal investigators perceived greater recruitment barriers in rural areas than in the general population. They indicated having difficulty finding CT participants in rural areas compared to the general population (t= -2.985, p=0.004). Rural residents were significantly more likely to be perceived as lacking knowledge and understanding about CT than the general public (t= -2.105, p=0.038), having significantly lower literacy than the general public (t= -2.058, p=0.043), lacking information about available CTs (t= -2.913, p=0.005), and having limited accessibility to trial sites compared to the general population (t= -4.380, p=0.000). Patients' insurance coverage, however, was not found to be a significant barrier for CT participation (t=0.418, p=0.677). Secondary data variables were aligned with these barriers. Data revealed that rural residents have slightly lower educational attainment than urban citizens >t=5.384, p=0.000), and more people live below poverty level in rural areas (23%) than in urban areas (15%) (t=4.86, p=0.000). The secondary data analyses also showed that the majority of rural citizens covered by the SHP and Medicaid are eligible for CTs. ACS data revealed that 75% of people in rural areas meet one or more basic eligibility requirements to participate in CTs compared to 83% in urban areas. CONCLUSIONS Some important barriers hinder CT enrollment of rural participants, such as accessibility to trial sites, poverty, lack of knowledge about CTs, among others. Data suggested that insurance coverage, however, is not a barrier to CT participation. Although CT PIs are correct in considering these barriers in rural areas, there still exists a large pool of potentially eligible CT participants in rural South Carolina. PIs, who were recruited from urban academic medical centers, may therefore be perpetuating unhelpful rural myths about CT eligibility in rural communities. Despite their remote locations, rural citizens should take part in medical research. Greater communication between PIs and rural participants and better education of PIs on communication strategies are needed to enhance CT participation in rural South Carolina.