Abstract B71: State legislative efforts to address barriers to racial and ethnic minorities' participation in cancer clinical trials

Clinical research is a critical resource for the development of new cancer prevention, diagnosis, and treatment techniques that could become new standards of care. In order for the results of clinical research to be generalizable to the broader population, research participants must reflect demographic factors of the population, including race/ethnicity, gender, and age. Underrepresentation of minorities in clinical research persists. A 2005 report by the Agency for Healthcare Research and Quality (AHRQ) found that racial and ethnic minorities, adolescents, the elderly, rural populations and individuals of low socioeconomic status are all underrepresented in clinical trials funded by the National Cancer Institute (NCI) and identified more than 100 barriers to recruiting underrepresented populations to cancer clinical trials. Commonly reported barriers were un or underinsurance and a lack of culturally and linguistically competent health professionals. In an attempt to remove barriers faced by underrepresented populations, patient navigator (PN) programs have been created and some states have mandated health insurance coverage for clinical trials. Coverage mandated through Medicaid may be particularly beneficial to recruitment of the otherwise uninsured.

We analyzed state-level legislative data from the NCI's State Cancer Legislative Database (SCLD) to identify statutes (enacted as of September 30, 2008) related to insurance coverage for cancer clinical treatment or prevention trials, access to patient navigator programs, translation of treatment information, and cultural and language competency training for healthcare workers.

Preliminary data from SCLD reveal that fewer than 40 percent of states statutorily mandate some level of insurance coverage for clinical trials. Fewer than 10 percent mandate that Medicaid or other public insurance cover the costs associated with cancer clinical trials. While Federal legislation has been enacted to fund PN demonstration projects, there is a paucity of state-level policy and legislation; few states have codified guidelines published by NIH supporting the inclusion of women and minorities in clinical trials or introduced legislation calling for PNs. Given the substantial cancer burden borne by minorities, it is apparent that policies need to be developed to address the barriers that preclude broad access to trials and broad applicability of their results. Next steps would involve linking SCLD state policy data with sociodemographic and state-of-residence data for cancer clinical trials participation.

Agency for Healthcare Research and Quality. Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. June 2005. Available online at www.ahrq.gov/downloads/pub/evidence/pdf/recruitcantrials/recruit.pdf.