Retention of under-served women in clinical trials: a focus group study.

More information is needed to understand how women view their participation in clinical trials. As part of the formative evaluation phase of a 4-year National Cancer Institute funded study, researchers associated with the "Community Retention Intervention Study" (CRIS) conducted focus groups to identify additional data on the underlying issues regarding the retention and compliance of under-served women in clinical trials. Six focus groups were conducted: 3 were age-based, and 3 involved participants of the Women's Health Initiative (WHI) clinical trial component in Birmingham, Alabama. A total of 62 women, between 18 and 87 years of age, participated in the sessions: 79% were African-American and 52% reported incomes below dollar 20,000. The qualitative data analysis revealed that women were more inclined to participate in a clinical trial if they, or a family member, would benefit. Non-compliance with study protocols was generally a result of complications or unwanted side effects of treatments. Focus group data were used to develop retention and compliance strategies for the CRIS study. Findings suggest that focus group data can be used effectively to develop retention and compliance strategies specific to under-served women.