Abstract
Background: Recruiting and retaining participants for clinical trials, particularly women and ethnic minorities, are challenging. Few studies, however, examine gender and ethnic differences in research processes. Such information is important for findings to adequately represent the available population.
Objective: The study aim was to examine study recruitment processes (referral, eligibility, consent/enrollment) and study retention (completion) for gender and ethnic differences.
Methods: A descriptive comparative analysis of data from 2 randomized clinical trials focused on cancer outpatients with pain and/or fatigue. A computerized ResearchTracking software allowed documentation of recruitment and retention effort outcomes.
Results: Among the 1464 referred patients, 612 (42%) were eligible for study participation. Lack of ongoing care at the study settings and lack of English skills were the main reasons for ineligibility. There were no gender differences in consent/enrollment or completion rates. Ethnic minority patients were represented proportionally to the available population (13%) and were equally willing to consent/enroll and complete both studies as their white counterparts, if they were eligible.
Conclusions: Specific strategies to target language eligibility barriers are necessary to increase minority participation.
Implications for Practice: Future studies could include audio-aided tools in their native language to help recruit patients with limited English skills, if the study tools can be validly translated into other languages and are equivalent to English versions. Efforts to educate and garner support of providers could improve enrollment of patients in cancer studies, especially in studies of audio- or video-recorded patient-provider interaction.