Background/Purpose: Although SLE disproportionately affects minority racial groups, they are significantly under-represented in clinical trials. This may lead to false, underpowered conclusions in race-based sub-group analyses. We conducted focus groups to evaluate perceptions of clinical trial participation by diverse lupus patients. The analysis was guided by the Theory of Planned Behavior, a construct that behavior is determined by attitudes (behavioral beliefs), the opinions of others (normative beliefs), and perceptions about the level of control (control beliefs).

Methods: A qualitative research design was employed, using three 90-minute focus groups with 23 patients aged 21-72 years, enriched for minority participants (15/23; 65%). A trained moderator asked open-ended questions about clinical trial participation including: advantages and disadvantages (behavioral beliefs), person(s) who would approve or disapprove (normative beliefs), and enhancers and barriers (control beliefs). Discussions were recorded, transcribed, and analyzed to identify emerging themes.

Results: Patient characteristics are summarized in Table 1. Initial interrater reliability was high (93%), and the discrepancies were resolved through discussion. Perceived advantages to trial participation included a better understanding of SLE, benefit for current and future patients, and access to otherwise costly or unavailable care and medication. Disadvantages included concerns about unknown aspects (placebo receipt and side effects), information burden (jargon, lengthy and redundant forms that are difficult to process), letdown (exclusion from trials, lack of efficacy, withdrawal of effective therapy), issues with life and health balance (time away and travel), inadequate feedback, and additional procedures in trials. Although some patients engaged in discussions about research participation with approving or disapproving family, friends, or co-workers, self-approval superseded external approval. Comorbidities and costs were identified as barriers. Factors identified that would ease participation in a trial included flexibility in time and scheduling, advanced notice of studies for contemplation and arrangements (childcare, work), streamlined forms with the option of electronic technology, post-study feedback, and the hope of SLE improvement (personal, drug discovery, cure).

Conclusion: Knowledge about potential benefits of trial participation was high, and minority patients appeared to be equally confident as others in making their own informed decisions. Disadvantages and barriers to clinical trial participation identified by an SLE population enriched for minority patients include the burden of forms, and difficulties with travel, childcare, and work. These suggest a major impact from behavioral and control beliefs which will need to be considered during trial design and implementation.