Perspectives on Clinical Trial Participation for Novel Advanced Therapies: A Focus Group Study in Systemic Lupus Erythematosus

Objectives To identify barriers and facilitators perceived by people with SLE regarding participation in clinical trials for novel/advanced agents, such as cellular therapies.

Methods Adults from our SLE research cohort were invited to participate in 1-hour virtual focus groups concerning their perspectives on clinical trials for novel/advanced SLE therapies. Sessions, facilitated by trained moderators using standardized questions, were recorded and transcribed. An inductive thematic analysis approach was used to code the data and generate themes/sub-themes.

Results Nineteen patients participated in 4 focus groups (2 in English, 2 in French). The mean age (range) was 50.0 (21-77) years, and mean disease duration was 21.4 years. Most (90%) of participants were female and 79% (15/19) were White, with the remainder being Black, Asian, and Hispanic. Six major themes emerged: 2 barriers and 4 facilitators to trial participation. The first barrier was time and logistical constraints, such as employment and travel. The second was risk aversion, including subthemes of concerns of SLE flare, drug side effects and early-phase trials. Facilitators included receiving clear, detailed clinical trial information. Disease instability was another driver, making patients increasingly willing to accept elevated health risks, time commitment and/or logistical challenges. Desire to support the lupus community was also an important factor. Finally, access in clinical trials to mental health counselors, peer support, and close medical follow-up were strong facilitators of participation.

Conclusion We identified potential barriers and facilitators/driving factors for SLE patients regarding clinical trial participation, which are particularly relevant for novel/advanced agents like cellular therapies.