Patient perspectives on clinical trial participation for novel advanced therapies: a focus group study in systemic...

To identify barriers and facilitators in systemic lupus erythematosus (SLE) regarding participation in clinical trials for novel/advanced agents, such as cellular therapies. Adults from our SLE research registry participated in 1-hour virtual focus groups concerning their perspectives on clinical trials for novel/advanced SLE therapies. Sessions, facilitated by trained moderators, were recorded and transcribed. An inductive thematic analysis approach was used to code the data and generate themes/sub-themes. Nineteen patients participated in four focus groups (two in English, two in French). The mean age (range) was 50.0 (21–77) years and mean disease duration was 21.4 years. Most (90%) participants were female and 79% (15/19) were White, with the remainder being Black, Asian, and Hispanic. Few had previously participated in a clinical trial. Six major themes emerged: two barriers and four 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 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 counsellors, peer support, and close medical follow-up were strong facilitators of participation. 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.