PCR115 Learnings Associated with Implementing Qualitative Exit Interviews in Two Placebo-Controlled Clinical Trials

Embedded or exit clinical trial interviews are increasingly being used, and recommended by regulators, to explore patients’ real-world experience of changes observed understand the impact these in daily life. Such qualitative data contextualises results can inform evaluation meaningful change on endpoints. To achieve successful implementation interviews, robust operational processes need be place ensure integrity is upheld. Exit were conducted with study partners autistic people as sub-studies two multi-center, randomized, double-blind, placebo-controlled trials: A (Phase 2) children/adolescents aged 5 17 years; B 3) adults. The intention was interview approximately 25% intent-to-treat (ITT) population, recruited a first come served basis upon exit. Ideal quotas set for age, but recruitment analysis blinded treatment allocation (proportional representation expected chance). Following analysis, unblinded reviewed. population (EIP) 27% ITT (86/308) A; 12% (41/320) (ended early based pre-planned futility analysis), from 34 sites (1 country) 19 (4 countries) B. EIP highly comparable assessed demographic descriptive characteristics, including endpoints allocation. Positive engagement all vendor’s access monitoring platform facilitated recruitment. However, learnings around timing ethical approval, more consistent site engagement, clearer communication partners’ willingness could have led fewer lost follow-up timelier conduct after end treatment. These studies demonstrate using provide important improving considerations implementing alongside trials.