All training materials and consultation were provided in Mandarin. A custom patient-simulation video was created with a Mandarin-speaking clinician interviewing a Mandarin-speaking patient. Additionally, all communication from our study management team was likewise directed through our US-based Mandarin-speaking project management team.
A suicidal event was recorded during a trial, requiring additional focused training in suicidality assessment in the study population. Training on outcomes measuring suicidality was conducted at the start of the trial, and there was no indication that the suicide was related to problems with how suicidality was assessed and tracked in the trial. However, it was determined by the Sponsor that all sites would benefit from additional training that focused on this aspect of assessment. The response had to be comprehensive and deployed quickly.
Focused, specialized training: With 2-week lead time, our scientific team conducted a review of the training on suicidality assessments provided for this trial and created a self-paced, interactive training module for this topic, including simulation components that were deployed to all study sites. We created a posttest component that allowed our team to track compliance with the new training requirement, as well as measure and report on investigator performance.