Abstract
OBJECTIVES: To gain a better understanding of current adverse event (AE) analysis practices and the reasons for the lack of use of sophisticated statistical methods for AE data analysis in randomised controlled trials (RCTs), with the aim of identifying priorities and solutions to improve practice. DESIGN: A cross-sectional, online survey of statisticians working in clinical trials, followed up with a workshop of senior statisticians working across the UK. PARTICIPANTS: We aimed to recruit into the survey a minimum of one statistician from each of the 51 UK Clinical Research Collaboration registered clinical trial units (CTUs) and industry statisticians from both pharmaceuticals and clinical research organisations. OUTCOMES: To gain a better understanding of current AE analysis practices, measure awareness of specialist methods for AE analysis and explore priorities, concerns and barriers when analysing AEs. RESULTS: Thirty-eight (38/51; 75%) CTUs, 5 (5/7; 71%) industry and 21 attendees at the 2019 Promoting Statistical Insights Conference participated in the survey. Of the 64 participants that took part, 46 participants were classified as public sector participants and 18 as industry participants. Participants indicated that they predominantly (80%) rely on subjective comparisons when comparing AEs between treatment groups. Thirty-eight per cent were aware of specialist methods for AE analysis, but only 13% had undertaken such analyses. All participants believed guidance on appropriate AE analysis and 97% thought training specifically for AE analysis is needed. These were both endorsed as solutions by workshop participants. CONCLUSIONS: This research supports our earlier work that identified suboptimal AE analysis practices in RCTs and confirms the underuse of more sophisticated AE analysis approaches. Improvements are needed, and further research in this area is required to identify appropriate statistical methods. This research provides a unanimous call for the development of guidance, as well as training on suitable methods for AE analysis to support change.