What assessment interval should I propose? What performance threshold level is acceptable?
It depends. FDAAA set a minimum assessment interval of 18, 36, and 84 months after REMS approval, but it appears FDA may be raising the bar by expecting more frequent testing in some situations. Initial assessment intervals of as early as 6 months and 12 months have increasingly been expected. Answering the question about needing a threshold and at what level is complex. There was an expectation about thresholds in the RiskMAP guidance, but the jury is out on this until REMS guidance is published. It is an important decision, as it affects sample size calculations, statistical methods, and the information collected to inform program improvement. A secondary question is “threshold for what?” If the measurement system is marketing research and the metric is patient understanding of the risk, then typical performance levels of 50-80% have been used as evidence that the program is effective. However, if the measurement system is claims data analysis and the metric is compliance with requir
