Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies

Abstract

Insights into the time needed for evaluation of risk minimization measures' (RMMs) effectiveness might identify areas for improvement. We assessed the duration of time intervals between regulatory milestones for RMM effectiveness studies assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). We included completed RMM effectiveness post-authorization safety studies (PASSs) assessed by PRAC between 2016 and 2022. Regulatory documents submitted by marketing authorization holders and assessment reports were extracted from non-public EMA databases. To calculate the duration of time intervals, we collected the dates of study request, protocol assessment start, protocol approval, study start, final study report assessment start, and final study report PRAC outcome. We identified 98 PASSs. The median duration from study request to final study report PRAC outcome was 52 months (Q1–Q3: 40–70). The median duration from study request to study start was 21 months (Q1–Q3: 15–30; n = 95) and from study start to final study report assessment start was 21 months (Q1–Q3: 13–36; n = 95). The final study report assessment often comprised <6 months (median: 4; Q1–Q3: 1–6). For PASSs with a PRAC-approved protocol (n = 80, 81.6%), the median duration of protocol assessment was 7 months (Q1–Q3: 4–10). Concluding, the median duration from study request to RMM effectiveness PASS completion exceeded 4 years. Next to the study conduct duration, the period from study request until study start was the most time-consuming. The duration of this period might be minimized by improved guidance on RMM effectiveness PASSs and encouraging timely protocol submission.