ReviewBritish journal of clinical pharmacology2026
Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post-authorization studies, 2022-2024.
Review in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post-authorization studies, 2022-2024.British journal of clinical pharmacology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
aimsRisk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre-specifying the targets, or 'thresholds', for assessing RMM effectiveness. We aimed to review recent industry-sponsored post-authorization safety studies (PASS) that evaluated the effectiveness of RMMs, focusing on the use and justification of predefined thresholds.
methodsWe searched the Heads of Medicines Agencies-European Medicines Agency Catalogue to identify PASS evaluating the effectiveness of RMM through knowledge-based surveys of healthcare professionals. A total of 17 eligible studies in 2022-2024 were included in the descriptive analysis.
resultsAll studies used cross-sectional designs, and 70.6% were Category 3 PASS. Only 29.4% evaluated RMM effectiveness within the guideline-recommended time frame (12-24 months) following the launch and regulatory implementation of RMMs. Nearly all studies (16 of 17, 94.1%) predefined effectiveness thresholds. Overall, thresholds ranged from 60% to 80%, with the majority (88.2%) being set at 80%. Thresholds for assessing awareness, knowledge, utilization and behaviours were set at 80%, 80%, 60%-80% and 75%-80%, respectively. However, only eight studies (47.1%) provided rationales for threshold determination. Among them, six studies justified thresholds based on success rates applied in comparable studies or regulatory guidance, while two relied on subjective criteria without specifying prior knowledge, experience or established scientific evidence.
conclusionOur findings suggest that although most industry-sponsored PASS evaluating RMM effectiveness included predefined thresholds, these were often applied to the knowledge indicator rather than awareness, utilization and behaviour indicators. Notably, only about half of the studies provided clear justifications for threshold selection. Clear success threshold justifications are essential for interpreting RMM effectiveness.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.