ReviewDrug safety2014
Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.
Review in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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
32 citing papers in PubMed.
- Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods Using Real World Data.Learning health systems · 2026Article
- Impact of diclofenac risk minimization measures addressing cardiovascular risk on analgesic use in musculoskeletal disorders.British journal of clinical pharmacology · 2025Article
- Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and Oversight.Therapeutic innovation & regulatory science · 2025Article
- Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies.Clinical pharmacology and therapeutics · 2025Article
- Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.Drug safety · 2023Article
- Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark.Journal of clinical medicine · 2023Article
- A flexible mixed-data model applied to claims data for post-market surveillance of prescription drug safety behavior.Pharmaceutical statistics · 2022Article
- Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union.Pharmaceutical medicine · 2021Article
- A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.Pharmacoepidemiology and drug safety · 2021Review
- Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities.Drug safety · 2021Review
- Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe.Pharmaceutical medicine · 2021Article
- Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands.Drug safety · 2020Article
- Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non-small cell lung cancer (NSCLC) in Europe.Pharmacology research & perspectives · 2020Article
- Article
- Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.Frontiers in pharmacology · 2020Article
- Ivabradine drug utilization study in five European countries: A multinational, retrospective, observational study to assess effectiveness of risk-minimization measures.Pharmacoepidemiology and drug safety · 2019Observational
- A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool.Drug safety · 2019Article
- Measuring the impact of pharmacovigilance activities, challenging but important.British journal of clinical pharmacology · 2019Article
- Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature.Drug safety · 2019Review
- Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures.Pharmaceutical medicine · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Evaluation of the effectiveness of drug risk-minimisation measures is mandatory for both risk evaluation and mitigation strategies (REMS) in the United States and risk management plans in the European Union (EU-RMPs). Such evaluations aim to assess the impact of risk-minimisation measures on the knowledge, attitudes or behaviours of healthcare professionals or patients, the incidence of safety concerns, and their impact on the overall benefit-risk balance. Although many effectiveness evaluation models and methods are available, regulatory guidance and policy are still evolving. This paper considers evaluation strategies, challenges in evaluating risk minimisation post-authorisation, possible outcome measures and their interpretation, and potential emerging regulatory policy issues. Particular challenges include appropriate data collection, perceived and real burdens of performing evaluation on clinical practice, lack of comparators and benchmarking, and uncertainty about the best outcome measures.
Indexed as
Identifiers
24357107What 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.