ArticleDrug safety2021
Risk Management for the 21st Century: Current Status and Future Needs.
Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Implementation Science for Effective Risk Management of Medicines: A Call for Global Action.Drug safety · 2026Review
- Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies.Clinical pharmacology and therapeutics · 2025Article
- Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible.Therapeutic innovation & regulatory science · 2025Article
- Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists.Pharmaceutical medicine · 2024Article
- Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.Drug safety · 2024Article
- Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures.Current drug safety · 2024Review
- Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines.Pharmaceutical medicine · 2023Review
- Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.Drug safety · 2023Article
- Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities in health services; diversity, equity, and inclusion; and implementation science.Expert review of hematology · 2023Article
- Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.Therapeutic advances in drug safety · 2023Review
- Implementation of Interventions and Policies on Opioids and Awareness of Opioid-Related Harms in Canada: A Multistage Mixed Methods Descriptive Study.International journal of environmental research and public health · 2022Review
- Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach.Drug safety · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidence-based approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.
Indexed as
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.