SynthesisDrug safety2020
Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review.
Synthesis in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review.Pharmaceutical medicine · 2020Pooled it
- Implementation Science for Effective Risk Management of Medicines: A Call for Global Action.Drug safety · 2026Review
- Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint.Drug safety · 2025Article
- Review
- Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.Drug safety · 2024Article
- Article
- Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014-2018).BMC health services research · 2021Article
- Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014-2018) Using RE-AIM.Frontiers in public health · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRisk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety.
objectiveThe aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs.
methodsPeer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included.
resultsKey opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access.
conclusionsGaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine.
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.