ReviewDrug safety2025
Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey.
Review in Drug safety, 2025. 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.
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
introductionThe Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) checklist is endorsed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and is tailored for studies assessing Risk Minimisation Measures and Risk Evaluation and Mitigation Strategy (RMM/REMS) effectiveness; however, its awareness and usage remain unknown. We evaluated the implementation of the RIMES checklist in RMM/REMS effectiveness studies registered in the EUPAS register during 01 December 2017- 01 January 2024. Furthermore, the awareness and utilization of the RIMES checklist among researchers conducting RMM/REMS effectiveness studies was assessed.
methodsThe European Union Post-Authorisation Study (EUPAS) Register was reviewed to identify studies conducted in at least one European country within the specified timeframe. Data were extracted from the online EUPAS registrations, including uploaded study documents. Additionally, a survey was distributed through at International Society of Pharmacoepidemiology (ISPE) to assess awareness and checklist utilisation among researchers. Findings from both the review and the survey were reported descriptively.
resultsAmong 44 studies included in the review, cross-sectional questionnaire-based surveys (n = 28, 64%), and retrospective cohort studies using secondary data (n = 13, 30%) were frequently used study designs. Oncology (n = 12, 27%) and pregnancy-related conditions (n = 7, 16%) were frequently reported therapeutic areas. Most studies were required by regulators and typically evaluated the additional RMM/REMS. The awareness and usage of the RIMES checklist was low, while the ENCePP checklist was used frequently. Some researchers considered the ENCePP checklist adequate for RMM/REMS studies, while few advocated for the RIMES checklist.
conclusionThe awareness and utilisation of the specific RIMES checklist designed for studies evaluating RMM/REMS was limited, indicating a need for improving awareness and utilisation of RIMES and harmonisation of existing guidance and frameworks for RMM/REMS effectiveness studies.
Indexed as
Identifiers
39688763What 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.