Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey.

Introduction: The 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.

Methods: The 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.

Results: Among 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.

Conclusion: The 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.