(CSPOT29) Assessing use of the Reporting recommendation Intended for pharmaceutical Risk Minimization Evaluation Studies (RIMES) checklist in risk minimization evaluation studies in the EUPAS register

Background: Risk minimization measures (RMM) effectiveness studies are non-interventional (NI) post-authorisation safety studies (NI PASS) required by EMA to evaluate the effectiveness of risk minimisation measures. In 2017, a specific checklist tailored to RMM effectiveness studies was developed: Reporting recommendation Intended for pharmaceutical Risk Minimization Evaluation Studies (RIMES) checklist. The ENCePP Guide on Methodological Standards in Pharmacoepidemiology recommends the RIMES checklist, however the extent of its use is unknown.

Objectives: To assess and characterize the extent of RIMES checklist use in RMM effectiveness studies based on studies conducted in the EU/EEA and registered in EMA’s EUPAS Register (December 2017 to January 2024).

Methods: The EUPAS Register was searched in January 2024 to identify RMM studies with either the study registration date or last update date during December 2017-January 2024. Online information, study documents and appendix (if available), were reviewed and screened for the RIMES checklist. Study characteristics using RIMES were described, including availability of the study documents, use of ENCePP checklist, study status, NI PASS status, presence of ENCePP Seal, and type of RMM assessed.

Results: Overall, 242 studies were screened and 62 studies were included. Among the 180 excluded studies, 96 did not assess RMM effectiveness, 66 occurred outside of the study period, and 18 were conducted outside of the EU/EEA. Among the 62 included studies: 15 studies had protocols; 4 studies posted reports; 25 studies provided both protocols and reports; and 18 had neither a protocol nor report. While 31 studies used the ENCePP checklist, none of the available protocols used RIMES. Thirteen studies were ongoing, 13 planned, and 36 finalized. There were 53 NI PASS, 4 of which held the ENCePP Seal (1 PASS and 3 non-PASS). Routine RMM was assessed by 9 studies, additional RMM by 48 studies, and both by 5 studies.

Conclusions: Although RIMES was introduced over 6 years ago, its use has not been widely adopted. This study therefore highlights the need for broader adoption, in part, to increase the scientific validity of RMM effectiveness studies and to harmonize scientific principles of design, conduct, implementation and reporting.