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ABSTRACT
Objectives: The effectiveness of risk minimization measures (RMMs) requires evaluation. This study aims to evaluate the results of cross-sectional surveys assessing the effectiveness of RMMs in Europe (EU RM Surveys) and review the regulatory consequences.
Methods: The authors searched for study reports and manuscripts of completed EU RM surveys in the EU PAS Register, MEDLINE, and Google between 01/2011 and 01/2018. Regulatory responses were extracted from Assessment Reports. Random effects models to combine proportions were used.
Results: Twenty-four EU RM surveys were identified. Twenty-three studies targeted health-care professionals (HCPs). The pre-specified sample size was reached in 52% of studies. HCP participation was 5% defined as completers/invited and 89% for completers/eligible. Receipt of materials was recalled by 60% of HCPs and 77% of items scored knowledge >60%. Eight studies targeted patients/caregivers. The pre-specified sample size was reached in only two. Participation was 93%, defined as completers/eligible. Materials were received by 50–80% of patients and read by over 90%. Patients only scored knowledge >60% in 38% of items. Further action was requested by regulators in 59% of studies.
Conclusion: Surveys are necessary to evaluate many RMMs. Challenges remain in the design, conduct, and reporting of these studies which may benefit from the use of standard definitions and further guidance on reporting.
EU PAS Register: http://www.encepp.eu/encepp/viewResource.htm?id=23435
Article highlights
This systematic review and meta-analysis describes the results of 24 cross-sectional studies (surveys) assessing the effectiveness of routine or additional RMMs in Europe (EU RM Surveys) and the regulatory consequences.
Sixty percent of studies required further action based on regulatory assessment including distribution strategies, re-distribution, and follow-up assessment, changes to existing materials, further data awaited and, in a minority, removal of the materials.
Some challenges remain in the design (partly inherent to their cross-sectional nature), conduct and reporting of these studies, which may benefit from more detailed guidance, use of common definitions, standardization of reporting and adding other study designs.
Acknowledgments
We acknowledge the contribution of pharmaceutical companies, the EMA Access to Documents team and the ENCePP SIG on Impact of PV actions for facilitating access to study documents.
Authors’ contributions
E Artime and N Qizilbash were involved in the conception, design, and analysis of the research. S Pocock provided guidance on the conduct of the statistical analysis. E Artime and P Vora extracted and quality checked the data for analysis. All the authors contributed to the interpretation of the data, the drafting, and revision of the article, and approved the final version for publication.
Declaration of interest
E Artime and N Qizilbash are employees of OXON Epidemiology, a CRO that designs, conducts, analyses and reports risk minimization studies for pharmaceutical companies. P Vora, A Asiimwe and M Soriano are employees of Bayer, a pharmaceutical company that commissions risk minimization studies. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Supplementary material
Supplemental data for this article can be accessed here.