On 8 November 2018, the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes. The main objective of this initiative is to facilitate use of patient registries to support regulatory decision-making.
The discussion paper has been published to seek comments and suggestions from all the interested parties until 30 June 2019, in order to finalise the document in consultation with the relevant EMA committees by the end of 2019.
Fondazione Gianni Benzi participated in this consultation by highlighting the use of observational studies and patients’ registries as significant source to provide evidence of safety and efficacy of medicinal products.
Moreover, considering that cost-effectiveness-type analyses are becoming more important and registries can play a key role in such analyses, Fondazione Gianni Benzi suggested collecting information enough to be used for cost evaluations when designing a registry for cost-effectiveness analysis.