EMA Guidance On Registry-Based Studies Due This Month
Executive Summary
The European Medicines Agency is planning an October workshop to discuss its new guideline on registry-based studies and to discuss recent experience on aspects such as the use of a large registry for clinical trials.
The European Medicines Agency has developed draft guidance on the methodological aspects of registry-based studies that drug sponsors can undertake to generate scientific evidence on their medicinal products in the pre- or post-authorization setting.
The guideline, which is due to be issued soon, is relevant to those participating in the collection and analysis of registry data and those planning to use the registry information and infrastructure to perform registry-based studies with a possible regulatory purpose. It is also relevant for patients and those involved in funding, creating and managing registries, the EMA said.
An annex of the draft guideline reviews aspects of patient registries that the regulators consider good practice for regulatory purposes in general and for registry-based studies more specifically. The guideline also outlines the relevant legal basis and regulatory requirements for marketing authorization applicants and holders undertaking registry-based studies.
The draft guideline is expected to be issued for public consultation at the end of September and will be followed by a virtual workshop on 19 October to provide stakeholders with an opportunity to seek clarification on its content.
Discussions at the EMA workshop will focus on, among other things, recent experience with methodological aspects of registry-based studies, such as the use of a large registry for clinical trials. Topics listed for discussion include experience with randomization within a registry, data quality and data verification in registries and collection of safety information linked to medicinal products through registries.
The draft guideline was prepared by the EMA’s Cross-Committee Task Force on Registries. It builds on a 2018 discussion paper issued by the task force on the “methodological and operational considerations in the use of patient disease registries for regulatory purposes.” (Also see "EMA Outlines Regulatory Expectations On Use Of Patient Registries" - Pink Sheet, 13 Nov, 2018.)
The registries task force was established in response to an EMA initiative launched in September 2015 to address the challenges faced by regulators and pharmaceutical companies in using existing registries or establishing new ones, such as the lack of harmonized protocols, scientific methods and data structures, etc. The initiative aims to create an EU-wide framework on patient registries by facilitating collaboration between registry coordinators and potential users of registry data. (Also see "EMA explores making better use of patient registries to support drug evaluation " - Pink Sheet, 19 Jun, 2015.)