Big Data Highlights

Do you hold or know someone who holds a data source? Join us in unlocking the potential of real-world data (RWD) by registering your data source in the Catalogue of RWD sources or encouraging others to do so.

EMA has published a summary guide for EU regulators and decision-makers on how the Agency can support the delivery of regulator lead real-world evidence to aid decision-making. The guide includes descriptions of the available types of real-world data studies, optimal resources for addressing research questions and details about the process for requesting these studies.

A reflection paper on non-interventional studies that use real-world data to generate real-world evidence for regulatory purposes is available for public consultation. All interested partners and stakeholders are invited to provide feedback by 31 August 2024.

ICH adopted a reflection paper to further enable real-world evidence integration into regulatory decision-making across the world. Furthermore, the ICH M14 draft guideline on non-interventional pharmacoepidemiological studies for safety assessment of medicines is open for public consultation until 30 August 2024.

The report on the workshop, which focused on the registries use for regulatory purposes, is now available. It summarises the discussions and highlights recommendations to optimise the qualification of novel methodologies for patient registries. The report also identifies ways to improve data quality, discoverability and assess the fitness for purpose of data sources for regulatory decisions.

The ACT EU workshop on 25-26 January 2024 highlighted a collective ambition to improve the use of data about clinical trials, with a multi-stakeholder approach to identify research priorities. This will speed up the development of an analytics ecosystem that maximises health benefits for EU citizens. A report summarising the discussion has been published on the ACT EU website.