EMA goes all in on big data

Regulatory NewsRegulatory News | 27 August 2021 |  By 

The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.
The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage. The group is aiming for a patient-focused approach to the integration of big data into public health, drug development, and regulatory approaches; persistent uncertainties related to the COVID-19 pandemic also necessitate a flexible approach to implementation.
The Data Analysis and Real World Interrogation Network (DARWIN EU) is a key means by which the steering group plans to incorporate real-world data into regulatory work. Implementation of this network will begin in early 2022, with a plan to give the EU regulatory network “routine access” to real-world evidence by January of 2023.
Attention to data quality — an issue that often plagues big data analytic approaches — will be addressed with a planned data quality workshop in early 2022, with a data quality framework draft readied by mid-2022. Technical discussions with the group Towards A European Health Data Space (TEHDAS) will continue, and the steering group plans to issue recommendations before the end of 2022.
Closely related work will loop in TEHDAS to develop a good practice guide for metadata to “support the identification of relevant data for studies and the interpretation of results submitted for regulatory decision-making, including studies through the DARWIN EU network.”
A focus on the EU regulatory network as a whole will see the addition of a data science curriculum for the network by the end of 2021, along with biostatistics and pharmacoepidemiology curricula. A “digital academy v1.0” will be ready by early 2023 once ongoing training needs are identified.

Big data techniques can be leveraged to accomplish pooled analysis of raw clinical trial data, a potentially powerful tool for safety and efficacy signal detection. “To complement the work on raw data, a pilot will be run on data driven interrogation of scientific information submitted as part of scientific advice requests” and other sponsor communications, according to the work plan. A further goal is to have a draft guideline on the use of artificial intelligence in the regulation of medicines by the end of 2022, followed by a workshop on the topic in early 2023.
The steering group plans to strengthen EMA capacity to offer expert advice on big data utilization and methodologies, accomplishing the task by the end of 2022. The steering group also lays out a governance plan that will be fully implemented by early 2023, at which point the mandate will undergo a formal review and benefits assessment.
Ongoing international collaboration on real world evidence frameworks and a data standardization strategy will accompany the within-EU work of the steering group. Plenary stakeholder forums are planned for December 2021 and November 2022.

The work plan also details a timeline for when various regulatory committees will integrate real-world evidence into their routine deliberations. An annex to the work plan lays out a set of 10 priority recommendations that form the framework for the planned activities of the steering group over the next two years.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you