The European Medicines Agency Bets Big on Big Data

The European Medicines Agency (EMA) and the European Union’s Heads of Medicines Agencies (HMA) have released an ambitious work plan for a collaborative steering group to address issues connected to big data in healthcare and drug development. 

The steering group’s work plan for 2021-2023, which was approved in June and released on Friday, intends to improve the utility of big data in regulation, from data quality to study techniques to assessment and decision-making. The group is striving for a patient-centered approach to integrating big data into public health, medication development, and regulatory procedures; the COVID-19 pandemic’s ongoing uncertainty necessitates a flexible implementation strategy. 

The steering committee seeks to incorporate real-world data into regulatory work through the Data Analysis and Real World Interrogation Network (DARWIN EU). The network’s implementation will begin in early 2022, with the goal of providing “routine access” to real-world evidence to the EU regulatory network by January 2023. 

A data quality workshop is planned for early 2022, with a draft data quality framework ready by mid-2022. Data quality is an issue that frequently plagues big data analytic methodologies. The steering group expects to offer recommendations before the end of 2022, based on technical discussions with the group Towards A European Health Data Space (TEHDAS). 

A closely connected project in TEHDAS will establish metadata recommended practice guide to “support the identification of relevant data for research and the interpretation of results submitted for regulatory decision-making, including studies through the DARWIN EU network.” 

An annex to the work plan lays out a list of ten priority suggestions that will serve as the basis for the steering group’s actions over the following two years. 

A data science curriculum, as well as biostatistics and pharmacoepidemiology curricula, will be added to the EU regulatory network by the end of 2021, as part of a focus on the network as a whole. Once continuous training needs are recognized, a “digital academy v1.0” will be ready by early 2023. 

Big data approaches can be used to perform pooled analysis of raw clinical trial data, which could be a useful tool for detecting safety and efficacy signals. According to the work plan, a pilot on data-driven interrogation of scientific information given as part of scientific advice requests and other sponsor communications will be undertaken to complement the work on raw data. Another objective is to have a draught guideline on the use of artificial intelligence in medicine regulation by the end of 2022, followed by a workshop on the subject in early 2023. 

The steering group hopes to improve EMA’s capacity to provide professional advice on big data applications and approaches by the end of 2022. The steering group also lays out a governance plan that will be fully implemented by early 2023, after which the mission will be reviewed and benefits evaluated officially. 

The steering group’s work within the EU will be accompanied by ongoing international collaboration on real-world evidence frameworks and a data standardisation plan. Plenary stakeholder forums will be held in December 2021 and November 2022, respectively. 

The work plan also includes a schedule for when different regulatory bodies will incorporate real-world evidence into their regular deliberations. 

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