The Big Data Steering Group jointly established by the European Medicines Agency (EMA) and the network of heads of medicines agencies in the EU, the Heads of Medicines Agencies Organization (HMA), published its third workplan for 2022-2025 this summer. The goal of the Big Data Workplan 2022-2025 is to improve the integration of data analytics into medical product or clinical trial evaluations by health regulators.
This workplan was developed based on the recommendations of the joint EMA-HMA Big Data Task Force, which was composed of experienced drug regulators and data experts nominated by national competent authorities, the EMA, and the European Commission.
This HMA/EMA Big Data Task Force operated from 2017 to December 2019 to highlight the challenges and opportunities posed by megadata in drug regulation.
In a first phase, the working group has:
- Examined the megadata landscape from a regulatory perspective and identified opportunities to improve the functioning of drug regulation;
- Conducted online surveys of national regulatory agencies and the pharmaceutical industry on perspectives, expertise, and challenges, highlighting challenges and the current state of expertise in the regulatory network.
In the second phase, the working group developed 10 priority recommendations in 2020 to inform strategic decision-making and planning by the HMA and EMA, contributing to the work of the European Medicines Regulatory Network.
The ten priority recommendations aim to:
- Provide a sustainable platform for accessing and analyzing health data from across the EU (Data Analysis and Real World Query Network -DARWIN);
- Establish a European framework for data quality and representativeness;
- Activate data discovery capability;
- Develop EU network competencies in the area of big data;
- Strengthen EU network processes for megadata submissions;
- Strengthen the EU network’s capacity to analyze big data;
- Modernize expert advisory delivery;
- Ensure data is managed and analyzed within a secure and ethical governance framework;
- Collaborate with international initiatives on big data;
- Create an EU “stakeholder forum” on megadata implementation.
The Big Data Steering Group, HMA/EMA steering group
The joint HMA/EMA Big Data Steering Group advises EMA and HMA on prioritizing and planning actions to implement these ten recommendations.
Co-chaired by Jesper Kjær, Director of the Data Analysis Center at the Danish Medicines Agency, and Peter Arlett, Head of Data Analysis and Methods at EMA, it began its work in May 2022. Each year, it revises the work plan to cover any new emerging topics, so the last update was in July 2022.
The Third Work Plan 2022-2025
The joint HMA-EMA Big Data 2022-2025 work plan follows the key recommendations and includes primarily human drug-related activities. However, the scope of some activities covers veterinary aspects and a separate section of the work plan is entirely dedicated to veterinary drugs.
However, its implementation will be flexible and some actions may be rescheduled, as the European Medicines Regulatory Network must prioritize the unprecedented public health challenge of the Covid-19 pandemic.
It presents deliverables and timelines, including for the following areas:
- Data Analysis and Real World Interrogation Network (DARWIN EU), the EMA’s data and services network in Europe for better use of real world evidence in drug evaluation: the work plan calls for more than 100 DARWIN EU studies per year by 2025 ;
- Data quality: a data quality framework for the EU regulatory network is to be delivered by the end of 2022, following analysis and exchanges on data quality with a wide range of stakeholders, including patients, healthcare professionals, regulators, the pharmaceutical industry and academia;
- Data discovery: the publication of a best practice guide on real-world metadata and a public catalog of European real-world data are planned, as well as the development of analysis tools for better information retrieval and the development of standardized clinical trials;
- EU network skills: the work plan includes the provision of training on biostatistics, pharmacoepidemiology and data science for regulators with targeted access for patients, healthcare professionals and academics.