EMA, HMA Set 10 Priorities for Big Data

Regulatory NewsRegulatory News
| 20 January 2020 | By Michael Mezher 

A report from the European Medicines Agency (EMA) and Heads of Medicines Agencies’ (HMA) joint Big Data Task Force released Monday sets out recommendations to unlock the potential of data in medicines regulation.
“Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterize diseases, treatments and the performance of medicines in individual healthcare systems,” EMA writes.
The report is the second to come from the Big Data Task Force, after a summary report released in early 2019 provided a survey of the landscape for big data in the EU and highlighted areas related to medicines regulation that could be improved.
In the new report, the task force recommends steps for EU regulators to enhance their ability to collect, manage and interpret data to feed into the forthcoming EU Network Strategy to 2025.
The ten priority recommendations from the report include:
  • Deliver a sustainable platform to access and analyze healthcare data from across the EU
  • Establish an EU framework for data quality and representativeness
  • Enable data discoverability
  • Develop EU Network skills in big data
  • Strengthen EU Network processes for big data submissions
  • Build EU Network capability to analyze big data
  • Modernize the delivery of expert advice
  • Ensure data are managed and analyzed within a secure and ethical governance
  • Collaborate with international initiatives on big data
  • Create an EU big data ‘stakeholder implementation forum’
According to the report, the top priority is to establish an EU-wide platform to access and analyze health care data called the Data Analysis and Real World Interrogation Network (DARWIN), which is envisioned to launch by 2023.
“This platform would create a European network of databases of verified quality and content with the highest levels of data security. It would be used to inform regulatory decision-making with robust evidence from healthcare practice,” EMA writes.
However, the report emphasizes that big data “is not necessarily the solution to all the challenges faced by regulators” and that data from randomized controlled clinical trials “will remain the reference standard for most regulatory use cases.”
The report also provides “rough order of magnitude” estimates for the staff and resources required to deliver on the recommendations, including around 24 full-time equivalent (FTE) staff members for the first two years and 19 FTEs in year three, as well as €1.5 million in consulting fees and around €9.3 million in information technology and other costs over three years.
EMA, Report


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