On 13 February, the European Medicines Agency (EMA) published the summary report of the Heads of Medicines Agencies (HMA)-EMA Joint Big Data task force.
This report is a comprehensive summary of the reports on six subgroups of data sources relevant to regulatory decision-making: genomics, bioanalytical ‘omics (proteomics, etc.), clinical trials, observational data, spontaneous adverse drug reactions data and social media and mobile health data. For each subgroup, a number of recommendations were issued. From these, several core recommendations and corresponding actions emerged which focused on 9 key areas:
|
Key area |
Core recommendation |
|
Data standardisation |
Promote use of global, harmonised and comprehensive standards to facilitate interoperability of data. |
|
Data quality |
Characterisation of data quality across multiple data sources is essential to understand the reliability of the derived evidence. |
|
Data sharing and access |
The development of timely, efficient and sustainable frameworks for data sharing and access is required. Further support mechanisms are needed to promote a data sharing culture. |
|
Data linkage and integration |
Promote mechanisms to enable data linkage to deliver novel insights. Facilitate harmonisation of similar datasets. |
|
Data analytics |
Develop clear frameworks to enable the validation of analytical approaches to determine if they are appropriate to support regulatory decision making Promote new analytical approaches for modelling of Big Data sets for regulatory purpose. |
|
Regulatory acceptability of Big Data analyses |
Regulatory guidance is required on the acceptability of evidence derived from Big Data sources. |
|
Medical devices regulation (MDR) / In vitro Diagnostics Regulation (IVDR) |
Ensure effective implementation of the new regulations for devices and invitro diagnostics (IVDs) associated with the use of medicinal products and monitor its impact in delivering safe and effective devices and IVDs. |
|
Skills and knowledge across the regulatory network |
Regulators must be equipped with the skills required for these emerging areas |
|
External communication and engagement |
Proactive regulatory engagement with external stakeholders relevant to the Big Data Landscape is needed in order to influence strategy and ensure regulatory needs are highlighted. |
This document is the result of several surveys that the task force sent to national regulatory agencies and the pharmaceutical industry. As such it provides a basis to understand the challenges and state of expertise in the field of Big Data.
Interestingly, the task force has defined the term ‘Big Data’ (for which there is no common-accepted definition) as “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly, and which may be analysed computationally to reveal patterns, trends and associations. In general, Big Data sets require advanced or specialised methods to provide an answer within reliable constraints.”
Next steps
Background
In 2017, the HMA and EMA established a task force on Big Data to assess the role of Big Data in the healthcare system. The group is exploring how regulators in the European Economic Area (EEA) can use Big Data to support research, innovation and robust medicines development to benefit both human and animal health.
More information is available in the summary report and the corresponding press release.
