Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have established a joint task force to investigate the potential role of ‘big data’ in the context of medicines development and regulation in the European Union (EU).
'Big data' is a widely-used term without a commonly-accepted definition. The HMA/EMA Task Force on Big Data defines big data 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’.
Medicines regulators will increasingly use insights derived from big data to assess the benefit-risk of medicines across their lifecycle. However, in order to benefit from and make prudent use of the data collected, regulators need a deeper understanding of the data landscape.
The sources of such data include real-world data (such as electronic health records and data from Patient registries), genomics, clinical trials, spontaneous adverse drug reaction reports, social media and wearable devices.
A single dataset may not strictly meet the definition of big data but, when pooled with or linked to other datasets, they become sufficiently large or complex to analyse for the data to assume the characteristics of big data.
The HMA/EMA Task Force on Big Data has assessed the generation of ‘big data’, their relevant sources and main formats, the methods for processing and analysing big data and the current state of expertise across the European medicines regulatory network.
In February 2019, the task force published a summary report containing its recommendations for a path towards understanding the acceptability of evidence derived from big data in support of the evaluation and supervision of medicines:
The task force invites stakeholders to submit comments on the core recommendations in the summary report by 15 April 2019 to firstname.lastname@example.org.
In particular, views on prioritisation of future actions are welcome. The task force will take account of feedback received in the next phase of its work.
The task force characterised data relevant to regulatory decision making in the fields of genomics, bioanalytical ‘omics (proteomics, etc.), clinical trials, observational (real-world) data, spontaneous adverse drug reactions data, social media and mobile health data.
The topic of big data also features in EMA's strategic reflection on Regulatory Science to 2025. EMA invites stakeholders to submit comments on this document by 30 June 2019.
The HMA/EMA Task Force on Big Data was set up in March 2017 to discuss the challenges and opportunities posed by big data in medicines regulation.
It is composed of experienced medicines regulators from fourteen national competent authorities and EMA. It aims to:
- map the sources and characteristics of big data;
- explore the potential applicability and impact of big data on medicines regulation;
- assess the need for changes to regulatory guidelines or legislation;
- create a roadmap for the development of big data capabilities in the national competent authorities;
- collaborate with other regulatory authorities and partners outside the European Economic Area (EEA).
The task force began by undertaking a detailed landscaping of the big data field as viewed through the lens of the regulator. It performed online surveys of national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This helped develop an understanding of the challenges and the current state of expertise in the regulatory network.
For more information, see HMA/EMA Task Force on Big Data.
In May 2018, the task force held a workshop to inform thinking on big data and related challenges, which fed into its recommendations published for consultation in February 2019:
For more information, see:
- Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges (04/05/2018)
EMA also held a Workshop on identifying opportunities for 'big data' in medicines development and regulatory science in November 2016.