New EU report on big data paves the way for action

01 March 2019

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real world data. These are some of the data sets that the HMA/EMA Joint Big Data Taskforce has examined more closely, including the potential of making better use of the data sets in the development and monitoring of new medicines. 

”The report is the first step to address the most important challenges facing the authorities and the life science industry when it comes to using big data”, says Nikolai Brun medical director in the Danish Medicines Agency and chair of the European taskforce. "We have identified the most important areas, and the next step is now to find out how and when to start addressing the different challenges. I can say straight away that the taskforce agrees that one of the most important things is for the European authorities to expand its skill base when it comes to making complex analysis of large data sets and deriving benefit", says Nikolai Brun.

The big data taskforce has been formed by the heads of the drug regulatory authorities in Europe, known as the Heads of Medicines Agencies, and the European Medicines Agency (EMA). The purpose of the taskforce is to map and characterise the most relevant data sources and identify how the data sets can be used to develop new and better medicines while ensuring the protection of personal data.

"A lot of companies are investing heavily in building systems so they can use data more strategically in the future. It is important that the authorities are able to match this development, and we at the Danish Medicines Agency are therefore very pleased that the government has committed to supporting a data analysis centre that will be placed at the Danish Medicines Agency. It will enable Denmark to take the lead in this area", said Nikolai Brun.

Common definition of big data

The European taskforce has reached an important milestone by providing a definition of big data because the term is used in many different contexts today.

The taskforce has defined 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’.

The definition provides the basis for the scope of the taskforce's further efforts, some of which take place in seven subgroups that focus on clinical trials, real world data, spontaneous ADR data, social media, genomics, biostatistics and data analytics. 

As part of the report, six of the subgroups have submitted a total of 47 specific recommendations, and the data analytics subgroup is expected to deliver its final recommendations by the end of the first quarter of 2019. 

Comments to the report and the work of the taskforce are welcome

Follow this link to download the taskforce's report: HMA-EMA Joint Big Data Taskforce.

We encourage all stakeholders to send their feedback and comments to the recommendations, maximum 1000 words, by email to bigdatasec@dkma.dk by 15 April 2019. We especially welcome views on the prioritisation of future actions.

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