A third workplan with measures due by 2025 has been released by the joint Big Data Steering Group of the European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA).
The new strategy, according to EMA, will improve the integrated approach of data analysis into the regulatory assessment of pharmaceuticals. The agency issued a statement in which it declared that using revolutionary technology and the evidence generated by big data would enhance public health by expediting drug development, enhancing treatment outcomes, and easing early patient access to novel treatments.
The HMA/EMA Big Data Steering Group evaluates its workplan every year to include any newly emerging areas of interest. The group was established in May 2020 to provide guidance to both the EMA and HMA on the execution of the ten priority recommendations identified by the Big Data Task Force. The new strategy principally focuses on initiatives connected to medications for humans while adhering to the primary recommendations of the previous Big Data Task Force.
The work plan details deadlines and deliverables, including:
- By 2025, the EMA’s network of data and services in Europe will have more than 100 studies each year, which will allow for a better use of real-world evidence for evaluating medications.
- By the end of 2022, the EU regulatory network will have a data quality framework that is based on analysis and discussions about data quality with a variety of stakeholders, including patients, healthcare workers, regulators, the pharmaceutical industry, and academics.
- Release of a public European real-world data catalogue and a good practise manual on real-world metadata to improve data discoverability. The creation of analytics tools and uniform clinical trial methods will also improve the ability to search for information in regulatory documents.
- Under the heading of “EU network skills,” the provision of training in biostatistics, pharmacoepidemiology, and data science for policymakers with specialised access for patients, medical professionals, and academics.
Big data are very big, fast-growing datasets that are collected using a variety of settings and equipment, such as wearable technology and electronic health information. The EMA and HMA suggest that big data, when combined with rapidly advancing technology, can supplement the substantiation from clinical trials by filling in knowledge gaps about a medicine and aiding in a better understanding of diseases, treatments, and the effectiveness of medications in various healthcare systems.
