EMA publishes “A Common Data Model for Europe? – Why? Which? How?” Workshop Report
On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study in order to allow a combined analysis across several databases/datasets”. The report follows an EMA-hosted workshop in December 2017 to examine the opportunities and challenges of developing a CDM.
The report acknowledges that the use of ‘Real World Data’ (RWD) (data relating to patient health status or delivery of health care data that is routinely collected from sources other than clinical trials) has become an increasingly common source of evidence to support drug development and regulatory decision making for human medical use in Europe. However, Europe currently has no pan-European data network, despite the wealth of data generated through various national healthcare systems that provide access for all. Many multi-database studies currently performed are typically slow and still allow for substantial variability in the conduct of studies. Further, there are a growing number of innovative products that no longer align with customary drug development pathways. This may create uncertainty in their data packages required for authorization, and subsequent tension between facilitating earlier access for patients with limited treatment options against the requirement for proactive robust pharmacovigilance of medicines for wider clinical use across the product life cycle (the existing EMA Patient Registry Initiative addresses this need in part).
The EMA believes a Europe CDM could potentially “significantly accelerate” studies through a “ready for use” system and “improve reproducibility” via standardization of the evidence generation pathway. The report recognizes several key challenges and considerations in implementing a CDM in Europe, not least that any system must ensure robust data protection and governance, given the highly sensitive and personal nature of healthcare data and complexities of capturing and using RWD (such as cross-border transfers, and acquiring digital data from wearables and smart devices), combined with ensuring compliance with the requirements of the General Data Protection Regulation (GDPR).
The December workshop focused in particular on the technical pros and cons of two existing CDMs: the ‘Sentinel Common Data Model’ developed by the United States Federal Food and Drugs Administration (FDA), and the ‘Observational Medical Outcomes Partnership (OMOP) Common Data Model’ developed by the Observational Health Data Sciences and Informatics (OHDSI) global network.
The report sets out a series of “fundamental guiding principles” to be used in the development of a Europe CDM, with a view to addressing many of the limitations faced by existing CDM systems. In outline these principles address:
- Structure (including that the CDM must be intuitive, enable rapid answers when required, be efficient and feasible, and should be the simplest that achieves security, validity and data sufficiency);
- Operation/Governance (including to respect data privacy obligations across all data partners and regions, prioritize sustainability, and be dynamic, extendable and learn from experience);
- Quality of Evidence Generation (including that there must be transparency of how data is defined and documentation of its corresponding validation, and allow for reproducibility of data, tools, and study design to facility credible and robust evidence across multiple data sets); and
- Utility (including mapping all concepts commonly used in safety and effectiveness studies to maximize regulatory unity, and to provide a common set of baseline concepts that should enable flexibility when required and meets the needs of potential users).
For further details and the full principles, see the full text of the report, which can be found here: A Common Data Model for Europe? – Why? Which? How? – Workshop Report.
Harriet Fletcher contributed to this piece.