Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide adequate source of post-authorisation data for regulatory decision-making.
The initiative for patient registries, launched in September 2015, will explore ways of expanding the use of patient registries by introducing and supporting a more systematic and standardised approach to their contribution to the benefit-risk evaluation of medicines within the European Economic Area:
Pharmaceutical companies and regulators currently face a number of challenges in using existing registries or establishing new ones, including a lack of:
- coordination between ongoing initiatives at national and international levels;
- harmonised protocols, scientific methods and data structures;
- data sharing and transparency;
These factors have led to inefficiency and a duplication of efforts. To address these problems, the EMA initiative seeks to create a European Union-wide framework on patient registries, facilitating collaboration between:
- registry coordinators, such as physicians’ associations, patients' associations, academic institutions or national agencies responsible for overseeing healthcare services;
- potential users of registry data, such as medicines regulators and pharmaceutical companies.
Update: On 28 October 2016, EMA will hold a stakeholder workshop to discuss the challenges and barriers to collaboration and to identify concrete solutions:
- Patient registries workshop (28/10/2016)
EMA will broadcast the workshop live and publish the recording and a meeting report on the event page.
A cross-committee task force on registries, comprising representatives from EMA scientific committees and working parties, representatives from the European Commission, and experts from national competent authorities supports the initiative. EMA set up the task force and 2014.
Strategy on registries
The initiative proposes a strategy to identify and evaluate existing data sources and develop a methodological toolkit for establishing new registries if needed.
The strategy starts from the stage where an EMA committee identifies the need to gather additional data on a medicine from real-life clinical use, before or following the medicine’s authorisation, or when an applicant or marketing-authorisation holder independently identifies this need. The proposed approach includes the following steps within the current regulatory framework:
- identify and evaluate existing data sources including national databases, electronic health records and existing patient registries;
- determine if the need for data is best addressed through a registry;
- investigate with registry coodinators the possibility to amend or extend an existing registry if needed;
- defining the core components of a new registry as applicable.
The identification of adequate existing data sources is the responsibility of the applicant or marketing-authorisation holder, but EMA may facilitate interactions between stakeholders, including registry custodians, Member States and EMA committees and working parties, as part of the strategy.
EMA will also facilitate access on this page to:
- an inventory of existing patient registries;
- a toolkit of methodological guidelines to evaluate data quality;
- standard sets of data elements for new registries.
The initiative starts with a pilot phase to test different components of the patient registry strategy and if it meets regulators' and other stakeholders' data and information requirements.
EMA will include medicines in the pilot based on expressions of interest by applicants or marketing-authorisation holders and a selection by the cross-committee task force, in cooperation with the responsible EMA committee rapporteurs and the pharmaceutical companies concerned.
The cross-committee task force on registries will discuss lessons learned and input from stakeholders on how to make better use of patient registries. EMA will publish recommendations for continuing the work on patient registries at the end of the pilot phase, which is expected by the end of 2017.
How useful is this page?
Average rating:Based on 31 ratings
Add your rating:
- See all ratings
1 ratings0 ratings1 ratings4 ratings25 ratings
- Briefing note to marketing authorisation holders/applicants on the European Medicines Agency Patient Registry Initiative (2016-04-15)
- Initiative for patient registries - Strategy and pilot phase (2015-10-12)
- Presentation - Strategy and pilot phase for patient registries (Xavier Kurz) (2015-03-12)
- Agenda - Patient registries workshop (2016-10-20)