Patient registries

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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, explores 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:

Regulators and pharmaceutical companies 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;
  • sustainability.

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.

The initiative proposes a strategy to identify and evaluate existing data sources and develop a methodological toolkit for establishing new registries if needed.

To support the initiative, EMA set up a cross-committee task force on registries in 2014, comprising representatives from EMA scientific committees and working parties, representatives from the European Commission, and experts from national competent authorities.

Stakeholder collaboration

To better understand the challenges and barriers to collaboration between stakeholders, EMA held a stakeholder workshop in October 2016. The Agency published a workshop report in February 2017:

It recommends activities for EMA to undertake, in cooperation with the cross-committee task force, to improve stakeholder collaboration and optimise the use of registries to support regulatory decisions, taking account of feedback from the workshop. These include:

  • exploring mechanisms for regulators and marketing authorisation applicants to systematically consider the need for registries and interact with registry holders;
  • sharing and disseminating information on patient registries in specific disease areas;
  • recommending governance principles and standards for stakeholder interactions;
  • making recommendations on core data elements and quality standards acceptable for regulatory decision-making;
  • identifying registry holders' needs for methodological and technical guidance;
  • investigating what patient-reported outcomes registries should collect;
  • exploring further measures to improve the sustainability of registries.

Together with the cross-committee task force, EMA will develop an implementation plan to support the delivery of these activities. 

The task force will adapt its governance structure, strategy and communication activities to reflect changes in its role.

The Agency welcomes feedback on the report's recommendations and interest from stakeholders in taking part in these activities.

In 2017, EMA will organise two stakeholder workshops on patient registries in specific disease areas, to provide recommendations on details such as data elements, protocols, consents, registry governance and interoperability. These will act as models for best use of patient registries in other disease areas.

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