Patient registries

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 an 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 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 the 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.

To support the initiative, EMA has set up a cross-committee task force on registries, comprising representatives from EMA scientific committees and working parties and experts from national competent authorities. EMA has published the task force's strategy and mandate:

Use of patient disease registries for regulatory purposes

On 8 November 2018 the cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes. The open consultation was closed on 30 June 2019. EMA will consider the comments and finalise the document in consultation with the relevant EMA committees by the end of 2019.

Inventory of registries

EMA has created an inventory of patient registries in the resources database of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The inventory aims to facilitate the interaction between stakeholders and existing patient registries.

EMA encourages patient registry owners whose registries are not listed in the inventory to add their registries to the database.

EMA also published a guidance document on how to search the ENCePP resources database for information about patient registries and on how to upload new registry details:

Stakeholder collaboration and workshop reports

EMA has held a stakeholder workshop to better understand the barriers and facilitators to collaboration between stakeholders. The workshop report which provides recommendations on actiions to improve stakeholder collaboration and optimise the use of registries to support regulatory decision-making:

EMA has also held disease-specific workshops where participants provided recommendations on the use of registries in these disease areas, including on core data elements, consents, governance, data sharing and interoperability. EMA has published the workshop reports which may act as models for guiding use of patient registries in other disease areas:

EMA has provided qualification opinions on two registries, the European Cystic Fibrosis Society (ECFS) patient registry and the Cellular Therapy module of the European Blood and Marrow Transplant (EBMT) registry, describing the contexts in which EMA considers the use of registry data suitable. They may also provide useful information for registry stakeholders on required data and quality standards:

The task force welcomes the opportunity to work with stakeholders in facilitating the development of implementation plans to support the delivery of the workshop recommendations.

It also welcomes feedback on these recommendations and interest from stakeholders in taking part in activities facilitating the use of registries for regulatory decision-making.

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