Certain challenges remain in the use of registries, however, both in terms of tapping into the potential of existing registries and establishing new ones. The upcoming October workshop will further the discussion on the use of patient registries as a potential “real world evidence base” and examine some of the hurdles at hand. As we prepare for these conversations, we would like to highlight some of the challenges identified by pharmaceutical companies and regulators in the use of registries, including:

• The need for coordination between on-going initiatives at national and international levels;
• A desire for harmonised protocols, scientific methods and data structures;
• The importance of data sharing and transparency;
• Concerns regarding sustainability.

Our vision is that patient registries, whether health-service- or disease-based, will be maintained as a core part of health information infrastructure in the future. Only with the appropriate on-going upkeep can these registries effectively support healthcare systems in providing high-quality research platforms for the life sciences sector, with the ultimate aim of delivering quality care to patients.

What will it take to establish and maintain these registries in an effective and efficient manner? Long-term registries and networks should be established for priority diseases independently of specific product approvals and reimbursement processes. When new medicines are launched, these patient registries could be used to address outstanding research questions of regulators, Health Technology Assessment (HTA) bodies, payers, and clinicians. By linking these registries through international networks, the resulting impact can be enormous.

Additionally, by increasing the consistency and quality of these networks, we can subsequently inspire even greater confidence in the evidence derived from such registries and networks—further encouraging their usage. The more encompassing these registry networks can be made, the better they will be able to support the use of innovative, adaptive pathways for drug development, assessment, managed entry, and lifecycle benefit/risk monitoring.

Wherever possible, individual registries should apply common standards and definitions for disease outcome data. This will simplify linking of networks and research in the long run. To further support efficient research, there should be a clear process for researchers to access registry networks either by directly analysing anonymised data or by working through a registry’s own research group. The cost of research access should provide sustainable funding but not create a barrier to research.

Regulatory issues are also at stake. The simple creation and maintenance of a health-service- or disease-based patient registry should not be considered a study itself—and regulatory models need to acknowledge this. The regulatory framework for the creation and maintenance of a patient registry, for instance, should be defined separately from the regulatory framework for studies that use registry data to answer product or disease research questions. Registries that require primary data collection directly from patients might meet the test of “interventional” applied to studies, and should perhaps be redesigned as fixed studies rather than on-going registries. Such classifications must be consistent across EU Member States.

Last but certainly not least, clear rules for ethics approval, data privacy, and consent regarding registries must be established and applied consistently across Member States. Used effectively, patient registries can make for an important part of a country’s health information technology infrastructure, improving the delivery of healthcare and patient outcomes. Appropriate measures in the interests of patients should always come first. With this in mind, we look forward to the multi-stakeholder discussions to be held at the upcoming EMA Registries Workshop on 28 October 2016.